instantgmp, inc. - title: document no: csvp-um-igmp- 3.001.101 … · 2020-06-04 · instantgmp...

Title: CSVP – InstantGMP™ User Manual-3.001.101

Document No: CSVP-UM-IGMP-3.001.101

Effective upon last signature date

Page: 1 of 140

1

InstantGMP User Manual for MES Note: IGMP now runs best in Chrome: download desktop version

Note: please change any personnel with ADM role meant to sign for PM or QM signatures to reflect those roles, as the ADM and Site admin roles have recently changed and the ADM has no signature rights and can only create new personnel. The ADM is no longer automatically assigned to projects. Contact your InstantGMP Support Associate for screenshots or a Join.me session if you are having difficulty doing so. Most Recent Release Notes: (see end of document for older release notes) InstantGMP MES 3.001.101______________________________________________9/1/2016

New Functionalities

• Now you can create BPRs directly from the MPR • Now you can Hide Materials

o Hidden materials will not show on: Material lists Specifications Requisitions Projects MPR and BPR where hidden Material is WIP or FG will be hidden as well

o Hidden materials will show on: Inventory Reports

Improvements Fixes

• When receiving material “Used By” date were not properly saved • Minor spelling errors

Version History

Version Date (MM/DD/YY

YY)

Description of Change

00 02072014 New Document 01/ 2.045 070214 Made changes for the new Unit table/page/workflow.

https://www.google.com/chrome/browser/desktop/




Page: 2 of 140

2

02/ 2.045.008 09/10/14 Updated the new specification workflow.

03/2.045.009 11/17/14 Updated with new batch material use workflow

04/2.050.001 05/18/2015

The default Role can be assigned from the personnel screen. Personnel may login immediately after role assignment on this screen. (p 21) Added Optional Features section (p20) Added note about ability to sort by batch issuance stamp (p89) Deleted signatures for Material vendor qualification and updated screen shot. (p 39) Updated new specification workflow (pp 40-45) Updated reports to reflect being sourced from within GeneXus. (pp 99-102)

05 / 2.051.002 07/22/2015

Added a section for the new barcode scan features for user badges and material labels. Added Sign with badge add tests and browse buttons to icon glossary. Edited Order to sort with new icon in glossary.

06/ 2.052.001 12/2/2015

Deleted CPC, addressed client change, deleted : Selecting “Y” from the “Qualified Vendor” dropdown will return all materials that have qualified vendors. “N” will return all materials whose vendor has not been qualified. “Clear” will return all materials.”

2.053.002 12/13/2016 project changes, Product name, Primary container, copy function, version up function, scale up function,

2.054.002 05/09/2016 Min max patch – new error messages 3.000.001 05/09/2016 See release notes below

3.000.002, 3.000.004, 3.000.101, 3.000.102,

08/05/2016

Only active users counted in # of users, specifcation version shown on all read only spec data pages MPR ID # auto assigned New batch Number formula: MPR # + MPR Version + BPR # increment. Material label dimension changed to 2:1 Added * to mandatory fields Searches work for secondary words; Date format toggle Lots of new columns and data on main panels Print option for MPR and BPR on HWW screens Scale integration ADM no longer added to projects Attachment corruption issue fixed




Page: 3 of 140

3

3.001.101 09/07/2016

Hide materials, Create BPRs directly from MPR R1611 - Hide Materials R1619 - Allow a BPR to be generated directly from an MPR D929 - receipt and status labels missing use by date D931 - scan and get wt popup confirm spelling

Table of Contents

Table of Contents ............................................................................................................................ 3 User Manual Summary ................................................................................................................... 4 Overview of Main Menu and Sub-menu choices ........................................................................... 5 Abbreviations .................................................................................................................................. 7 Definition Glossary ......................................................................................................................... 9 Icon Glossary ................................................................................................................................ 12 Manufacturing Process Overview ................................................................................................. 18 Starting a New Project .................................................................................................................. 18 Set-Up ........................................................................................................................................... 20

Adding Personnel ...................................................................................................................... 20 Vendors ..................................................................................................................................... 22 Material Types .......................................................................................................................... 24 Material Status .......................................................................................................................... 26 Storage Condition ..................................................................................................................... 28 Unit ........................................................................................................................................... 28 Facility ...................................................................................................................................... 30 Room ......................................................................................................................................... 30 Bin Location.............................................................................................................................. 31 Equipment ................................................................................................................................. 32 Tests .......................................................................................................................................... 33 Methods..................................................................................................................................... 34 Countries ................................................................................................................................... 35

Material ......................................................................................................................................... 37 Material Specifications ................................................................................................................. 40 Creating a Project .......................................................................................................................... 45

Project Definition ...................................................................................................................... 45 Requisitions................................................................................................................................... 53 Inventory ....................................................................................................................................... 56

Material Receipt ........................................................................................................................ 56 Inventory Status ........................................................................................................................ 59 Inventory Management ............................................................................................................. 62 Inventory Location .................................................................................................................... 65




Page: 4 of 140

4

Depleted Inventory.................................................................................................................... 66 Master Batch Records ................................................................................................................... 71

Master Record Cover Page ....................................................................................................... 74 Master Record: Bill of Materials .............................................................................................. 76 Master Record Equipment ........................................................................................................ 79 Master Records In-Process Tests .............................................................................................. 80 Master Production Record Manufacturing Instructions ............................................................ 81 Master Record: MPR Approvals ............................................................................................... 87 Batch Production Cover Page ................................................................................................... 91 Batch Record Manufacturing Instructions ................................................................................ 96 Batch Record Approval........................................................................................................... 103

Audit Log .................................................................................................................................... 105 Reports ........................................................................................................................................ 108 Barcode ....................................................................................................................................... 111 Advanced Topics: Hiding Materials ........................................................................................... 119 Special Functions ........................................................................................................................ 121

Preparation for automated weight recording ........................................................................... 121 Serial Interface App ................................................................................................................ 123 Scan and Get Weight during batch manufacturing ................................................................. 127

_____________________________________________________________________________

User Manual Summary This user manual is set up to use Process Flow Diagrams and a training exercise to illustrate the functions and business rules of the InstantGMP™ MES and the InstantGMP™ VAPE applications. The training exercise will lead you through the procedures and data entry steps that will allow for the production of a batch of encapsulated powder.

InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP manufacturing of any FDA regulated product. It includes entry screens for documenting personnel information, room activity and equipment histories, project and vendor information, raw materials and test specifications, purchase orders and inventory tracking as well as Master Production Records and Batch Production Records.




Page: 5 of 140

5

InstantGMP runs best in Chrome. Please download the free browser: https://www.google.com/chrome/browser/desktop/index.html InstantGMP runs on PCs and Macs as well as Windows based tablets (Full version of windows not RT) and iOS. Overview of Main Menu and Sub-menu choices There are eight (8) Main Menu choices that reside at the left of the opening screen. Each of them have additional sub-menus choices. The following main menu choices are found to the left of the main application screen. They contain sub-menu choices which are selected to enter in data.

1. Setup 2. Materials 3. Specifications 4. Requisitions 5. Inventory 6. Logs 7. Project 8. Batch Record 9. Audit 10. Reports

Sub-menus (signified by bold grey text e.g. Set-Up Personnel:) The main menu choices have sub-menus from which to choose in order to complete various activities. For example, Set-Up consists of sub-menus that open data tables. The Personnel table contains the names and contact information of personnel. The Vendor table contains the names and contact information of various material vendors.

1. Set Up

a) Personnel b) Vendor c) Material Type (raw materials, components, WIP, Finished Goods, etc.) d) Material Status (Approved, Quarantine, Rejected) e) Storage Condition f) Unit g) Facility h) Room i) Bin j) Equipment k) Tests l) Methods m) Countries




Page: 6 of 140

6

2. Material (including Finished Goods, WIP, and Raw Materials) 3. Specifications

a) Add Material Specifications b) View Material Specifications

4. Requisitions 5. Inventory

a) Material Receipt b) Inventory Status (quarantined, approved, etc.) c) Inventory Management d) Depleted Inventory

6. Project a) Project Definition (Project & Product information) b) WIP/FG material list c) Project (Client Information) c) Project Personnel

7. Logs (use, cleaning, maintenance)

a) Room Log b) Equipment Log

8. Batch Record

a) MPR Record Definition b) Batch Production Record

9. Audit

a) Audit Log b) Audit Attribute

10. Reports a. Current inventory b. Inventory Value c. Low Inventory Levels d. Inventory in Quarantine e. Equipment CAL/PM Date f. Production Lot Traceability g. Vendor Lot Traceability




Page: 7 of 140

7

There is a set workflow inherent to the program so that the GMP checks and balances can be carried out in real time; thus there is an order in which the training and test scripts must be executed for success. The order generally follows the menu items from top to bottom. Your trainer has access to the DBADM (database administrator) dashboard whereby they can toggle on and off certain features. Specifications may be turned off (Note: this feature is not meant to be turned on and off repeatedly) inventory checks for Material amounts can be turned off Allowance for same user to sign for log and batch record operator and verifier for those not ready for full adherence to GMPs. Abbreviations

Acronym Definition

ADM Role assigned to one personnel place in the system that has access to personnel to begin entering users into the system.

BOM Bill of Materials

BPR Batch Production Record

CoA Certificate of Analysis

FG Finished Good

ID Identification

INV Inventory Manager role

IO Inventory Operator role

IT Information Technology

MPR Master Production Record

MSDS Material Safety Data Sheets

oWIP Outgoing Work In Process

PM Project Manager




Page: 8 of 140

8

PS Production Supervisor

QM Quality Manager

QO Quality Operator role

Req Requisition, Purchase Order (with no associated cost )

WIP Work in Process




Page: 9 of 140

9

Definition Glossary Acceptance Limit: result requirement for passing test. Administrator/ADM: the personnel with only personnel screen permissions in the system in order to get the User names into the system. This user has no signature rights. Approval: Formal permission or sanction needed: signature. Approved: Confirmed or sanctioned formally, by signature. For materials and products: passed all specifications and is fit for use, distribution or sale. Bin Location: location of materials as uniquely defined by further organization than room #/name. Batch size: Amount of a finished batch, to be associated with corresponding unit. BPR: Batch Production Record; the unique and numbered documentation of the manufacture of a specific production run or batch of product. The BPR will have a unique auto-assigned batch (production or lot) number and the capture of weights, times, and other results will be specific to one instance of following the included instructions. There is an option to enter legacy production numbers as well. Client: the person or company who is responsible for funding the project. Close: close the web page without saving changes. Company: Your firm, plant, or company name (as editable on the DBADM dashboard only; this is displayed in the upper right hand corner of the application) Conditional Approval: Confirmed or sanctioned formally, by signature, but with restrictions; permission to use at risk but not to ship, or pending some specified action. Confirm: close the web page with changes saved. DBADM: Data Base Administrator; role in InstantGMP utilized by InstantGMP support specialist to provide customer service and for QA tester to perform U/FAT/OP/OQ testing. Formulation ID: number or name identifying the specific recipe, formula, instructions, product strength, flavor, unit, etc. of a product.




