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Copyright Yokogawa Electric Corporation February 7 th, 2006 Saturday, November 28, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02 Slide 2 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch PIMS Requirements Operators Process Technologists Managers Quality Assurance Scheduling & Planning Production Integrated verified timely information Company Objectives Increase productivity Raise performance Reduce costs Regulatory compliance Improve quality Reduce decision time Meet standards Improve efficiency Reduce downtime Shared perspective & common goal More awareness & reduced confusion Easy data access & management Increase profits Process Information Data Control Plant Information Slide 3 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 3 Yokogawas Exa Product Line IT products for process plants Advanced operation Scheduling Optimization Plant Information Management Systems (PIMS) Exaquantum Field proven PIMS First released in 2000 Exaquantum/SER (Sequence of Events Recorder) in 2003 Batch extensions in 2003 Slide 4 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 4 Yokogawa PIMS Solution Exaquantum/PIMS Plant Information Management System Slide 5 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 5 Exaquantum/PIMS Server Exaquantum Architecture Exaquantum/Explorer ClientsExaquantum/Web Clients IntranetLocal Area Network Web Server Administration Tool Role Based View PCS Interface Exaquantum/PIMS Server Long-term Archive Historian Real Time Database External data: ERP, LIMS, CMMS, etc. OPC Servers, DCSs, PLCs, etc. Plant Slide 6 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 6 Typical Exaquantum System CS 3000FCS Exaquantum ServerExaquantum Clients Exaopc Station/HISHIS Other OPC DA servers are available for: ABB Allen-Bradley AspenTech Bailey Eurotherm Fisher-Rosemount Intellution Moore plus others Exaquantum/PIMS R2.02.50 supports: Yokogawa Exaopc for XL, XL, CENTUM CS, CS 1000 and CS 3000 Yokogawa HISopc for CS 1000 and CS 3000 Matrikon OPC server for Honeywell TDC 3000, Foxboro I/A series and Modbus Slide 7 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 7 Exaquantum Licenses Worldwide Over 575 Exaquantum systems as of January 2006 Slide 8 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 8 Equalisation with Yokogawa DCS Data Quality retained throughout the system Aggregations form part of the Tag Data structure Tags can be organised in User Defined Function Blocks Database organised in Plant Hierarchy Format Access control configurable by plant area or tag level Production Calendar based aggregations and reports User Role Based View of Plant Hierarchy Exaquantum: Unique Features Slide 9 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 9 Sophisticated OPC Client Capability Yokogawa DCS support includes: CENTUM CS 1000/CS 3000 CENTUM CS CENTUM-XL CENTUM XL Yokogawa OPC enabled devices DAQ stations, Stardom, ProSafe MULCOM, etc. Third Party OPC support Matrikon OPC Servers for Honeywell, Foxboro and Modbus Supports other DA2.05a compliant OPC Servers Control System connectivity Slide 10 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 10 Yokogawa PIMS Solution Exaquantum/Batch Batch Plant Information Management System Slide 11 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 11 Exaquantum/Batch Extensions to Exaquantum to serve batch process industry Designed for Low Total Cost of Ownership Based upon S88 models & terminology Tightly coupled with CS Batch 1000 & CS Batch 3000 Web based user interface Standard displays Built in analysis functions Powerful reporting package included Designed for regulated environments Slide 12 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 12 Why Batch PIMS? Batch processing industries have additional requirements compared to continuous industries Batch orientation more important than time/tag orientation Recipe driven S88 Traditional PIMS are lacking when used in batch applications Require considerable engineering No inherent batch intelligence Recipe & batch data usually coerced into continuous trend of tag values Difficult to use stored data Easier regulatory compliance Slide 13 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 13 Exaquantum/PIMS Server Exaquantum + Batch = Exaquantum/Batch Batch Web Clients IntranetLocal Area Network Web Server Administration Tool Role Based View PCS Interface Exaquantum/PIMS Server Long-term Archive Historian Real Time Database External data: ERP, LIMS, CMMS, etc. OPC Servers, DCSs, PLCs, etc. Plant Batch Database Slide 14 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 14 V net Ethernet FCS Unit Supervision Master Recipe Storage Collecting: Master Recipes Batch/Control Recipe Data Equipment Configuration Alarm & Events Trend Data CS Batch 1000 CS Batch 3000 Exaquantum/Batch Dual Exaopc Servers Yokogawa Batch Solutions Users Providing users with reports and analysis capabilities Control Recipe Data Master Recipe Data ENG HIS Batch Servers Slide 15 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 15 S88 Production Information Management Outside the scope of SP88 standard Recipe Management Production Planning & Scheduling Production Information Management Process Management Personnel & Environmental Protection Process Control Unit Supervision ProSafe Slide 16 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 16 When did we make batch B-4290 & what equipment did it use? What products were in production at 