c2: sdms/vp - managing gxp workflows · need for standard interface to external systems (lims, sap)...

C2: SDMS/VP - Managing GxP Workflows(Future Directions for SDMS Vision Publisher(Future Directions for SDMS Vision Publisher,

the ELN for Analytical Laboratories)

Ralf Ralf SchröderSchröder

Informatics Solution ConsultantInformatics Solution Consultant

©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation

What is Possible Today?What is Possible Today?

Procedure ExampleProcedure Example

©2011 Waters Corporation 2

ExampleDissolution Testingg

LIMS

Supervisor Assigns TestSupervisor

Assigns TestSupervisor Performs Sample DispositionSupervisor Performs Sample Disposition

SDMS Vision Publisher

Analyst Gets Specs and Method


Analyst Checks InstrumentationAnalyst Checks Instrumentation

Analyst Prepares Sample


Analyst Sets up Tests


Analyst Performs Calculations


Analyst Compares Result against SpecsAnalyst Compares

Result against SpecsPeer Analyst

Performs Test ReviewPeer Analyst

Performs Test Review

CDS

Analyst Runs TestAnalyst

Runs TestAnalyst

Records ResultsAnalyst

Records Results


Runs TestRuns Test Records ResultsRecords Results

Load Dissolution Templatep


Step 0Step 0 Step 1Step 1 Step 2Step 2 Step 3Step 3 Step 4Step 4 Step 5Step 5 Step 6Step 6 TransferTransfer

Verify Training Statusy g



Get Sample Information from LIMSp



Interface Chemical Inventory Databasey



Weighing Tabletsg g



Loading Sample Set Methodg p



Update Batch Informationp



Updated Form with Empower Resultsp p



Transfer Information to LIMS



ExampleDissolution Testingg

LIMS

Supervisor Assigns TestSupervisor

Assigns TestSupervisor Performs Sample DispositionSupervisor Performs Sample Disposition

SDMS Vision Publisher



Analyst Checks InstrumentationAnalyst Checks Instrumentation







Analyst Compares Result against SpecsAnalyst Compares

Result against SpecsPeer Analyst

Performs Test ReviewPeer Analyst

Performs Test Review

CDS

Analyst Runs TestAnalyst

Runs TestAnalyst

Records ResultsAnalyst

Records Results


Runs TestRuns Test Records ResultsRecords Results

Future Directions forFuture Directions forSDMS Vision Publisher

©2009 Waters Corporation | COMPANY CONFIDENTIAL©2011 Waters Corporation

Topicsp

Sample Management and Sample TrackingSample Management and Sample Tracking

Specification Management

Archival


Why Sample Management?y p g

Currently all information living in SDMS Vision Publisher as Currently all information living in SDMS Vision Publisher as metadata or section „results“

Need structured information about samples and test results I t t f t di d l b t ti ti— Important for trending and lab statistics

Ability needed to organize the day-to-day work

Need for standard interface to external systems (LIMS, SAP)

Gives SDMS Vision Publisher ability to serve as LIMS-like tool in smaller labs

SAP/QM (or even some LIMS) often not desired as bench-tool SAP/QM (or even some LIMS) often not desired as bench-tool in the lab


Sample Managementp g

HierarchyHierarchy— Test Request -> Samples -> Tests -> Results

Views of each level must be possible

l kSample Tracking— Status management on request and test level

Possibility to update missing information (with Audit Trail)y p g ( )

Configurable information to be displayed



Manager Use CaseManager Use Case— Needs overview about all requests

— Must be able to assign tests to analysts

Must be able to get overview about entire test request — Must be able to get overview about entire test request (see request dashboard)

— Must be able to create test requests manually, including

S lo Samples

o Tests with limits

• Based on specification -> Specification handling in VP

— Must be able to trigger approval process

o Create and sign report

— Approves single test documents


pp g


Analyst Use CasesAnalyst Use Cases— Analyst must be able to find all pending tests for certain test type

— Analyst must be able to find all tests assigned to him

Must be able to create worksheet(s)/document(s) for selected — Must be able to create worksheet(s)/document(s) for selected tests

o One worksheet where multiple samples are processed

O k h t lo One worksheet per sample

o Test -> template mapping needed

— Analyst must be able to check in/check out samples

— Must be able to print sample labels



Easy navigation necessaryEasy navigation necessary— Fast access to data without need to enter several search criteria

o -> ‚My work‘ approach

Wi d t t t t tWizard to create new test requests— Assign samples

— Assign sests

o Based on specification

— Ability to copy existing requests



Sample OverviewSample Overview— Check in/check out samples

— Ability to create new samples (also sub-samples) for existing test requeststest requests

— Show samples for selected order(s)/request(s) or show all samples for entered search criteria

Ability to print sample labels with barcode— Ability to print sample labels with barcode



Request dashbord (Review-By-Exception)Actually a result overview— Actually a result overview

— Shows all tests (pending and processed) and their results for the selected order, indicating:

A t l lto Actual result

o Specification limits

o Sample name

o Creator of the result

o Link to the SDMS Vision Publisher document

o Result changed with a reason for change? g g

o Out of the specification events?

o Result approved?

o Used instruments fit-for-use?


o Used instruments fit-for-use?

o Used reagents fit-for-use?

o …


ApprovalApproval— Request dashboard is starting point

— Possibility to approve entire test request

Approval mechanism independent of document approval— Approval mechanism independent of document approval

o Signature cycle must be linked to test request

— User actually signs report

o Signatures need to be embedded in PDF report (c.f. SAFE signature)


Specification Managementp g

Important for standalone SDMS Vision Publisher scenariosImportant for standalone SDMS Vision Publisher scenarios

Specification is a set of tests and their requirements— Test limits

R lt t— Result type

— Supports quantitatative and qualitative results

Definition of — Methods

— Tests

— Mapping between method and templateMapping between method and template

— Effort

Specifications are versionized

U i ifi i


User can assign specification to test request

Archival Capabilitiesp

Currently no means to remove data from SDMS Vision Currently no means to remove data from SDMS Vision Publisher database

Remove binary data from online databaseC fi bl hi i h d l— Configurable archiving schedule

Metadata and PDF reports remain in database

Restoring data on demand


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c2: sdms/vp - managing gxp workflows · need for standard interface to external systems (lims, sap)...

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