Page: 10 of 140

10

Production Supervisor: the personnel role subordinate to Project Manager who is responsible for overseeing InstantGMP production at the manufacturing site. Product Code (lite): internal code for product. In-Process Test: Testing or inspection of any ingredients or components of a product or WIP during any production phase. Instance: Customer-specific, secure, cloud-based Database of InstantGMP. Instance Owner: the company who has been assigned a specific instance of the InstantGMP data base and who has control of the personnel, materials, facilities, equipment, projects, logs, specifications, inventory, batch records and security settings for that specific instance. Insert: to add new record. Inventory Manager: Role specifically for those who purchase the Inventory version of IGMP with modified permissions to exclude Projects, masters and batch records and includes more rights than an operator. (similar to a PM with QM rights for material handling) Inventory Operator: Role specifically for those who purchase the Inventory version of IGMP with modified permissions to exclude Projects, masters and batch records and includes more rights than an operator. Material: any component, excipient, reagent, active ingredient or drug product that is needed for or manufactured by InstantGMP. Material Type: The Physical form of a material. MPR: Master Production Record, A written template for the recipe and manufacturing instruction steps and other info necessary for completing manufacture product. Operator: the personnel who use InstantGMP to perform warehouse and production activities. Order: drop down which allows users to order the results of a summary screen by any column header. oWIP : Outgoing work in process: Partially processed material that is either held for further processing, sold to a middleman or distributor, etc. treated like a finished good in inventory after processing if added to inv via the button on batch record. Performer: User/operator who completed task.




Page: 11 of 140

11

Personnel: Interchangeable with user, person assigned a name and password in the application. Print: provide a hard copy or PDF copy. Product Name: product to be produced, and for which to write an MPR. Defined in the project by the concatenation of the material name, strength, primary container and suffix. Project: (MES only) precursor to creating an MPR, assigning a WIP or FG part number with additional titles and associating with a client (differentiate the client/sponsors’ MPRs from other projects.) Project Manager: the personnel who have the InstantGMP responsibilities defined in the Project Initiation SOP. They are generally in charge of the project team and administration for manufacturing projects. Production Supervisor: Operations manager at the floor level responsible for Production Operators and Operations including log responsibilities. Quality Manager: the personnel who have the InstantGMP responsibilities defined in the Quality Management SOP. They are generally responsible for quality oversight and approval of quality operations in manufacturing projects. Quality Operator: Role allowing for more permissions than an operator for Quality control analysts. Quarantine: Isolate or put on hold; not for use until further notice, the status all received and batch-created materials default to in InstantGMP. Rejected: Not accepted, not allowed to be used. Requisition: request/order for materials from vendors. Save: to retain. Screen/page name: Developer chosen screen names visible at bottom left of each screen. This differs from the title of the screen which appears across the top left of each screen in large blue lettering. Specification: Set of parameters defining the tests and limits required for acceptance of a material for use in production or for distribution or sale.




Page: 12 of 140

12

Status: Standard state of Quality of a component, excipient, API, raw material, WIP or finished Product; used to assess a material’s safety and conformance to applicable specifications. Standards are Quarantine, Approved, and Rejected. System Type: Status of a material, FG, oWIP, WIP, Raw. Test: name of the test or goal of a procedure. Test Method: Description of how a specific test is performed, standard to follow. Theoretical yield: Amount of product that could theoretically be produced from a recipe in the MPR given no loss (via deviations, testing/samples, QA inspection rejects, normal operation loss e.g. lost in air, residue on equipment, batch does not fill full integer of containers, etc.) Title: User Functional Screen Title visible in Blue font in top left of screen. Update: to modify a record; add, edit or delete. User: The individual with a user ID and password. Verifier: Personnel to sign for verification of a manufacturing step which a performer has completed. Verify: to confirm the truth or correctness of (something). iWIP: Work in process; incoming goods that will be used as ingredients in manufacturing. Icon Glossary

User Name and Role: A drop down in the upper right hand corner of the screen that lists the roles that are currently assigned which user may toggle between.

Note: This feature is for convenience and special circumstances and should be used responsibly and only within the scope of 21CFR part 11.




Page: 13 of 140

13

Title: At the top of the page the screen name indicates what kind of data the system will display in the current screen In the example, the title says "MPR Record Definition"

Direct Access Icons: At the upper-right part of the screen there are, depending on user rights, three active icons:

o Password (change password)

o Favorite

o Home button (resets to see entire menu)

o Security (change user rights to the current screen) , and

o Logout (leave the application)

Pagination Buttons: The information in the grid is displayed in groups of usually 50 records. To access the next 50, there are paging buttons:

The "First" button: , the "Previous" button: , the "Next" button: and the “Last"

button to access the chosen number of records.

The Qty of rows field allows users to adjust the amount of rows displayed on the screen. Enter

the number desired and select the icon.

In some cases there may be an “Add New Record” button, to add new records. The Confirm button registers the entered data into the data base. The Close button closes the screen and returns the user to the previous screen but does not save any changes in the database.

The Search button searches for the entered data. The Clear button clears all data from the search function and resets the screen to include all data.




Page: 14 of 140

14

The print button appears on several pages and allows the user to print an MPR or BPR.

A report for Material Specifications can be printed using the report button.

The “Copy Manufacturing Steps From Another MPR” button allows the user to select from a list of MPRs from which to import the manufacturing steps.

The “Copy Materials From Another MPR” button allows the user to select from a list of MPRs from which to import the materials.

The “Copy Equipment From Another MPR” button allows the user to select from a list of MPRs from which to import the equipment.

The “Copy Tests From Another MPR” button allows the user to select from a list of MPRs from which to import the tests.

The sign button comes in different forms and prompts the pop-up signature box. Performer, Verifier, PM, QM, Approval signatures are all variants of the “sign” button and are seen throughout the program.

The Choose File button allows the user to search for documents on his or her computer to attach to a record. The attachment file Document Name link is available on the records once a file has been attached. Selecting the hyperlink of the file name will prompt pop-up box for user to choose what to do with selected file.

The Add Test button adds a line for tests methods and acceptance limits on the specifications screen.




Page: 15 of 140

15

The sort/filter selector: In the right collapsible search panel there will be an option to organize the data on the grid. This drop down box allows determining how the results will be sorted/filtered

The Show selector is available in the search panel on select screens and filters for and shows only records that fall under the selected status.

Search /Clear: allows the user to search for records or to clear the current filters. There are several possible scenarios regarding the use of the filters:

o If the user needs to find a particular record, s/he types the record name and clicks search.

o If the user does not enter anything at all in the field, then the system will display all available data, with a default of 50 records per page.

o If the user does not remember the complete record name, s/he can enter any part of it and the system will search for all records which include the typed string.

o If there is more than one filter and the user enters data in more than one field, the system will search information that matches ALL filters entered.

The Show drop down: shows only records with status of chosen option The Data Grid: The area where data is displayed. In each line of the grid there may be

two or three controls:

o A hyperlink, indicated by blue text, which takes the user to the record detail.

o An Update pen Icon ( ) which allows the user to modify the record.

o In some cases there may be a version hyperlink; such as for a material or requisition which will also be indicated by blue numbers. E.g.: Version: 2.

o The Copy (MPR versioning) icon can be seen on the MPR summary page and makes a new, editable copy of the closed-out record.

o The version up icon allows user to make a sequentially numbered version of the chosen MPR and can make changes to certain fields.

o The Scale up icon allows users to scale up the theoretical yield which automatically scales up the BOM. If the auto populate button is checked, the scaled up amounts are also transferred to the material action associated with the use of a material on manufacturing instruction steps.

Note: The min and max are not automatically updated and should be checked.




Page: 16 of 140

16

o User-selected data lists will include the choice to update or delete an item. The delete icon will either instantly delete the record to bring up a pop-up screen asking user to confirm the deletion. Select embedded tables have gray x’s for delete buttons.

o A printer icon to the left of completed records can be selected to print specific records.

Data Entry “T” Screens

o Some screens will also include a material upload arrow which prompts a selection list of materials to choose from as a separate pop-up screen. This icon can be seen on MPR and BPR BOM pages, Project Definition, Manufacturing instruction Step, and Requisition screens. These screens are data entry screens whose screen names always begin with “T.”

o Blank checkboxes with dark blue outlines are available on several screens and indicate that they can be selected; for example:

Note that some boxes (gray with gray checks) are visible from other screens, but they can only be modified via screens whose names start with “T.” For example, the HWWMaterialStatus screen shows a list of checkboxes whose statuses can only be changed on the TMaterialStatus page after selecting the update pen icon.

The attachment file selection button appears on the Material receipt, Material status, MPR and BPR cover pages as well as the manufacturing instructions of the MPR and BPR; It allows for the attachment of a word, excel, jpg, or PDF file and is updatable (exceptions to update: after MPR is locked, after receipt has been signed off and confirmed.) This button will allow the user




Page: 17 of 140

17

to open existing attachments on material status, material use, material (bin) location, and MPR and BPR covers.

The calendar icon allows the user to select a date from the calendar rather than write it out. Add Material Requisition button allows users to add lines to the requisition grid.

Change Location button allows users to change the location of a material vendor lot # via the bin location.

The Update button appears on certain pages to allow the user to enter or change data on an existing record.

The unlock function allows a QM user to unlock a previously locked BPR for the purpose of adding memos regarding deviation investigations or adding stability data to an attachment.




Page: 18 of 140

18

The Add Batch Inventory button allows the user to enter the amount of a finished batch produced so that it can be tracked in inventory.

The Inventory button begins the workflow for a user to allocate use of a material in real time during batch production via the batch record manufacturing steps or for more general purposed via the inventory module. Bin location of material can also be accessed. Manufacturing Process Overview There are many QA checks and balances written into the program which guide an organized workflow that follows Good Manufacturing Practices:

Create/UpdateMaster Record

Create/Update Batch Record

(Copy of Master Record)

Enter/Upate Setup

Information

Bill of Materials

Equipment

Mfg Instructions

Approvals

Bill of Materials

Equipment

Mfg Instructions

Approvals

Master RecordApproval

Login

Add Batch to Inventory

Enter Materials Create/Update Specifications

Requisition Material

Manage Inventory

Create/Update Project

Manage Room & Equipment Logs

Starting a New Project The checks and balances make quality a built in process that minimizes deviations and omissions.




Page: 19 of 140

19

EnterMaterial Info

Enter/UpdateSetup

Information

SpecsApproved?

Create/Update Project

System Assigns Part #s,

Enter/UpdateRM/iWiP Specs

No

ProjectManager

Personnel

Vendor

Material Types

Material Status

Unit

StorageConditions

Facility

Equiment

Room

Tests

Methods

Countries

QualityManager

Select FG/oQIP to manufacture

Select Client(s)SpecificationsApproval

Initiate/UpdateProject

ProjectManager

Create Product Name(s)

Assign Personnel and Rolesin Project

Client

SpecsApproved?

Enter/UpdateFG/oQIP Specs

No

QualityManager

SpecificationsApproval

ProjectManager

Ready to Create Master Production

Record

Bin Location

Equipment Type

Reference: SOP-101 Project Initiation Optional features: Some features within InstantGMP are controlled in the background by the DBADM dashboard. Contact your InstantGMP support specialist to toggle these features on and off:

1. QuickBooks Data Transfer tool 2. Ability to include FG and WIPs as ingredients in a Bill of Materials on the MPR. 3. Scanner Integration 4. Automatic Printing of Label on Receipt 5. Inventory Check Off 6. Specs Off (popular for VAPE) 7. Same person allowed on dual signature (popular for VAPE) 8. Medical Device View vs. MES view 9. EU date format vs US date format

Other optional features: 10. Increase user limit (contact [email protected]) 11. Data import spreadsheet allows for import of vendor and material definitions (raw,

WIP and FG names) (visit instantgmp.com or contact support specialist for excel file with instructions.)

12. Integrate scales to import weight data directly into logs, reports and Batch Records. STEP 1. Open your Instance of InstantGMP using your assigned Hyperlink to the secure

web address.

STEP 2. Sign in with your assigned UserID and password or with ADM user ID and password to create a new user.

(This information is provided by InstantGMP support via email)

mailto:[email protected]




Page: 20 of 140

20

Set-Up Adding Personnel

STEP 3. Navigate to: Set-Up menu Personnel Through this option a user shall have the ability to insert, update and search Personnel. The password must follow a medium password strength policy.

STEP 4. Select Update pen for ADM.

STEP 5. Enter your e-mail for ADM.

STEP 6. Confirm.