14:00, 2 June 2000? What was unit RXR1 doing at 14:00, 2 June 2000? How did we make the product made in 2000? Questions, Questions, Questions Slide 17 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 17 How long does it usually take to make this product? Which Reactor typically makes this product quickest? What percent of the time are the reactors in use? What other batches were in progress when B- 4290 was running? What products have the greatest variability in their production? Questions, Questions, Questions Slide 18 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 18 Key Features Standard Analysis Data Batch/Control Recipe Data Cycle time & Unit utilization automatically calculated Automatically generated charts Immediate Return on Investment (ROI) potential Use to improve production throughput and asset utilization Supports customer s Six Sigma programs Out of Box with CS Batch 1000/3000 OPC Batch used to provide immediate usability & benefit without cumbersome configuration Automatically adapts to application configuration changes Low life-cycle costs Web Browsing Batch, master recipe & equipment data organized into one web BatchWeb Ad hoc web access to data without custom display generation Secure data storage, minimal client administration Reporting Secure report package for regulatory reports Reports can contain thousands of data items Batch End Reports, Batch Comparison, Product Roll-up Reports Powerful tool for managing batch history and master recipe data Slide 19 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 19 Features Automatic Batch Data & Master Recipe collection Minimizes setup time and engineering For CS Batch 1000/3000 R3.03+ with Exaopc Custom Batch Data collection For any control/MES system with an OPC Data Access 2.05a server Primary data source or may augment automatic batch data collection Web based user interface Standard display structure based upon S88 Batch trends, Gantt charts, Data filtering, Standard cycle time analysis displays Secure access to data Access data from any intranet capable PC Slide 20 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 20 Features Strong batch reporting platform Batch, master recipe & equipment data available for any report Custom reports can contain thousands of data items and perform processing Standard analysis calculations & charts Cycle time & batch performance metrics automatically maintained Pharmaceutical industry support U.S. FDA 21 CFR Part 11 Slide 21 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 21 Features High level batch solutions coupled with batch control system Traditional Time & Tag based PIMS no longer sufficient for batch solutions High performance & great value Powerful Exaquantum/Batch Excel add-in Slide 22 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 22 Standards Based OPC Data Access (DA 2.05a) Alarm & Events (A&E 1.02) Historical Data Access (HDA 1.1) Batch v1.0 S88 Part 1 Models & Terminology Part 2 Data Model SQL ANSI standard supported by Microsoft SQL Server 2000 World Wide Web Consortium HTTP XML Slide 23 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 23 Windows 2000 or 2003 Server Security uses domain accounts and user groups Microsoft SQL Server 2000 relational database Microsoft Office 2000, XP or 2003 (for reporting) Microsoft.Net architecture Clients use Microsoft Internet Explorer 6 Web server uses Microsoft IIS Commercial Off The Shelf Technology Slide 24 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 24 Batch Database Microsoft SQL Server Batch Server Exaopc Batch DA & AE Server Exaopc Master Recipe Data Collection Batch Metrics Calculations Automatic Batch Data Collection Report Distribution - Hardcopy - e-mail - Print - Acrobat - Report Archive Custom Batch Data Collection Exaquantum Historian (Trend & Event Data) CS Batch 1000/3000 On-line Configuration Utilities Report Configuration Report Runtime Functional Configuration BatchWeb Client (IE6) Exaquantum/Batch OPC DA Server Exaopc Others Other PAS/MES BatchWeb Server Reporting Batch Data Browsing Basic Analysis Charts Clients Slide 25 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 25 Control Recipe Data Automatically collected No Engineering, reduced Maintenance Via Exaopc Batch Server Equipment Plant hierarchy automatically collected Via Exaopc Batch Server Master Recipes Each master recipe loaded to HIS is collected Automatic - No Engineering, reduced Maintenance Trend Data Configure Exaquantum to collect from CS Batch 1000/3000 Via Exaopc Data Access Server Events Automatically collected - No Engineering, reduced Maintenance Via Exaopc Alarm & Event Server Data Collection Slide 26 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 26 Control Recipe Data Dual Exaopc Batch Server CS Batch 1000/3000 buffers data Equipment Plant hierarchy should not be changed until after switch over Master Recipes Recipes collected when communications re-established Trend Data Redundant Exaopc Data Access Server Events Redundant Exaopc Alarm & Event Server High Data Availability Slide 27 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 27 Exaopc Yokogawas OPC product line Supports OPC Foundation Specifications Data Access 2.05a (DA) Alarm & Events 1.02 (A&E) HDA 1.1 (includes Alarms & Events) Batch 1.0 Security DA and A&E data buffering Exaopc Server DAA&E HDABatch Slide 28 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 28 V-net Ethernet FCS Unit Supervision HIS & Batch Servers Exaquantum/Batch Exaopc Servers AB Exaquantum/Batch Exaopc Server A Exaopc Client Exaquantum/Batch OPC Client Exaopc Server Data Access Alarm & Event Redundant OPC DA and A&E Servers Exaopc Server B CS Batch 1000/3000 Slide 29 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 29 V net Ethernet FCS Unit Supervision His & Batch Servers Exaquantum/Batch Exaopc Servers AB Exaquantum/Batch Exaopc Server A Exaquantum/Batch OPC Client Batch Dual OPC Batch Servers Exaopc Server B CS Batch 1000/3000 Slide 30 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 30 Collects data via Exaopc Batch Server Batch and equipment data uses S88 models & terminology No engineering needed to set up, just minor configuration (enter server locations, ) Automatic Batch Data Collection Slide 31 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 31 Exaquantum/Batch collects data throughout a batch: Batch is reserved/first created Batch starts Unit recipes start/end Batch end When plant hierarchy is modified As data is collected, it can be viewed on BatchWeb and included in reports Automatic Batch Data Collection Slide 32 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 32 Automatic Batch Data Collection Data Collected: Batch header data Batch IDMaster Recipe IDMaster Recipe Revision Start TimeEnd TimeTrain/Path Unit Recipe data UnitStart time OperationsEnd Time Formula data All formula items are collected Formula IDValueEngineering Units Slide 33 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 33 Master Recipe Collection CS Batch 1000/3000 master recipes automatically collected Recipes collected after loaded into the HIS No user involvement required Exaquantum/Batch assigned revision time stamps Identifies exact copy of a master recipe used for a batch Entire master recipe is saved in the Exaquantum/Batch database Available for reporting Batch metrics rolled-up to master recipe level Determines batch cycle time trends as recipes are modified Slide 34 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 34 Automatic BDC Catch-up Batch Data Catch-up available as long as batch is not deleted from CS Batch 1000/3000 when Exaquantum/Batch - OPC connection is down Batch/Control Recipe data is stored in CS Batch 1000/3000 When connection is re-established Exaquantum/Batch restarts data collection Alarm & Event Data Standard Exaquantum functionality provides: Exaopc A&E server buffering Catch-up uses buffering feature for controlled shutdowns Slide 35 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 35 Automatic BDC Catch-up Trend Data Standard Exaquantum functionality provides: Exaopc Data Access server provides buffering of data for controlled shutdowns Catch-up occurs when connection re-established Standard Exaquantum functionality Slide 36 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 36 Enables data collection from any OPC Data Access enabled control or information system, such as: Laboratory system integration with CS Batch 1000/3000 CS 1000/3000 without a batch package Centum CS or Centum CS Batch Custom engineering required to map data into Exaquantum/Batch S88 data structures May be used with or without automatic data collection Custom Batch Data Collection Slide 37 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 37 All data stored in relational database in same format and capabilities as with automatic data collection Amount of data collected is variable Minimum = batch ID, start/end time, product, formula item values, Maximum = complete control recipe data (same as with automatic batch data collection) Custom Batch Data Collection Slide 38 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 38 Custom Batch Data Collection OPC DA Server Tag TTT Trend Database Batch Database PAS / Lab System Tag XXX Tag YYY Tag ZZZ Exaquantu m Graphics Manually Entered Data Equipment Hierarchy Data Batch Properties Formula Properties Unit Recipe Properties Formula Properties Operation Properties Formula Properties Batch Data Trigger: TTT Item 1: XXX Item 2: YYY Item 3: ZZZ Manual Entry Dialog Slide 39 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 39 Yokogawa PIMS Solution Exaquantum/Batch BatchWeb Slide 40 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 40 Web based user interface BatchWeb Intranet access Remote access within intranet capabilities Low cost of ownership Windows 2000 domain security so users not tied to one PC BatchWeb Features Slide 41 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 41 Standard, preformatted displays for browsing of batch, equipment & master recipe data without configuration of displays Automatically generated charts Cycle time Performance Ratings Gantt Charts BatchWeb Features Slide 42 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 42 Dynamically Built Web Pages Batch Database Exaquantum Trend Database Exaquantum Event Database Web Server (IIS) BatchWeb Applications Yokogawa Framework Web Browser (Internet Explorer 6) Data Driven Page layouts are called up to display selected data set Web Portal Individual pages are organized as a web site called BatchWeb BatchWeb is built upon the common web framework called Tropicana Web Page Layouts Slide 43 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 43 Basic Display Layout Standard Functions Application View Area Slide 44 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 44 BatchWeb Layout Related Views Select application view MyList Select item for personalized view Batch List Select particular batches to