STEP 7. Select Add New Record button to create a new record.




Page: 21 of 140

21

STEP 8. Enter First and Last Name (Project Manager)

STEP 9. Enter “pass1233” for a medium strength password

STEP 10. Select Project Manager role from the Default Job Function dropdown

STEP 11. The Administrator Rights Permission set is granted by clicking the checkbox




Page: 22 of 140

22

STEP 12. Click

STEP 13. To add badge information click for the person and select a start date of no later than current date and an end date of a year from now. (the badge scanner option must be selected for on the dashboard for the feature to appear)

STEP 14. Repeat these steps for the Quality Manager role

Application Rules:

• First Name and Last Name are mandatory. • Only Administrators and those with AR rights shall have the authority to grant and revoke the

Administration permissions set. Only Project Managers should be designated as users with AR rights. Project Managers should not give Administrative rights to any other roles unless the specific person is trained in the complete application and their project duties include updating administrative information.

• Anyone without the Administrator credentials is prevented from making any changes to screens that are within the Administration menu and its sub-menus.

• User ID is automatically assigned by the program with the following formula: First letter of first name First seven letters of last name Sequential number starting with 01. (if Jane Doe were to be added next, she would be

JDoe02) UserID is not case-sensitive

• A password of medium strength is required; (must include alpha and numeric characters.) • Password is case sensitive. • The default Role can be assigned from the personnel screen. Personnel may login immediately

after role assignment on this screen. • After confirmation of the personnel screen, the option to create a badge is available on the

TPersonnel screen and the option to print the badge is available on the HWW screen.

Vendors STEP 15. Navigate to: Setup Vendor References: POL-0302 Vendor Selection and Qualification, SOP-212 Program to Qualify Vendors Users have the ability to insert, update and search for Vendors. Note: Manufacturer using IMGP must be listed in the vendor table. When FG or WIP materials are to be produced using InstantGMP Batch records, the vendor list is selected from to identify the vendor of that manufactured FG or WIP. Note: The company name entered on the DBADM dashboard will automatically populate as the first vendor.




Page: 23 of 140

23

Note: Information other than Company Name is not mandatory and can be filled in at your leisure

STEP 16. Click

STEP 17. Enter “Training-Great Raw Materials” as a vendor.

STEP 18. Click

Client STEP 19. Navigate to: Setup Client Note: A Client is any company ordering/funding projects, and/or represents clientele for whom your firm does manufacturing, holding, packaging or private labeling. Alternatively, your firm may be a Client who holds/packages/labels WIP/FG from other suppliers whom you are mandated by the FDA to procure MPRs and BPRs from in efforts to trace raw materials to customers and vice versa. There are different ways to set up MPRs depending on your firm’s role in the process. Note: The Company added on the Dashboard is automatically auto assigned as the first Client.

STEP 20. Click




Page: 24 of 140

24

STEP 21. Enter Client Name: Training

STEP 22. Select “United States” from the Country drop down box.

STEP 23. Click

Material Types STEP 24. Navigate to: Setup Material Types References: POL-0303 Material Control Requirements, SOP-302 Material Types

Through this option a user shall have the ability to insert, update and search Material Types.

An effective Material Control system is essential to ensure that material and components are procured, received, approved for use, labeled including expiry date, coded, stored, transported and dispensed according to documented procedures when InstantGMP™ is used.

Note: These names will be the only items available in drop down boxes when material types need to be selected and are essential to optimal organization of materials within InstantGMP.




Page: 25 of 140

25

When new “Material Types” are entered into the system, they must be further classified with a “System Type.” The three “System types” in the system are Raw Material “RM”, Incoming Work in Process “iWIP”/Outgoing Work in Progress “oWIP” or Finished Goods “FG” This will differentiate types of materials in other screens of the application where the system type is not displayed. This will be important for searches for materials in other data base tables. Only “Work in Process” or “Finished Goods” material types will appear when a Part # is needed in the Project Definition screen. Material Types that have a system type of “Work in Process” or ‘Finished Goods” will not be editable. The screen does not have the “update” button available for these types.




Page: 26 of 140

26

STEP 25. Click

STEP 26. Enter “Raw Material” in the Material Type Name field

STEP 27. Select “Raw Material” from the Type drop down box

STEP 28. Click

STEP 29. Click

STEP 30. Enter “Packaging” in the Material Type Name field

STEP 31. Select Raw Material from the Type drop down box

STEP 32. Click and repeat steps for the material types that apply to your operation.

Note: Finished Goods is a preset option and does not need to be entered; however, customization such as “Encapsulated Finished Goods” can be created for convenience. Material Status STEP 33. Navigate to: Setup Material Status References: POL-0303 Material Control Requirements, SOP-304 Material Status

Through this option a user shall have the ability to insert, update and search Material Status. Application Rules:

• The system will always maintain the material statuses "Quarantine", "Approved" and “Rejected” which cannot be deleted.

• The system will allow entry of other material statuses. • If the “System Status” check box is selected, it locks the “Material Status” name which can then

not be updated, changed or deleted. If the checkbox is not checked, the user can update the material status at a later time.

• Anyone with Administrator rights can check the System Status box and lock in a custom name




Page: 27 of 140

27

and Status indicator (Quarantine/Approved.) This ensures that should a custom status be created, it will always be identified to a root Status; e.g. “QA retains; Quarantine” or “Ready for Shipping; Approved.”

Note: “Is Quarantine” is used as a default to define the status when an incoming material is first received or internally produced WIP of FG is logged into the inventory after production. • A Material Status of “Is Quarantine” prevents the material from being used in a production batch. • Only the material types in this screen will appear in drop down boxes for material approvals.

Optional: steps 29 – 36, adding customized Material Statuses.

STEP 34. Click

STEP 35. Enter “FG Retains/Stability” in the Material Status field

STEP 36. Select the “Is Quarantine” checkbox

STEP 37. Click

STEP 38. Click

STEP 39. Enter “Approved for R/D” in the Status field

STEP 40. Check the box for “Is Approved”

STEP 41. Click




Page: 28 of 140

28

Storage Condition STEP 42. Navigate to: Setup Storage Condition Reference: SOP-412 Environmental Chambers and Storage Note: “Storage Conditions” refer to the conditions that are available in the facility covered by an instance of the data base. Only the storage conditions in this screen will appear in drop down boxes when storage conditions have to be specified.

Through this option a user has the ability to insert, update and search Storage Conditions. If there are stability chambers, cold rooms and warehouses, each condition should be entered. The Storage Condition Name is a unique and required field.

STEP 43. Click for the “Ambient” selection.

STEP 44. If your facility has specifications for ambient room temperature such as: 18 C 45%RH, or 68-73 F, 44% RH, enter it here. If not, make no changes.

STEP 45. Click

Unit STEP 46. Navigate to: Setup Unit




Page: 29 of 140

29

“Unit” refers to units of measure that will be used in the purchasing of materials and in creating batch formulas. The unit conversion feature enables the operators to purchase material in larger quantities (e.g.: kg) and deplete the inventory in smaller quantities (e.g.: g). Application Rules: • Only the units in this screen will appear in drop down boxes when units have to be specified. • Additional static units may be added by selecting the insert button and confirming a new

entry. These units will not be interchangeable nor will they convert from or to any other unit.

• The Unit Name is a unique and required field. (this only applies to additionally added units, which for most companies is not necessary.)




Page: 30 of 140

30

Facility STEP 47. Navigate to: Setup Facility Reference: SOP-404.01 Facility Start-Up and Shut-Down, SOP-401.01 Performance Qualification of Systems (PQ), SOP-402.01 Facility Access and Security, SOP-403.01 Warehouse and Production Area Cleaning and Maintenance. “Facility” refers to the buildings/Campuses where manufacturing/holding/packaging is to be tracked in a single instance of InstantGMP software system. Through this option a user has the ability to insert, update and search Facilities. System Rules:

• Only the facilities entered on this screen will appear in drop down boxes for specifying facilities.

• The Facility Name is a unique field.

STEP 48. Click

STEP 49. Enter Facility name “Training-Manufacturing Site”

STEP 50. Click

Room STEP 51. Navigate to: Setup Room References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-406.01 Equipment and Room Logs and Status Tagging Through this option a user shall have the ability to insert, edit and search Rooms. Room refers to any numbered room or designated space used for storage/holding, processing or packaging of materials and components, as well as any spaces used to support or facilitate those functions or processes documented in InstantGMP. (e.g. weigh room, airlock, gowning room, controlled hallways, etc.)




Page: 31 of 140

31

Application Rules: • Only the rooms entered via this screen will appear in drop down boxes when rooms have

to be specified. • Every Room must be linked to a Facility. This is implemented via mandatory selection of

a Facility from a drop-down box to define a room. • Room number must be unique per facility. Room names can be used multiple times.

STEP 52. Click

STEP 53. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 54. Enter the room number 99900 and room name Z -Training

STEP 55. Click

Bin Location STEP 56. Navigate to: Setup Bin Location References: SOP: 420 Facility Maintenance and Modifications Application Rules: Facility must be unique and is required.

STEP 57. Click STEP 58. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 59. Select “99900-Z -Training”

STEP 60. Enter “102” for Bin Number

STEP 61. Enter “Samples” for Bin Location

STEP 62. Click




Page: 32 of 140

32

Equipment STEP 63. Navigate to: Setup Equipment References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-406.01 Equipment and Room Logs and Status Tagging

Through this option a user has the ability to insert, edit and search Equipment. The Equipment Code is a unique field entered by the user.

Application Rules: • Only the equipment in this list will appear in drop down boxes when equipment has to be specified. • Equipment name and number are mandatory

STEP 64. Click STEP 65. Enter in Equipment Number “999999” and Equipment Name “Training - Equip”

(required fields.) Add arbitrary numbers to model and serial number. Select calendar and current date for due dates.

STEP 66. Click




Page: 33 of 140

33

Tests STEP 67. Navigate to: Setup Tests

Reference: SOP-215.00 Tests “Tests” are the titles of the attributes, quantitative or qualitative, that will be used to determine whether materials in question are in compliance with specifications. A Test names what is being tested for. Application Rules: • Through this option a user shall have the ability to insert, update and search Tests. • Only the tests entered in this screen will appear in drop down boxes when tests have to be specified. • The Test Name is a unique field.

STEP 68. Click

STEP 69. Enter “Micro”




Page: 34 of 140

34

STEP 70. Click

STEP 71. Repeat steps for more tests if applicable to your operation

Methods STEP 72. Navigate to: Setup Methods Reference: SOP-216.00 Methods Application Rules:

• “Methods” are the actual procedures that will be used when testing of materials is required to show the materials are in compliance with specifications. A method is How to test.

• Through this option a user shall have the ability to insert, update and search Methods. • Only the methods confirmed via this screen will appear in drop down boxes when

methods have to be specified • The Method Name is a unique field.

STEP 73. Click

STEP 74. Enter Method associated with a test. “USP (62)” Note: a specific SOP #, procedure #, or Assay name could be used here as well.




Page: 35 of 140

35

STEP 75. Click

STEP 76. Repeat steps for more Methods that are applicable to your operation

Countries STEP 77. Navigate to: Setup Countries

“Countries” identify locations where manufacturing/holding/packaging/labeling facilities are located or where personnel are based. Application Rules:

• Only the countries in this screen will appear in drop down boxes when countries have to be specified.

• Through this option a user shall have the ability to insert, update and search Countries. • The Country Name is a unique and required field.