call up detail views Filter Set conditions to adjust view data scope Main Menu Select data catagory Slide 45 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 45 BatchWeb Data Scope Data Scope filters data by time and content By Time Time1 Time2 Time1 +/- Time Period (days, hours, minutes) Last n weeks/months/years Since start of week/month/year By Content BatchMaster RecipeUnit Performance RatingCampaign Slide 46 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 46 Formula Items Slide 47 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 47 Batch Summary Each view displays data for 1 batch Drop down list automatically populated from selected batches Slide 48 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 48 Batch Trend Views Compare trends Batch/unit recipe to batch/unit recipe Unit to unit Include common equipment Batch trend templates Pre-configured groups of tags & tag aliases BatchWeb context (time & batch list) applied Trend graphs 6 pens Batch relative time Batch start time = 0 Batch & unit recipe start/end times indicated on trend Slide 49 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 49 Batch Trend Chart Selection Slide 50 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 50 Batch Trend Slide 51 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 51 Batch Trend View Design Chart: 6 Pens Individual Y Axis X Axis Controls: Zoom in/out Batch relative or absolute time Page forward/backward Legend: Tag / Tag Alias Batch ID Cursor Time Value at cursor Engineering Units Automatic Look up: Template configuration maps Tag Aliases to Exaquantum Tags BatchWeb user selects Batch(es) and Template BatchWeb automatically makes Tag Alias, Tag, Unit Recipe, Unit associations and builds trend Batch & Unit Recipe Flags: Indicate start/end of unit recipes using tags Slide 52 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 52 Batch Trend Template Slide 53 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 53 Analysis Views Automatically generated Cycle time Batch & unit recipe cycle times Batch & unit recipe cycle timer frequency Performance ratings Batch & unit recipe performance ratings Batch & unit recipe performance rating frequency Filter by unit, batch ID, master recipe, performance rating Slide 54 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 54 Cycle Time per Batch 0 10 20 30 40 50 60 B-1B-2 B-3B-4B-5B-6B-7B-8B-9 B-10 Batch IDs Hours Refine data sets Find individual batch IDs Starting point to drill down Narrow distribution of batches within standard deviation Overview of performance Visualizes variability around mean Compare before & after counter- measures to find improvements Narrower set of peaks is best Cycle Time Chart Example Cycle Time Frequency Distribution 0 5 10 15 20 25 30 35 40 45 50 272829303132333435363738394041 Cycle Time in Hours Number of Batches Eliminate outlaying performance Slide 55 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 55 Cycle Time Chart Slide 56 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 56 Performance Rating Chart Red Bars indicate automatic performance values manually overridden Each Bar = 1 Batch Y Axis = Performance Rating Slide 57 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 57 Batch Gantt Chart Gantt Chart showing absolute time Time based view of batch & unit recipe execution Shows batches by default Unit recipes in each batch may be shown also Uses BatchWeb context (time & data filter) Absolute or batch relative time basis Gantt Chart showing relative time Relative time display All batches start at Time = 0 Quick comparison between batches from different time periods Slide 58 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 58 Batch Gantt Chart showing absolute time Slide 59 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 59 Batch Gantt Chart showing relative time Slide 60 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 60 Batch Event View Table of events Filter by event type Common, non-batch specific events may be included Absolute or batch relative timestamps Slide 61 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 61 Unit Utilization Chart Gantt chart showing when each unit was used by a batch/unit recipe Unit recipes in same batch are in the same color Graphically conveys unit utilization Corresponding table view Slide 62 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 62 Yokogawa PIMS Solution Exaquantum/Batch Reporting Slide 63 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 63 Secure Reporting Package Access control Restricted access to design & generation functions Data integrity Reports stored in database in Excel (XLS) Adobe Acrobat format (PDF) Access to reports only possible using Exaquantum/Batch programs Version control of report templates Report Archive maintains copy of all reports Slide 64 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 64 Batch Reporting Excel based reporting package Excel is wrapped with an Exaquantum/Batch reporting application Virtually unlimited amount of data items per report Slide 65 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 65 Batch Reporting All data in relational database available for custom reports All Batch, Master Recipe & Equipment data available Exaquantum Historian (trend) data available Alarm & Event data available Reports scheduled on batch/unit recipe end or by time Distribution options Slide 66 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 66 Batch Report Process Flow XLS Batch