STEP 78. Click

STEP 79. Enter Country name. “UK”

STEP 80. Click




Page: 36 of 140

36




Page: 37 of 140

37

Material STEP 81. Navigate to: Materials

References: S308 Part # Assignment and POL-0208 Project Initiation Through this option a user has the ability to insert, update, and search Materials. “Materials” are parts and components for manufacturing or the products of manufacturing. Material Classifications separate these two types of materials for ease and organization: Incoming raw materials, components, packaging and labelling and incoming WIPs Vs. Outgoing WIPs and finished Goods (in house WIP counts as outgoing since it is manufactured Note: The components, excipients, raw materials, incoming and outgoing work in processes and finished goods WIPs are materials that are either ordered for further use in production, precursors to products to be manufactured in-house or shipped to be further processed elsewhere. Example: bulk powder herbal blends are FG for the blend manufacturer but are Raw Material for the encapsulator. For the encapsulator, bulk capsules are WIP if packaging is done in-house or FG if sent to a third party. Application Rules:

• Materials should only be ordered from approved/qualified vendors; see business rules on Vendor Qualification. Note: InstantGMP and applicable SOPs assume that all materials ordered are from qualified vendors according to SOP-0212 – Program to Qualify Vendors.

• The Part Number is a read-only and auto-numbered field assigned by the application • Material Name is a unique field. An error message will be displayed if a duplicate is

entered. • Products to be manufactured are automatically assigned Part #’s by the system prior to

production so these materials can be tracked by the system prior to and after manufacturing.

• Material Classification, Material Name, Type, Unit and Storage Condition are required fields.

• The Material Name will be a read only field after it is created. • In the Material Update screen shown below, the Material name cannot be edited. • Vendor number is akin to a catalogue number from a vendor; individual lot numbers are

entered later.




Page: 38 of 140

38

• The application will alert user with red error messages when any mandatory field has been overlooked.

• The selected Unit for outgoing materials should represent the Material units required when creating the batch.

o Note: Take time to consider ordering unit, densities used in any calculations and unit of sale item. This is a crucial step of the organizational process that can save you consulting hours in the long run.

The search panel on the right includes a search for part #, material name, material ID and a filter for Material type.

STEP 82. Click

STEP 83. Select “Raw Material/In-Coming WIP/Other” Material Classification

STEP 84. Click




Page: 39 of 140

39

STEP 85. (Mandatory) Select the (Material Type) “Ingredient-RM” (See Figure 21)

STEP 86. (Mandatory) Enter the Material Name “Training-Raw Powder”

STEP 87. (Mandatory) Select the unit of measure associated with the material. “g”

STEP 88. Enter the Material ID “Training Raw 1”

STEP 89. Enter the Material Description “Fine white powder”

STEP 90. (Mandatory) Select Storage conditions from the dropdown box. “Ambient”

STEP 91. Enter a shelf life (based on stability studies, the limiting ingredients’ expiration date or a default standard) “12 months”

STEP 92. Enter QM retest period (based on QA retain or stability test specifications) “12.000”

STEP 93. Enter a vendor order number if known (static number used from a supplier to represent that material): “TrainingGRM-1”

STEP 94. Select Vendor from the dropdown box. “Training-Great Raw Materials” (Select your own company for products produced or packaged in-house)

STEP 95. Click

STEP 96. Repeat steps 81 through 91 for “Training-Capsules” (See Figure 21)

STEP 97. Repeat steps 81 through 91 for “Training-Container” (See Figure 21)

STEP 98. Repeat steps 81 through 91 for “Finished Encapsulated Product FG” (See Figure 21)




Page: 40 of 140

40

Note: For this material’s Select Material Classification Use “Finished Good/Outgoing WIP”

Material Type Ingredient-RM Component-RM Primary Container-RM

Packaged/Labeled-FG

Material Name Training-Raw Powder

Training- Capsules

Training-Container

Finished Encapsulated Product FG

Unit g ea ea kg Material ID Training Raw 1 Training Raw 2 Training PC Training Finish Material Description

Fine white powder Clear, no band vegetarian gel

White plastic bottle

Encapsulated Powder

Storage Condition

Ambient Ambient Ambient Ambient

Recommended Shelf Life

12 months 12 months 120 months 12 months

QM Retest Period

12 3 12 3

Vendor Order Number

TrainingGRM-1 TrainingGRM-2 TrainingHDPE

Vendor Training Great Raw Materials

Training Great Raw Materials


Figure 21 Note: Confirmation will return user to the HWWMaterial screen with a summary of all materials confirmed.

Material Specifications Specifications for Raw materials including any components, labels, etc. or incoming WIPs may be any tests completed to prove the purity, strength, identity or general physical properties and fitness for use in production. This also includes any visual comparison to a known standard as well as other organoleptic methods. Specifications for outgoing WIPs and FGs produced in-house may also have specifications for final purity and strength, retain and stability testing and in-process testing such as fill volumes or weights of capsules, pH, uniformity of color or viscosity, inspection of containers, closures, packaging and labelling, among others.




Page: 41 of 140

41

STEP 99. Navigate to: Specification

The Material Specifications page “HWWSpecification” screen shows all specifications, allowing for filtering for “Approved,” “Pending Approval” and “All.”

Application Rules:

• The record is automatically assigned a sequential version number. • A user has the capability to insert, update and delete tests/methods/etc. for a Material

Specification until both the PM and the QA signatures are confirmed. No further changes can be made after the PM and QM approvals are confirmed.

• Part #s with an update icon indicate that the material specifications have not yet been approved and locked.

• A version 2 cannot be created until the version 1 signatures have been confirmed. (A part # whose specification is open (not locked) will not appear on the “Select Part # to version Up” screen (and a new specification version cannot be created) because the prior version has not yet been approved and is still editable.) Open records will only appear on the HWWMaterialspecification screen and can be seen by filtering for “pending approval” or “ALL”

• QM and PM approval is necessary for the Material to be used in the Bill of Materials of an MPR, inventory, or projects.

• If a material needs different specifications for different uses (e.g. lactose in a liquid product vs. lactose in a powder product), a new material part number must be created and assigned unique specifications.

• Different versions of a material specification may be used concurrently in different MPRs




Page: 42 of 140

42

This list is comprised of materials with specifications still pending one or more signatures and materials for which specifications are completed and locked down. Note: if you expected to see records on this screen but do not, select filter in the right collapsible panel, for “ALL” to display those records.

STEP 100. Click to create new specification.




Page: 43 of 140

43

This list is comprised of new materials without specs assigned and materials with signed off specs for which a new specification record can be generated. If a material does not appear on this list, the material has an open record that needs to be edited and/or signed. To access open records, select the “Cancel” button to return to the hub screen and filter for “Pending Approval” or “All.” Records with update arrows can be modified and signed and locked.

STEP 101. To create version 1, Click the for the “Training-Raw Powder” Material.

Note: Even if no data is entered, confirming creation of this record will move the record to the HWWSpecifications screen for in process records awaiting approval.




Page: 44 of 140

44

STEP 102. Enter the effective date or current date of the test specifications for the material.

STEP 103. Enter the MSDS/ Safety and Handling Data “Wear gloves and mask; handle and store in cool dry environment”

STEP 104. Enter General Sampling instructions for the material “Use plastic scoop #3 to aliquot 5 grams into each of three plastic sample jars. Secure lid and label”

STEP 105. Click Add test button

STEP 106. Select test “Micro” from drop down.

STEP 107. Select Method “USP <62>” from drop down.

STEP 108. Enter a Acceptance limit of “<0 CFU”

STEP 109. Enter a Sampling of “In Process Visual”

STEP 110. Select the box for Required for Release

Note: The box for release indicates that the test in question is required to meet specs before the material or product is released for R&D, production use, distribution or sale.

STEP 111. Click

STEP 112. Log out

STEP 113. Login as PManager01

STEP 114. Select Signature prompt for Project Manager/Project Supervisor

STEP 115. Click

STEP 116. Log out

STEP 117. Log in as QManager01

STEP 118. Select Signature prompt for Quality Manager

STEP 119. Click




Page: 45 of 140

45

STEP 120. Repeat steps for the remaining material part #s in order to set and approve

specifications for all materials needed for production including the finished good product:

Material Name Training - Capsules Training-Container Finished Encapsulated Product FG

Effective Date Use current date Use current date Use current date Safety/Handling Don gloves, keep cool

and dry Don gloves, keep cool and dry

Don gloves, keep cool and dry

Sample Instructions Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

Clean dry scoop/Close and label with lot#, personnel initials and date/see methods.

tests Select a test and method from drop down

Select a test and method from drop down

Select a test and method from drop down

STEP 121.

Note: A New sequential version (2) may be created by clicking the hyperlink for part number on the version up screen and repeating steps for a part number with an approved specification version 1. Reason for change is required.

Creating a Project Application Rules:

• Your firm should be entered as a Client as well as a Vendor; this may be accomplished in one step by having your support specialist (the DBADM) enter your company into the “Company” field on the DataBaseADMinistrator dashboard.

Project Definition STEP 122. Navigate to: Project




Page: 46 of 140

46

STEP 123. Click

Application Rules:

• The Project Title is a unique and required field. • The Project Title is read only once the Project is created. • Only parts that are “oWIP” or “Finished Goods” can be selected in the Part Number field. • Multiple part numbers may be selected for a single project.




Page: 47 of 140

47

• Multiple products built on the same part number are allowed per project STEP 124. Enter the Project Title “Training -Finished Encapsulated Product”

STEP 125. Enter a Project description (optional)

STEP 126. Select WIP/FG Part # Tab

STEP 127. Click




Page: 48 of 140

48

STEP 128. Click for “Training - Finished Encapsulated Product FG”




Page: 49 of 140

49

STEP 129. Enter Strength

STEP 130. Click for the Primary Container part # selection list




Page: 50 of 140

50

STEP 131. Select the hyperlink for the Primary container

STEP 132. Enter a Product Name Suffix (optional)

STEP 133. Click

STEP 134. Select the Client tab

STEP 135. Add secondary client if applicable

STEP 136. Select the Personnel tab




Page: 51 of 140

51

Note: Delete personnel from the project or add personnel to the project using

button

STEP 137. Click to add a secondary role for the PM

Application Rules: • Each person must be assigned a Job Function in order to log into the application. (Until a

primary role is assigned on the TPersonnel screen,, the application has no permission boundaries set for that person; the default is no permission set and the person cannot get to the main menu) See Personnel page for other options.

• Personnel can be assigned different roles for different projects. • Personnel can be assigned multiple roles per project. • A person can be an MPR Approver and/or a BPR Approver, or neither. • Each Project should have at least one MPR and at least one BPR approver assigned.

STEP 138. Click




Page: 52 of 140

52

STEP 139. Select Quality Manager role from the drop down

STEP 140. Click

STEP 141. Select update icon for PManager01

STEP 142. Select the MPR and BPR checkboxes

STEP 143. Click




Page: 53 of 140

53

Requisitions

STEP 144. Navigate to: Requisitions

Through this option a user can create a material requisition with multiple materials from the same vendor. Application Rules:

• The system will allow a user to build a requisition using materials from a single vendor. • One and only one vendor is identified per requisition. • Only approved Material Specification versions will appear in selection list • The Part Number, Unit, and Qty fields are required fields for each line of the requisition. • Unit chosen must be equivalent to or convertible to the unit assigned to part # on Material

page • Amounts ordered for a material requisition can be converted to other units within that

unit system but cannot be converted from weight to volume or vice versa. • The system will assign a unique requisition number for each requisition created. • Once a Requisition is signed and confirmed it cannot be edited. The system will display a

print icon yielding a PDF version of the requisition • No update icon will be displayed when the record is no longer editable.

STEP 145. Click

STEP 146. Select the Vendor “Training-Great Raw Materials”




Page: 54 of 140

54

STEP 147. Select needed by date (Today’s date)

STEP 148. Click

The Select Material Specification pop up will appear

STEP 149. Select “Training - Raw Powder” (popup is closed automatically

STEP 150. Enter Qty “3.010”

STEP 151. Select the unit kg from the unit drop down box.

If not already present, Enter “TrainingGRM-1” in the Vendor Order Number field. STEP 152. Make sure to check the boxes for MSDS and COA. (Material Safety Data Sheets

and Certificate of Analysis)

STEP 153. Click

Repeat steps 142 through 147 for Vegetarian Capsules as seen below:

STEP 154. Click at the bottom of the page

STEP 155. Enter credentials and confirm.

STEP 156. Click

Vendor Material Name Unit Quantity Vendor Part Training Great Raw Materials

Training Raw Powder

kg 3.010 Training-GRM-1




Page: 55 of 140

55


Training Capsules - Vegetarian

ea 1000 Training -GRM-2


Primary container

ea 100 TrainingHDPE

STEP 157. Select the printer icon on the requisition screen.

STEP 158. Print and or email electronic copy of the Requisition Order to Project Manager. (Functionality will depend on version of Adobe)

Regardless of the accompanying software, the printout will appear as below:




Page: 56 of 140

56

Inventory This module includes Receipt, Status update and Use of a material. Material Receipt

STEP 159. Navigate to: Inventory Material Receipt

Application Rules: • For each line (Part #/Material) of a requisition order, the system shall create a unique

Receipt Number for each material received per requisition which is auto-numbered and read-only. This number is created at the time of requisition confirmation.

• A digital signature is required to save a material receipt record. • The system will allow a user to record the receipt of a specified quantity of material,

which is added to the inventory upon confirmation of signature. • • The system will allow a user to search for a material based on either Part Number,

Receipt Number, requisition number or material name. • The system will allow a user to record inventory usage details for each receipt number in

the system. • Through this option a user can search all the material that was ordered and ready to be

received as well as any partial records awaiting signature confirmation.




Page: 57 of 140

57

STEP 160. Click for a part number to receive

STEP 161. Select the MSDS and COA checkboxes indicating that the data was received.




Page: 58 of 140

58




Page: 59 of 140

59

STEP 162. Enter the Qty received 3.010

STEP 163. Select the unit received

STEP 164. Enter Vendor lot # “Training 2,” representing the specific lot received.

STEP 165. Select calendar icon and select today’s date for date received.

STEP 166. Select calendar icon for “Use by” date; select one year from now by selecting double arrow icon and selecting date.

STEP 167. Attach any COAs or MSDSs via the “Choose File” buttons.

STEP 168. Click

STEP 169. Enter credentials

STEP 170. Click

STEP 171. Repeat steps for the remaining part number receipt Vegetarian Capsules.

Vegetarian Capsules Primary Container Qty Rcv 1000 100 Units ea ea Vendor Lot Number Training-GRM 2 TrainingHDPE Date Received Use current date Use current date

Use By One year from current date

One year from current date

Application Rules:

• Qty received, date received and vendor lot number are required fields • Upon confirmation of a material receipt record, that receipt# is no longer available on the

receipt screen • Upon confirmation of a material receipt, the record becomes available in the Material

Status section with a default status of “Quarantine” and on the Material use screen. Inventory Status STEP 172. Navigate to: Inventory Inventory Status

Application Rules:




Page: 60 of 140

60

• Only a Quality Manager (or inventory manager in the INV system) can change the status of received inventory.

• Any updates require a digital signature and will always display the UserID/time/date stamp from the latest confirmed update.

• The default value for all materials is Quarantine. The Inventory Status screenshot shows the record created for a material received.

STEP 173. Select the Receipt number hyperlink

STEP 174. Logout and log back in as a QM OR toggle to the QM role in the upper right hand

corner of the application.

STEP 175. Click

STEP 176. Expand the Status drop down box and select Approved




Page: 61 of 140

61

STEP 177. You will be redirect to a page to enter credentials and confirm




Page: 62 of 140

62

STEP 178. Write “Training- All tests passed, see attachment” in the comment field

STEP 179. Select the browse button and attach a document to represent test results.

Note: the hyperlinked file names can be selected to bring up an open/save window for the previously attached document.

STEP 180. Click

STEP 181. Repeat steps for Vegetarian Capsules and Primary Container.

Inventory Management STEP 182. Navigate to: Inventory Inventory Management

Application Rules • Once a material is received in Material Receipt, the received quantity is populated in the

Quantity Rcv field expressed in units from receipt screen. • Qty remain will be expressed in units from the Tmaterial screen • A record will be created for each Material received in Material Receipt • A quantity greater than zero must be entered.. • A user shall have the capability to remove/deduct (edit) material amount from each

Material Receipt Line with Quantity available. • The system will display the history of inventory usage records and the inventory balance

for each receipt number. • The system will allow a user to enter an inventory usage record using convertible units

(i.e.: g/mg; mL/L) and properly record the inventory balance in the default unit for that receipt.The Project Manager will need to reconcile the inventory manually if multiple sub-shipments of a material with the same lot number are received in the same day. If a material is received on a single receipt with multiple sub-lots with different lot numbers (split lots), then the Project Manager will have to create another requisition and a subsequent receipt for each of the sub-lots.




Page: 63 of 140

63

STEP 183. Select the receipt number hyperlink for a part number.

STEP 184. Click




Page: 64 of 140

64

STEP 185. Enter “1.0” in the Quantity Used field

STEP 186. Select “g” from the Unit drop down box

STEP 187. Enter “Training Exercise- Testing” in the Purpose box




Page: 65 of 140

65

STEP 188. Click

STEP 189. Enter credentials and confirm

Optional: Select gray attachment button or attach another document.

STEP 190. Click

Inventory Location Inventory Location allows users to assign and change the location of an entire material receipt’s vendor lot#/material/amount/unit via the bin location tied to a facility and room. STEP 191. Click receipt hyperlink for material

STEP 192. Click




Page: 66 of 140

66

STEP 193. Select the Facility, Room and Bin Location from the drop downs

STEP 194. Sign and Confirm

Depleted Inventory STEP 195. Navigate to: Inventory Depleted Inventory




Page: 67 of 140

67

Application Rules • Materials with a 0 balance will be in this list. • The page is Read Only. • Through this option a user can view, order and search all the Material Receipt lines with

no Quantity available.

STEP 196. Navigate to: Logs Room Log

Through this option a user shall have the ability to insert, update and view the log entries of the Rooms and Equipment defined on the corresponding Administration screens.

Note: The room name can be a number.

STEP 197. Select Room # hyperlink for Facility

STEP 198. Click Enter:

Facility Training - Manufacturing Site Room Name Z - Training Activity Room Cleaning Cleaning Agent, Lot # Alcohol solution, Lot #222 Prod Name or Part # n/a Batch n/a Temperature 18 C Relative Humidity 45% Comments Room cleaned according to SOP CLN-002

Note: Temperature and humidity are only relevant if the room is supposed to be controlled.




Page: 68 of 140

68

STEP 199. Select Operator Sign button, enter credentials and confirm.

STEP 200. Sign in as a QM

STEP 201. Select Review signature button, enter credentials and confirm.

STEP 202. Click

STEP 203. Navigate to: Logs Equipment Log

Equipment Log screen:




Page: 69 of 140

69

Note: Start Date, End Date, Cleaning Agent, Product Name or Part # and batch refer to the previous batch run in the equipment unless the cleaning is a periodic cleaning or not associated with a batch. This is controlled by your facility’s SOPs. Note: Equipment numbering convention to consider: YYY-XXX where YYY is the alphabetic acronym for the equipment and XXX is the sequential number of that type of equipment for that specific item.

STEP 204. Select Hyperlink for Equipment number

STEP 205. Click

STEP 206. Enter data as shown below:

Equipment Number a Equipment x Activity Calibration Start Date/Time Use current date and time End Date/Time Add 4 hours to above Cleaning Agent, Lot # n/a Prod Name or Part # n/a Batch n/a Comments Equipment calibrated according to Equipment SOP




Page: 70 of 140

70

STEP 207. Have an Operator and Project Manager each sign for the activity.

STEP 208. Click




Page: 71 of 140

71

Master Batch Records

STEP 209. Navigate to: Batch Record -Master Production Record

Through this option a user can add, edit, view, search, sort and hide, copy, version up, scale up and print Master Production Records or Master Device Records. New Print icons are available on the Summary screen:




Page: 72 of 140

72

To use the new Hide function, select the checkbox for those records you want hidden and confirm. To see those records, select “Hidden” from the search Status drop down as search. To see only active records select “Active.” “All” displays all records.

Application Rules:

• Project Title, Product name, Client, Author, Formulation ID, and Theoretical Batch Yield and Unit are mandatory

• The Product Name is tied to the project title and is a concatenation of Product name, strength, primary container and suffix.

• Bill of Materials, Equipment, In-Process tests, and manufacturing instructions are all editable via the MPR tabs until a record is locked down

• is used to edit a record




Page: 73 of 140

73

• is used to delete a record • Approvers are assigned responsibility of approving MPR records via checkboxes on the

Project Personnel page and must sign for an MPR in order to create Batch Records from the MPR.

• Approvers can be edited via the Project Personnel Tab under projects • Upon confirmation of first assigned MPR approvers’ signature for MPR approval, the

record is locked down • Another required approver may unlock an MPR to make edits, at which point the first

signatory must sign again for the new changes. Note: if only one signatory is assigned, the first approval locks the record for good.

• Only one signature for reject will reject and lock the batch • A new version and/or a copy of the rejected batch may be created • An MPR, including attachments, will be read-only once all assigned MPR Approvers

approve the record. • Each MPR can have multiple versions.

• MPR versioning is controlled by signatures and a version button ; a version must have the same Project title, product name, formulation ID, Theoretical Batch size, strength (if applicable) primary container (if applicable) and BOM list amounts and units.

• A Copy of an MPR must begin with a change in one or more of the following fields: project title, product name, client, formulation ID, and Theoretical Batch yield. Note: Instead of copyin a record, users may create a new record from scratch and then copy information from each tab separately. This allows users to copy equipment from one MPR and manufacturing steps from another record, for example.

• Once an MPR or version copy has been created, it cannot be deleted but may be hidden. • In order to use the scale up functionality , the MPR used as a template must

have had the “Auto populate BOM Qty on Mfg. instructions” checkbox checked. • The “Auto populate BOM Qty on Mfg. instructions” checkbox can only be used to auto

populate the BOM quantities on the manufacturing instruction “Actions” when each material in the BOM is used in the batch and the entire amount/unit Qty designated on the BOM is used in one step. Note: according to the FDA, An MPR is a Master template for Batch Records; a batch record must be created for each and every time the recipe/instructions detailed in the MPR are followed for batch production. The scale up feature will scale up/adjust the material amounts on the BOM The scale up feature will scale up/adjust the material amounts on the Manufacturing instructions but NOT the min and max values, as the system does not assume that doubling the amount would double the parameters.




Page: 74 of 140

74

• Theoretical Batch yield is a read-only display of the theoretical yield as shown on the cover page. This will be updated when the scale up calculator is used.

• Users have the capability to select materials to be used. • For each chosen material, a unit must be chosen. • Changes can be made until MPR is approved and locked or rejected. • The “Quantity Required” refers to the amount of each part# that will be staged for

production. This can include components, filters, bottles, capsules, caps, packaging labels, etc.

• “Composition” refers to the amount of material that will be within a set unit of the final product when manufacturing is completed. (e.g. mg/mL, mg/capsule, g/serving, etc.)

• Copy materials from another MPR button allows user to select MPR from which to copy all materials amounts and units.

• Delete all button deletes all records on that screen including those not copied from another MPR.

• “MPR #” automatically assigned to Master record and displayed on the summary screens for MPRs and BPRs for uniqueness and traceability

•

Master Record Cover Page

STEP 210. Click

STEP 211. Select Project Title: “Training-Finished Encapsulated Product” from dropdown menu.

Note: Version will auto-populate upon confirmation of page.