Data Collection BatchWe b Run report at Batch/Unit Recipe End Run reports daily, weekly or monthly Create/modify template Approve template Set report options Excel View reports Run reports Approve reports Check in/out Excel file Exaquantum Email distribution of reports Templates stored in database, not directly accessible to Excel users Report Template Management Report Templates Batch Database Report Runtime Excel PDF XLS Report Archive Slide 67 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 67 Report Template Management User defined report template groups and reports All versions of report templates preserved Report template options Slide 68 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 68 Microsoft Query Standard tools for building reports MS Query instruction can be found in local languages & classes Build custom queries to suit business needs IT trained personnel able to build reports Slide 69 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 69 Microsoft Query Icecap Database contains special View tables for simpler access to data Use common Microsoft tools for building queries Slide 70 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 70 Running Reports Scheduled Reports Parameters automatically obtained from database Event based Batch and/or unit recipe end Conditional based upon master recipe Time based Manually Use BatchWeb Enter parameter values Slide 71 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 71 Report Archive Report Archive is a repository containing Excel and/or Acrobat files Every report is saved to the archive Archive contents available via the BatchWeb View Approve Check-Out/In Slide 72 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 72 Report Viewer Adobe Acrobat files Options to Restrict changes Require approval Report stored in archive Report Approval Report output may be Viewed on web Printed E-mailed to distribution list Stored for future use Slide 73 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 73 Yokogawa PIMS Solution Exaquantum/Batch Excel add-in Slide 74 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 74 Excel add-in Functionality Slide 75 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 75 Excel add-in Batch Data Selector Slide 76 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 76 Excel add-in Trend Data Selector Slide 77 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 77 Excel add-in Query Wizard Slide 78 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 78 Excel add-in Report Slide 79 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 79 Yokogawa PIMS Solution Exaquantum/Batch 21 CFR Part 11 Slide 80 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 80 Requirements & Design Requirements reviewed with European pharmaceutical company GAMP 4 Guide, Validation of Automated Systems, December 2001. ISPE and PDA, Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures, Version 1, September 2001 Reid and Mullendore, Electronic Records and Electronic Signatures Compliance Assessment, published 2001 Designed for 21 CFR Part 11 Slide 81 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 81 Stelex Inc. USA Validation consultants Yokogawa has on-going relationship Darwin product design consultation & whitepaper for compliance with Part 11 Performed Part 11 gap analysis on Exaquantum/Batch design Whitepaper on using in a regulated environment will be available after release Designed for 21 CFR Part 11 Slide 82 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 82 Stelex Gap Analysis Report Slide 83 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 83 Access control Windows 2000 security Operators cannot change data Audit trail Operational changes recorded in database Electronic records All database contents potentially an electronic record Electronic signatures Uses Windows 2000 account name & password Help system Documents Part 11 support Part 11 Support Slide 84 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 84 Part 11 Access Control Windows 2000 domain security Account must be given right to access feature Users may be individually assigned rights or grouped together Operators 1 and 2 may each be given access to BatchWeb and permitted to enter formula result values (or) Operators 1 and 2 may be added to the operator group which has these two rights Examples of rights Access BatchWeb Run reports Manually enter formula values Approve reports Manually create new formula items Create & edit report templates Approve manual formula value entries Approve templates Slide 85 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 85 Access Control Options Privilege (Group) QuantumUser Super User User1 Engineer User2 Supervisor User3 Operator User4 No Access QAdministratorGroupXX QBBatchWebUserXXXX QBReportApproveXX QBReportRunXXX QBReportTmplApproveXXX QBTrendTmplAdminXXX Configurable for each project Slide 86 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 86 Part 11 Audit Trail Recorded in audit trail Operational manual activities Some configuration activities Electronic signatures System events Start/stop Configuration changes Audit trail viewer Excel reports used to view audit trail View entries in a time period Export entries to CSV (comma separate value) file for use in spreadsheet or database Audit Trail Contents Operational manual activities When (timestamp) Who (full user name, not account name) Why (user enters reason) Where (Computer name captured) What (old value preserved) Slide 