Page: 75 of 140

75

STEP 212. Enter the following information:

Project name* Training-Finished Encapsulated Product Product Name* Finished Encapsulated Product FG- Client* NEW Author* Project Manager Formulation ID* Dry Run Product Strength** 14 Theoretical batch yield*

1002

Batch Size 1000 BPR Unit * kg Primary Container** Amount/Primary Container

Primary Container

Amount Unit g # of Containers 10 Purpose Training Supplement, Digestive health Scope Dry Run Attachment select “Browse” button and select an excel, word, PDF or jpeg file




Page: 76 of 140

76

• * required • ** populated with product name if identified during product name

STEP 213. Click

Master Record: Bill of Materials STEP 214. Navigate to: Materials (Bill of Materials Tab)




Page: 77 of 140

77

STEP 215. Click

STEP 216. Click to select a material

STEP 217. Select part # hyperlink for “Training-Raw Powder” for version 1 from list




Page: 78 of 140

78

STEP 218. Enter data from table below into fields:




Page: 79 of 140

79

STEP 219. Click

STEP 220. Repeat steps for Vegetarian Capsules, Primary Container

Material/Part#

Training Raw Material

Training Vegetarian Capsules

Primary Container

Quantity Required

3 1000 100

Unit kg ea ea Composition 3 1 3 Comp. Unit g ea ea

The Copy Manufacturing Instructions button allows users to copy BOM materials amounts and units from selected MPR. Master Record Equipment STEP 221. Navigate to: Master Production Record Equipment

Application Rules: • Users have the capability to add delete and copy equipment to be used. • Changes can be made until the MPR is approved or rejected.

STEP 222. Click




Page: 80 of 140

80

STEP 223. Select x(a) from drop down box

STEP 224. Click

STEP 225. Optional: repeat for Scale or other equipment entered from drop down

Master Records In-Process Tests STEP 226. Navigate to Master Production Record In Process Tests

Note: these steps may alternatively be integrated into the manufacturing instruction steps.

STEP 227.

Application Rules:

• Users have the capability to add, copy and delete in-process tests that must be performed during batch production.

• Test and Method fields are required fields. • Changes can be made until MPR is approved.

STEP 228. Click




Page: 81 of 140

81

STEP 229. Enter 1.00 for test number

STEP 230. Select “Micro” from the Tests drop down

STEP 231. Select “USP (62)” from the Method drop down

STEP 232. Enter “Check for defects” in the Test Purpose field

STEP 233. Enter “<5% failure per batch” in the Test Specification field

STEP 234. Click

Master Production Record Manufacturing Instructions STEP 235. Navigate to: Master Production Record Manufacturing Instructions




Page: 82 of 140

82

Definitions for Manufacturing Instruction Screens: • Step Number: numerical identification manually assigned to a manufacturing instruction

so that the system can sequentially order the instruction steps. • Part # upload arrow: If a component or material is to be used for completion of a step, it

can be added by using the prompt arrow to display the Part # selection screen • Version #: the version number of the required Part # has to be selected to assure the

material with the proper specifications is used. • Inventory: If a material is to be used in this step, select the “Inventory” check box. This

will alert the operator during batch manufacturing to enter the amount of material that is used at that step and this will decrement the amount from inventory in real time.

• Performer: If a signature of the activity performer is required at this step, select the check box.

• Verifier: If a signature of a verifier is required at this step, select the check box • Material Action: shows action as “Measure (amount/unit/) of (material name)” (smart

field updated with scale up if auto pop check is selected) • Action: the instructions for operators to follow in order to complete the step • Range: If an activity requires a measurement, then a range of acceptable values can be

entered. • Target: (smart field updated with scale up if auto pop check is selected) an activity

requires a measurement, then a target value can be entered. • Min: (smart field) numerical entry for the minimum allowable Qty for step with material.

(associated with Unit) • Max: (smart field) numerical entry for the maximum allowable Qty for step with

material. (associated with Unit) • Unit: Unit of measure tied to the Target and Range, Min and Max. • Attachment: word, excel, PDF, jpeg file attachment e.g. SOPs, device spec drawings,

spreadsheet formulas, forms, links to videos, COAs for material lot used, workflow diagrams, pictures of machinery, etc.

Application Rules for MPR Manufacturing Instructions:

• MPR Version is a read-only field. • Steps will be sequentially ordered (ascending) • Part number upload arrow displays a material selection list based on the MPRs Bill of

Materials. • If Performer and Verifier checkboxes are checked in the MPR manufacturing step, then

those same boxes will automatically populate in the BPR, prompting mandatory digital signatures.

• If the inventory checkbox is checked in the MPR manufacturing step, then that same box will automatically populate in the BPR, allowing the user to deplete an amount in inventory Associated with that step.

• If the Auto populate BOM QTY on Mfg. Instructions is checked on an MPR cover,




Page: 83 of 140

83

o The BOM amounts and associated units will populate actions on the instruction steps.

o The approvals tab will display error messages when material part #s included on the BOM are not included in a manufacturing instruction step.

o The approvals tab will display error messages when material part #s included on the manufacturing instruction step(s) are not included BOM.

o The approval tab will display error messages for any materials in the BOM that were identified in more than none manufacturing instruction step.

o The MPR manufacturing instruction steps will display error messages if the target defined in the BOM is not within range of the min and max entries.

• Data that is not confirmed will be lost. Always confirm data in fields before navigating via hyperlink or button to other functions.

STEP 236. Click




Page: 84 of 140

84

STEP 237. Enter “PREP” in the Action field STEP 238. Select the “---” for the Unit dropdown

STEP 239. Click (Step will be labeled “0”)

STEP 240. Click STEP 241. Enter data as below:

Step 10 Unit “---” Action “Check room log for

cleaning of prep room according to SOP-CLN-xxx”




Page: 85 of 140

85

STEP 242. Click

STEP 243. Click STEP 244. Enter 20 for the step number Note: it is best to leave numerical leeway between steps for possible additions during editing or in later versions of the MPR

STEP 245. Select the upload arrow

STEP 246. Select “Training-Raw Powder” from the Selection list (version # auto-

populates) STEP 247. Select checkboxes for Inventory, Performer and Verifier Note: If the Auto populate Qty on BOM to Mfg. instructions was chosen on the cover page, an action will appear automatically instructing the operator to “Measure out Qty/unit of material part#” STEP 248. Enter data as shown:




Page: 86 of 140

86

Action Tare scale. Record Scale Equip # and Calibration date.

Min .99 Max 1.2 Target 1.0 Range .99-1.2 Unit kg

STEP 249. Click

For Training purposes two steps are sufficient; however, if more practice is needed, one can certainly use the examples below to create multiple steps and signature sets. Bear in mind that each of the signature boxes checked must be signed for at the batch record level. Manufacturing steps to consider for a GMP MPR include:

• Counting and verifying labels – expiration date, product name, country of origin, dosage or recommended scope, any mandated info (e.g. for dietary supplements signifying product is a Dietary Supplement; not intended to cure treat or prevent disease; not endorsed by FDA)

• Checking Cleaning room logs, • Checking equipment cleaning logs and calibration dates • Obtaining line clearance from QC (environmental testing) or operators (debris and last-

batch labels cleared away/cleaning) • Staging materials (checking statuses, writing lot numbers and expiration dates, moving to

weigh station, cleaning, prepping utensils and bags/bowls) • Calibrating, tare weights, calibration dates of Scales/ recording • Turning on filters, air controls, water skids, machinery • Individual steps for operators to follow in order to run any of the machinery

o Time to do so o Speed/level/

• Gowning/Donning PPE safety equipment – gloves, respirator, booties, hairnets etc. • Weighing – actual weights recorded, each ingredient needs 2 signatures (controlled step) • Mixing- methods and tools




Page: 87 of 140

87

• Recording times of holding, mixing, heating, • Recording environmental factors; temp, humidity • Reconciliation of bottles, caps, labels, as well as FG/WIP samples/retains, rejects • In-Process Testing-

o visual uniformity checks; blended powder, dissolved solution o pH, viscosity, o Micro, Chem or other test samples set aside, etc. o QA inspection of capsules/bottles/seals/label placement, o Average weights of capsules/fill volumes, etc. o Packaging instructions, from label to pallet

Note: for each step; decide what the risk to consumer safety or business reputation is for that action not being completed correctly and mandate performer and verifier signatures accordingly. Controlled steps such as exact weights or times or those requiring calculations should always be checked for both signatures to be compliant with FDA regulations. Master Record: MPR Approvals Navigate to: Master Production Record MPR Approvals

MPR Approver names and associated roles with the options to sign for approve or reject are displayed. Note: Error messages specific to steps and or material part #s will appear for authors and approvers to see before attempting to sign. These errors pertaining to inventory use must be resolved before an MPR can be approved. STEP 250. Select the Sign button for approve STEP 251. Sign with credentials and confirm




Page: 88 of 140

88

STEP 252. (log out and log in as another signatory) Sign with the unlock button to unlock the record; write in a reason for unlocking the record in order to proceed.

STEP 253. Make a change to one of the manufacturing instructions or add or delete an instruction. Note: Signature for first approval and first signature for unlock are logged and the Approve and Reject buttons are available to all signatories.

Application Rules for MPR Approvals:

• Users that have been identified as “MPR Approver” via checkbox on the Project Personnel screen will populate the MPR Approval screen. (Note: this defaults to none; all the PMs and QMs in the system for each new project are assigned )

• Once one approval signature is confirmed, the entire MPR record is locked but can be unlocked by a second required signatory and the record can be updated. A reason for unlocking the record is required. Note: if only one signatory is assigned to a project, an MPR for that project will be permanently locked upon first approval.

• Any new updates create a new version which will copy the current version except the for approval actions.

• MPR must be approved before it can be issued/viewed/executed as a BPR. • All information previously entered into the MPR (except Approvers) shall be visible and

locked/un-editable to ensure each time a batch is made it is made using the exact same set of instructions.

Create a BPR directly from the MPR Summary screen. For those roles with access to the MPR screen (PM, PS, QM) a shortcut to creating Batch records is now available. The same rules as outlined in the BPR creation rules apply to the underlying code but there are less steps and less room for operator error.

Note: Only those MPRs in an approved status have the BPR creation icon available.




Page: 89 of 140

89




Page: 90 of 140

90

Batch Production Record

STEP 254. Navigate to Batch Record Batch Production Record

Application Rules for Batch Records: • Through this option a user can add, edit, view, search, issue, perform, approve and print

BPR Records. • Batch records can be printed before, during and/or after completion of the record directly

from the print icon on the summary screen




Page: 91 of 140

91

• A Batch can only be created from an approved MPR (exception: Approval signatures) to ensure that each time a batch is produced it is made using the exact same set of instructions.

• The system will assign a unique batch number to each BPR record. • Users may add in a legacy number for their batch records in the production # field • Cover Page, Materials, Equipment, In Process Testing and Manufacturing Instruction

tabs shall show all the information that was locked down in the corresponding MPR. • Cover Page, Materials, Equipment, In Process Testing tabs shall be read-only • All tabs are locked until the Issuance button is signed by QA • Issuance button prompts the application to check whether the materials in the

BOM/formula/recipe are*: o in an approved state o with signed off specifications o from a qualified vendor (currently assumed by ordering process) o available in sufficient amounts

• Once the Batch has been issued, the Manufacturing Instruction tab allows for the entry of step results in real time during manufacturing by operators

• Once any required data is confirmed the status of the batch goes from issued to in-process • Users that have been identified as “BPR Approver” on the Project Personnel page will

populate the Executed BPR Approvals screen. • The system will allow a user to create multiple Batch Production Record (BPR) copies

from an approved MPR. • The system will automatically assign batch numbers based on the formula: MPR #,

MPR version, sequential batch #. *Exceptions are for those opting to toggle off specifications and/or inventory checks. Batch Production Cover Page STEP 255. Navigate to: Batch Record BPR Cover Page

Show drop downs allow user to see only records of a certain status: Generated: A batch that has been created but not issued Issued: A batch that has been issued but does not have a manufacturing date In-Process: A batch wherein any data has been confirmed on any step Locked: A batch that has one approval signature confirmed. (no subsequent unlocking) Reviewed: A record with all required approval signatures Added to Inv: A batch that has been added to inventory via the BPR cover page.




Page: 92 of 140

92

Users may show Hidden, Visible, or both hidden and visible records (all).

STEP 256. Click




Page: 93 of 140

93

STEP 257. Select “Training-Finished Encapsulated Product” from the Project Title

drop down box STEP 258. Select “Training-Finished Encapsulated Product-FG-14-Primary Container”

from the Product name dropdown box The form is auto-filled with information from the MPR.

STEP 259. Enter “Training Exercise” in the Production # field

STEP 260. Click

STEP 261. Click




Page: 94 of 140

94

STEP 262. Toggle to or sign in with a QA role

STEP 263. Click enter credentials and confirm




Page: 95 of 140

95

STEP 264. Click Note: Production number is now locked down upon Batch Issuance via QM signature. This is to protect traceability.

Certain items of the batch record are now editable using on the BPR Cover page Note: Users may sort batch records by double clicking on the desired column name. STEP 265. Select the Materials tab to view the Bill of Materials (read-only) STEP 266. Select the Equipment tab (read-only) STEP 267. Select the In-Process Tests tab (read-only)

The Cover Page also allows for attaching documentation and printing the Batch Production Record. Note: the cover page attachment approved in the MPR can be overridden at the BPR level.




Page: 96 of 140

96

Batch Record Manufacturing Instructions STEP 268. Navigate to: Batch Production Record Manufacturing Instructions Tab

STEP 269. Log out and log back in as an Operator

STEP 270. Click for Step 10




Page: 97 of 140

97

STEP 271. Enter “Room was cleaned @ 0600 by JDoe with 70% alcohol lot 222” in Result field.

STEP 272. Click STEP 273. Navigate to: Batch Production Record Manufacturing Instructions Tab Application Rules for Batch Production Record Manufacturing Instructions:

• The system will allow the operator to enter data in select fields in the BPR manufacturing steps.

• The operator may enter results, comments and deviations on the manufacturing step as needed and update any attachments as necessary.

• The operator may access the inventory use records for approved material lots and use inventory in real time.

• The material lot numbers, amounts used and signatures for each use within a manufacturing instruction step will be auto-populated in the step.

• Confirming a deviation comment adds a new signature button for a mandatory QA approval of the deviation

• Signature buttons signify that signature is required • Records with missing signatures for performer verifier or QA approval shall not be

Approved nor sent for use in inventory. • For steps with materials and the inventory box checked at the MPR level for those MPRs

with the Auto populate box checked, the automated action step will display. • Error messages will be displayed when the inventory amount used is not within the min

and max parameters set at the MPR level and deviations will be automatically opened. • Material uses for the part number of the selected step will be displayed on the step after

confirmation of uses. Multiple uses will be added to total the amount used for the step and displayed as converted to the unit chosen at the Tmaterial screen.

STEP 274. Click for step 20




Page: 98 of 140

98

STEP 275. Click Application Rules for Inventory Use:

• If the inventory checkbox was checked in the corresponding step in the MPR, then the box will be checked in the BPR, alerting the operator to deplete the specified amount in inventory. An Inventory button appears




Page: 99 of 140

99

• Selecting the Inventory button will bring up the inventory sub-screen with the material that is available for use. The inventory can be depleted at this step in real time. Depleting inventory will require operator signature.

STEP 276. Select the receipt number hyperlink for “Training-Raw Powder”

STEP 277. Click




Page: 100 of 140

100

STEP 278. Select current date from calendar popup STEP 279. Enter 3 in the Qty field




Page: 101 of 140

101

STEP 280. Select Unit “g” from the drop down box STEP 281. Enter “Training” in the Purpose field

STEP 282. Click STEP 283. Enter credentials and confirm

Note: if an amount outside of the min and max defined parameters for the step is confirmed whether in one action or multiple actions, a deviation will be initiated.

STEP 284. Click

STEP 285. Click for “Performer Required”




Page: 102 of 140

102

STEP 286. Enter credentials and confirm STEP 287. Hand control to another user to sign using their credentials, or toggle to

Quality/PM/ role and enter credentials for verifier and confirm STEP 288. Select the appropriate navigation option in the “Action after Confirm”

dropdown

STEP 289. Click STEP 290. Sign for any additional steps entered as an option




Page: 103 of 140

103

Application Rules for Manufacturing Instruction Summary screen

• Yellow checks indicate actions are required • Red checks indicate an error which stops the workflow • Green checks indicate all required actions for that step are completed • No check indicates that the step only requires that a result be entered Note: Make sure to use material first and always confirm your results!

Batch Record Approval STEP 291. Navigate to: Batch Production Record Executed BPR Review STEP 292. Select sign button

STEP 293. Click enter credentials and confirm STEP 294. Repeat for each mandated signature

Note: Signatures for MPR and BPR approvals are UserID-specific, not role specific, so you must be signed in as the user requested.




Page: 104 of 140

104

Application Rules

• The system will lock a BPR including all its data once all assigned BPR approvers have confirmed their approval signatures.

• The first signature confirmation locks a batch • The system will allow a user to create a PDF report of the BPR record.

STEP 295. Navigate to the BPR Cover page tab

STEP 296. Click Application Rules for adding Inventory

• The system will allow a user to add the material from a BPR to the inventory as a WIP or a Finished Goods type material.

• The system will assign a Receipt Number to any WIP or Finished Goods material that is added to inventory. (Requisition numbers for in-house produced goods FG/oWIP will be 0 as they were not requisitioned but manufactured with a batch record.)

STEP 297. Enter 3 into the Qty STEP 298. Verify that “kg” is the unit




Page: 105 of 140

105

STEP 299. Click

STEP 300. Enter credentials and confirm

STEP 301. Click

Sale/Distribution of WIP/FG products STEP 302. Navigate to Inventory Material Use STEP 303. Select the update arrow for “Training - Finished Encapsulated Product” STEP 304. Enter 1000 for the Qty Use STEP 305. Enter “Sent to Distribution center” / “sold to…” STEP 306. Select sign button and enter credentials. STEP 307. Confirm Audit Log STEP 308. Navigate to Audit Audit Log STEP 309. Enter your UserID in the person field STEP 310. Select dates including today or dates of other data entry STEP 311. Select types of access and screens and click search. Data appears




Page: 106 of 140

106

STEP 312. Select Hyperlink for a URL STEP 313. Navigate to Audit Audit Attribute STEP 314. Select attribute from drop down and confirm STEP 315. Select hyperlink for additional information




Page: 107 of 140

107




Page: 108 of 140

108

Reports

Current Inventory, Equipment PM/CAL Dates, Inventory in Quarantine and Inventory Value are direct reports that do not require entry of any additional data for the report to be run.




Page: 109 of 140

109

Low inventory Levels Report requires user to select a below “stock %” on which to report.




Page: 110 of 140

110

Traceability Reports require data to be selected before applicable data can be displayed. Select a lot/production number to see what material lot #s were used to make the batch

Select a raw or WIP material to display all of the batches wherein that vendor lot # was used




Page: 111 of 140

111

Inventory value report assesses value through cost field

Barcode Barcode Scanning Functions: Personnel Badges/ Login and Material Labels. (included in your subscription and must be toggled on by your InstantGMP support specialist) Specs for barcode scanners: You may choose a standard USB or wireless scanner with a 3of9 font, which can be found online and in office stores for as little as $14 USD. The two I tested with most are TaoTronics TT-BS012 and YHD 1100. The YHD is plug and play and very inexpensive. We recommend DYMO Label writer 450 and the “Badge Label” setting, DYMO labels #30857 Barcode scanner – Material Handling




Page: 112 of 140

112

Users can print a label with the status of a material and a barcode for each material receipt – at the Status level. Go to the Inventory->Inventory Status. You can also ask your training specialist to toggle on the feature to automatically print labels upon receipt in order to print all quarantine incoming material labels.

Select for a material receipt to be printed. Ensure that you select the correct printer and size the label to the correct template. (this will vary depending on your version of adobe, printer, browser, OS, etc.) I have chosen badge label.




Page: 113 of 140

113




Page: 114 of 140

114

Select and scan the label. The Inventory Status page for that Receipt/Vendor lot# will appear where the QM can change the status to “Approved.” A new label can be printed with the new status for that Lot/Receipt number.




Page: 115 of 140

115




Page: 116 of 140

116

Using inventory with the scanner

Select on Inventory Management -Inventory Use screen. Or Manufacturing instruction –Inventory Use screen.

Scan the label. You can also type manually into the field and then select Scan button. The Inventory Use screen for scanned receipt/vendor lot # will appear and operators may manually enter how much material they used. Operators may manually sign or sign with their badge. Operators may sign with badge by scanning their badge on any signature screen or popup and confirming. Remember to confirm record on main screen to save the signature to the record.




Page: 117 of 140

117

To set up and print a badge, go to Setup->Personnel and select no earlier than today’s date for a start date and an expiration date for the exp date. Select the “Create Badge” button. Note: the option to create a badge only appears after the first time a personnel record is confirmed. If this is a new record, go back into the record via the update icon and the option will appear.




Page: 118 of 140

118

Click




Page: 119 of 140

119

Navigate back to the Personnel screen; select the print icon in the row for whom you’d like to print a badge.

Return to any screen with a signature prompt and select the button. Scan the badge.

Click Advanced Topics: Hiding Materials Users may Hide materials so that those materials will not show up on specification lists, requisition/P.O. lists, nor BOM selection Lists. Materials with a type of WIP oWIP or FG will not show up on MPR creation selection lists regardless of their previously being included in projects. In order to Hide a material, users must log in with the role of PM, PS, QM, INV or IO. Ensure that the filter for “Visible” is chosen for the filter:




Page: 120 of 140

120

Select the box in the “Hide” column to the left of each record to be hidden.

Select Confirm.

Records disappear from HWW Material screen Select the Filter for “hidden” and select Search. Hidden records are shown.

To Unhide materials, select the check in the boxes for hidden materials

select confirm.

Materials will be shown under “visible” filter.




Page: 121 of 140

121

Additional training videos are available online at http://www.instantgmp.com/support Additional remote training is available via Trainer’s calendar online, http://www.instantgmp.com/support/appointment-request or a quote can be requested via [email protected] Special Functions Integrated Scales: For use with specific scale models that have protocols applied to your instance. Preparation for automated weight recording

Setup

1. Ensure the equipment is in the Equipment list in Setup.

http://www.instantgmp.com/support

http://www.instantgmp.com/support/appointment-request

mailto:[email protected]




Page: 122 of 140

122

2. Ensure InstantGMP has completed the integration of the equipment (indicated by a DBADM electronic signature and date on TEquipment).

3. Navigate to the Equipment list in Setup.

4. Print the Label for the selected equipment.




Page: 123 of 140

123

5. Affix the Label to the equipment.

Serial Interface App

Note: For balances or scales that are not designed to plug and play with Windows 10, a serial interface application must be installed on the computer that is connected to the balance or scale. A program such as Xwedge can perform this function. This program must be running in the background when the scale integration functions are used. If the equipment is unplugged from the computer, the program will end and will have to be restarted when the equipment is plugged in again.

Note: Xwedge works for currently integrated scales and may not be the software needed (if any) for other instruments/equipment.