87 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 87 Part 11 - Electronic Records (1 of 2) Identification of electronic records is specific to each application Possible Exaquantum/Batch electronic records Batch data Master recipe data Equipment data Trends Alarms & Events Reports Slide 88 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 88 Part 11 - Electronic Records (2 of 2) Stored securely limited access Archived for long-term storage Automatically collected data May be validated Changed formula values not overwritten Save each changed value with timestamp Property value changes recorded in audit trail Manual entries Require electronic signature Record in audit trail Slide 89 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 89 Part 11 - Electronic Signature Applied using account name & password Uses Windows 2000 domain accounts & passwords Required for: Formula value changes Adding new formula items Approving report templates Approving report output Entry of manual performance rating Signature manifest pop-up window Provides information about electronic signatures Satisfies 11.50 Signature manifestations Slide 90 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 90 Yokogawa PIMS Solution Yokogawa Quality Assurance Slide 91 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 91 The Yokogawa Philosophy Corporate Philosophy(1915) Quality First Pioneer Spirit Contribution to Society Corporate Philosophy As a company, our goal is to contribute to society through broad ranging activities in the areas of measurement, control, and information. Individually, we aim to combine good citizenship with the courage to innovate. Quality Policy Quality First for Customer Satisfaction Slide 92 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 92 Corporate Quality Policy The purpose of quality assurance is to achieve customer satisfaction, to obtain their confidence, and to respond to social requirements. Quality Assurance is one of the basic management goals Yokogawa Quality System conforms to ISO9000s Yokogawa accomplishes Quality Assurance through the accumulation of all functions and organizations Each manager is responsible for the quality of his/her assignment From Company code No.4-02 (replaced by QS-100) Slide 93 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 93 Quality Assurance History of QA Activities ISO9001 Certificate.1992 ISO14001 Certificate.1998 70 80 90 2000 Divisional QA Dept. QC Circle Corporate QA Dept. Corporate QA Manual ETS Quality Management ISO9001:2000, QMS2000 Slide 94 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 94 Worldwide Business Operations Yokogawa's global network of 29 manufacturing facilities, 101 affiliate companies with over 500 sales and engineering offices spanning 28 countries Headquarters Regional Headquarters Production Facilities Sales, Engineering and Service Centers Product Development Locations Slide 95 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 95 Formed in 1966 as Marex Established formal QA Standards to meet requirements working for companies like Shell, BP, Amoco and Sabic System integration Dedicated to the process industry Promace Plant Information Management System (PIMS) released in 1989 1997 acquired by Yokogawa Electric Corporation Japan and named Yokogawa Marex Designed and Implemented Exaquantum (2000) and Exaquantum/Batch (2003) Yokogawa Marex Slide 96 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 96 1995 gained ISO9001:1994 Certification (replaced BS5750) 1998 re-certified to ISO9001:1994 2001 Certified to new Standard - ISO9001:2000 First Yokogawa Group to achieve 9001:2000 Certification One of the first in the UK 2002 Quality program moved to the intranet Replaced paper-based quality system Yokogawa Marex QA History Slide 97 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 97 Yokogawa PIMS Solution Exaquantum/Batch Benefits Slide 98 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 98 Features designed to make regulatory compliance easier Built in Part 11 support Access control Report package data integrity Decrease costs of batch record keeping Consolidate records into central repository Standard data access Long-term storage Reduce validation costs Automatic data collection = less configuration to validate Single vendor solution = fewer interfaces Regulatory Benefits Slide 99 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 99 Lower TCO of batch record keeping Minimize upfront installation & engineering costs Decrease on-going production record keeping costs Improve production efficiency by easily monitoring actual cycle times for batches & products Improve plant capabilities by finding equipment bottlenecks and trouble spots using BatchWeb and reporting functions Business Benefits (1) Slide 100 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 100 Enable more accurate forecasting by using historical cycle time data Give production visibility to all plant personnel and enterprise systems Deliver better information to decision makers Business Benefits (2) Slide 101 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 101 Automatically collects batch, master recipe, equipment data Reporting platform Automatic analysis features Use to improve production Contribute to Six Sigma programs Web based data browsing Secure web access to production data In Conclusion Slide 102 Copyright Yokogawa Electric Corporation February 7th, 2006 Exaquantum/Batch Page 102 Close Out Any Questions?