1. Launch the Xwedge software

2. Select Setups > Setup Devices > Port A > Serial Port




Page: 124 of 140

124

3. Select the Port that has the connection to your equipment




Page: 125 of 140

125

(go to configuration>hardware OR Control panel>hardware and sound>Devices and Printers to see the “COM” port)

and select “Save”

4. Select “Generic Scale or bi-directional Device” from first drop down, make sure that fields match image below and Click SAVE in upper left corner, then close the next popup




Page: 126 of 140

126

5. Click Start

6. Ensure equipment is connected to computer through the selected COM port. Press “Print” on the equipment. If the connection is working, the “CAPTURED SERIAL DATA” field should contain data sent by the equipment. (notice “0.0g” in field)




Page: 127 of 140

127

Scan and Get Weight during batch manufacturing

1. Navigate to the manufacturing instruction of a batch production record where a material needs to be weighed.

2. Tare equipment, then measure out the required amount of material.

3. Allow equipment to stabilize.

4. Click the “Scan and Get Weight" button on the manufacturing instruction screen.




Page: 128 of 140

128

5. A popup will appear for the material scan.

6. Scan the bar code on the label – a popup will update for the equipment scan.




Page: 129 of 140

129

7. Scan the bar code on the equipment – a popup will update with the instruction “Press PRINT on equipment”.

8. Press the Print button on the equipment.

9. The popup updates the digital signature.




Page: 130 of 140

130

10. Scan your personnel badge or enter your Username and Password.

Note: make sure your browser does not autofill in your name and password.

11. The Inventory Use screen will appear with the current date, the quantity of material measured, the unit from the equipment and the digital signature filled in.




Page: 131 of 140

131

12. Click “Confirm” to return to the manufacturing instruction screen – the Receipt #, Vendor Lot #, Quantity and Unit, digital signature, Equipment # and Equipment Name will automatically be displayed.

13. The Weighing activity will automatically be entered into the Equipment Log with the corresponding Start and End Dates, Product Name, Batch # and digital signature of the signer showing up as the Operator’s signature.




Page: 132 of 140

132

Approvals System Owner: Richard Soltero

President InstantGMP

9/8/16

Software QA: Gretchen Rizor

QA InstantGMP

9/8/2016

InstantGMP Release Notes for Version 3.000.001 5/9/2016 New User Interface Features in v3.000 • Personalized view on each screen • Move, resize or hide columns in grids • Clear Control Preferences Icon clears all view settings on a screen and restores default view on that screen • Sort grid data by any column heading • Collapse and restore menu and search panels • Set quantity of rows to display for each grid • Set favorite menu items • Icons only inside lists; buttons with text everywhere else • The search and filter functions in a collapsible panel to the right • Search starts as soon as characters are entered (some delays may be experienced if there are a lot of records in a grid) • Page control, "Confirm", "Cancel", "Close" in the bottom panel • Insert icon replaced by "Add New Record“ button in bottom panel • Menu in a collapsible panel on the left • Open folder icon will indicate that the submenus are displayed and a closed folder icon

will indicate that the submenus are hidden. • Redundant check boxes eliminated Error messages • Appear at the top right of the page • Disappear after a few seconds, but can be recalled by clicking its tab Favorites • Right click on menu item adds title to favorites • Star icon appears in main header when a favorite is selected • Clicking star icon shows that specific users' favorites only • Clicking on “Home" icon at the left side of “Favorites“ shows all menu items




Page: 133 of 140

133

Check mark colors have meanings • Grey check mark means True (selected), transparent means false • Yellow check mark means an action is expected • Green check mark means action is completed • Red check mark means a problem that stops the workflow Bin Location Features • Facility and room specific Storage at each facility identified by Bin location • Materials in each facility are tracked and managed separately from the inventory at the other facilities • Bin Location shown on Inventory summary screens • History of changes in Bin Location maintained in system • Bin Location report shows the current inventory in a specified Bin • Inventory Location is accessed from Inventory Management screen • To assign/change a material’s location

• Select Facility • Select Room • Select Bin where material will be stored • Sign and Confirm

Current Inventory Report • Now shows bin location of each item in inventory • Filters show what is in a specific bin location Other New Features in v3.000 Digits and decimals

• All numeric fields now show 6 digits to the right of the decimal • When there are more than 3 digits to the left, commas appear • A single click on the number highlights the entire number and allows it to be replaced

Specifications • When a new version after version 1 is initiated a “Reason for Change” field appears.

New BRP Features • BPR Manufacturing Instructions Summary now in grid format • Status column shows colored icon indicating status of manufacturing step • Yellow check mark means an action is expected • Green check mark means all actions on that step are completed • Red check mark means a deviation occurred and requires a QA signature




Page: 134 of 140

134

InstantGMP Release notes for version 2.054.001 03/01/16 Improvements

• Automatic conversion of Unit on BPR Instructions to Material Unit. • Automatic conversion of Unit on BPR Instructions Usage (on multiple lines) to Material

Unit.

Fixes

• On some instances when Inventory levels were above 100% the application experience a printout error.

• When a material was added to inventory, the default option was REJECTED instead of QUARANTINE.

• Application was not considering the scenario of using different types of Units in the BPR Instruction material usage and Target Unit.

• Access to Client Option on Administrator menu was not visible for Administrators. • In some instances, when the Production Id was bigger than 40 characters the Inventory

usage on that Batch was not properly shown. InstantGMP Release Notes for Version 2.053.002 1/6/2015 This version is a patch fix needed for allowing distributors not using units to be able to create new BPRs from existing approved MPRs. InstantGMP Release notes for version 2.053.001 12/11/15 New Functionalities

• New MPR and BPR workflow allows users to navigate between manufacturing instruction steps without scrolling on summary page.

• New BPR functionality automatically checks for quantity used of material on each step for defined range.




Page: 135 of 140

135

• Added option to Unlock “Locked” MPRs and make edits. Signature and comment log retained for that version.

• Introduced Medical Device Manufacturing Industry nomenclature. • New Min and Max fields to set at the MPR manufacturing instruction steps calling for

use of material part #s. • Smart fields for Min and Max on the BPR alert user to OOS addition of material. • New smart messages alert user to inconsistencies in the BOM and the manufacturing

instruction steps with material part # use.

Improvements

• Signature for material use now included on the inventory traceability table in the BPR. • Inventory Value report now expresses conversion of values based on Cost entered at the

material requisition screen.

Fixes

• Some minor spelling errors within error messages. • Filter options on Material Types were not properly displaying results. • Under certain conditions BPR printout showed twice when printing BPRs • Unit for approved inventory shown on Batch issuance error message updated.

InstantGMP Release 2.052.001 12/6/15 New Functionalities

• Expanded badge signature capabilities to system-wide usage. • Added new workflows focused on Project Management functionalities allowing for

projects to include multiple products for multiple clients with multiple user access control under multiple roles.

• Added new Material Classifications to help employ naming conventions for incoming materials versus outgoing manufactured, packaged or labelled WIPs or finished goods.

• Updated the definition of the Product Name which now includes a Material Name, Strength, Batch Unit and Primary Container and will be displayed as such.

• Added option to “Reject” MPRs. • Added MPR status definitions for a clearer status control

• In-Process • Locked • Rejected • Approved

• Added new functionality and Rules for creating MPRs:




Page: 136 of 140

136

• More rules for better Version control and traceability • More rules and more copy options for better control and traceability • Option for Automatic Scale up/down of recipe

• Added ability to hide unused or superseded MPRs • Added sorting for hidden, visible, or all MPRs • Added new BPR status definitions for clearer processing control

• Generated • Issued • In-Process • Locked • Reviewed • Added to Inventory

• Added automated population of Bill of Materials Quantities to be used in BPR manufacturing instructions.

• Automated population of material use data from the inventory screens to the BPR instructions with a list of vendor lots and total quantity of material used.

• Added new Inventory Value Report. Improvements

• Simplified Menu Navigation based on new workflows. • Improved MPR and BPR printouts. • Pared down auto filter drop down for authors to only include roles that can write MPR. • Increased level of detail on Vendor and Material traceability reports. • Changed Manufacturing date to transition from BPR’s “Issued” to “In-Process” when a

Manufacturing Instruction is open for the first time. • Simplified change of roles for user with multiple roles. • Auto-assignment of PM and QM personnel to projects for better visibility and ease of

use.

Fixes

• Access to attachments on Approved MPR’s Manufacturing Instructions • Some “Sort” and “Search” functions on main screens not working as expected. • Under certain conditions, if you changed your password and immediately logged out, you

couldn’t login again unless reopening the browser.




Page: 137 of 140

137

InstantGMP MES Release notes version 2.051.002 6/25/15 New Functionalities

• New barcode scanning solution that enhances material handling. • Ability to permanently “hide” and filter Master Records. • New system-wide digital signature scheme implementation through barcode scanning of

validated user badges. • Implementation of Company Logo on login screen along with Company name on

application header for more clarity on customers with multiple instances. Improvements

• Extended Specification Acceptance Limit field to 120 characters long on PDF print out under Material Specifications

• New mechanisms for attachment handling, making them more efficient and user friendly. • Improved company boarding and Material import mechanism. • Lock down of Production # upon QM approval for easier GMP compliance. • New redesign and export functionalities for Quarantine Reports • Improved usability decreasing visibility on non-essential actions.

Fixes

• Under certain conditions after session timeout, an immediate login would render the main menu invisible.

• Minor cosmetic fixes on MPR PDF printout.

New Functionalities

• New barcode scanning solution that enhances material handling. • Ability to permanently “hide” and filter Master Records. • New system-wide digital signature scheme implementation through barcode scanning of

validated user badges. • Implementation of Company Logo on login screen along with Company name on

application header for more clarity on customers with multiple instances.




Page: 138 of 140

138

Improvements

• Extended Specification Acceptance Limit field to 120 characters long on PDF print out under Material Specifications

• New mechanisms for attachment handling, making them more efficient and user friendly. • Improved company boarding and Material import mechanism. • Lock down of Production # upon QM approval for easier GMP compliance. • New redesign and export functionalities for Quarantine Reports • Improved usability decreasing visibility on non-essential actions.

Fixes

• Under certain conditions after session timeout, an immediate login would render the main menu invisible.

• Minor cosmetic fixes on MPR PDF printout.

InstantGMP MES Release notes version 2.050.001 5/26/15 New Functionality:

• New streamlined workflow for Material Specifications with less screens and the ability to filter by “Approved” “Pending Approval” and “All.” *

• Option to allow or disallow Finished Goods and WIPs on MPR Bill of Materials. • Ability to assign personnel a default role on the TPersonnel screen. • Ability to sort BPRs by (descending) issuance time date stamp.

Improvements:

• Reports are now integrated into IGMP with better functionality and minimal lag time. • QuickBooks Data Transfer Tool official release and improved P.O. report.

Fixes:

• Product and Material traceability reports now pull all relevant data. • Sorting on Material Name on Material screen now works properly • Sorting on Clients on Project screen now works properly. • Attachment names now always present.




Page: 139 of 140

139

InstantGMP MES Release Notes 2.046.002 Additional Functionality:

Data transfer to QuickBooks: Requisitions and Current Inventory

Added Avg Cost/Unit field and Account for Materials – QuickBooks

Report for Cost of Batch ingredients and manufacturing overhead

Added Costing functionality to BOM calculator

Material Types are pre-populated and chosen from a drop down box

Improvements:

Vendor name included on additional screens for easier traceability

Prevents inclusion of part # of FG/WIP in an MPR recipe for said FG/WIP

Requisition screen streamlined

Changes:

Vendors are now Qualified on the Vendor page and there is no need to create vendor groups.

Vendors are now tied to materials at the receipt level

Note: please change any personnel with ADM role meant to sign for PM or QM signatures to reflect those roles, as the ADM and Site admin roles have recently changed and the ADM has no signature rights and can only create new personnel. Contact your InstantGMP Support Associate for screenshots or an Adobe Connect session if you are having difficulty doing so. END




Page: 140 of 140

140

instantgmp, inc. - title: document no: csvp-um-igmp- 3.001.101 … · 2020-06-04 · instantgmp...

Documents