Batch Plant Information Management For Pharmaceutical Industries R1.02

Batch Plant Information Management For Pharmaceutical Industries R1.02
Saturday, April 22, 2017

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 Exaquantum/Batch

Yokogawa’s 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 Exaquantum/Batch

Yokogawa PIMS Solution
Exaquantum/PIMS Plant Information Management System Exaquantum/Batch

Exaquantum Architecture
Exaquantum/Web Clients Exaquantum/Explorer Clients Web Server Intranet Local Area Network Long-term Archive Role Based View Historian Administration Tool External data: ERP, LIMS, CMMS, etc. Real Time Database PCS Interface Exaquantum/PIMS Server OPC Servers, DCSs, PLCs, etc. Exaquantum/PIMS Server Exaquantum/PIMS Server Plant Exaquantum/Batch

Typical Exaquantum System
Exaquantum Server Exaquantum Clients Exaquantum/PIMS R supports: Yokogawa Exaopc for µXL, 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 Exaopc Station/HIS HIS Other OPC DA servers are available for: ABB Allen-Bradley AspenTech Bailey Eurotherm Fisher-Rosemount Intellution Moore plus others… CS 3000 FCS Exaquantum/Batch

Exaquantum Licenses Worldwide
Over 430 Exaquantum systems as of February 2005 Exaquantum/Batch

Exaquantum: Unique Features
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/Batch

Sophisticated OPC Client Capability Yokogawa DCS support includes:
Control System connectivity Sophisticated OPC Client Capability Yokogawa DCS support includes: CENTUM CS 1000/CS 3000 CENTUM CS CENTUM-XL CENTUM µXL 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 Exaquantum/Batch

Batch Plant Information Management System
Yokogawa PIMS Solution Exaquantum/Batch Batch Plant Information Management System Exaquantum/Batch

Extensions to Exaquantum to serve batch process industry
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 Purpose of the meeting Demonstrate E/B Collect data Print report Historical batch data Batch Trend E/B currently in test Demo system does not have every function enabled Some functions not fully optimized in this installation For example data collection is purposely slowed down for development purposes Batch data can be collected in < 1 sec., demo installation takes 3-5 minutes for debug purposes Exaquantum/Batch

Traditional PIMS are lacking when used in batch applications
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 Exaquantum/Batch

Exaquantum + Batch = Exaquantum/Batch
Batch Web Clients Batch Web Clients Web Server Intranet Local Area Network Long-term Archive Batch Database Role Based View Historian Administration Tool External data: ERP, LIMS, CMMS, etc. Real Time Database PCS Interface Exaquantum/PIMS Server OPC Servers, DCSs, PLCs, etc. Exaquantum/PIMS Server Exaquantum/PIMS Server Plant Exaquantum/Batch

Providing users with reports and analysis capabilities
Yokogawa Batch Solutions CS Batch 1000 CS Batch 3000 Providing users with reports and analysis capabilities Exaquantum/Batch Collecting: Master Recipes Batch/Control Recipe Data Equipment Configuration Alarm & Events Trend Data Master Recipe Storage Users Master Recipe Data Ethernet ENG HIS Batch Servers Dual Exaopc Servers V net Control Recipe Data Unit Supervision FCS Exaquantum/Batch

S88 – Production Information Management
Recipe Management Production Planning & Scheduling Production Information Management Process Management Unit Supervision Process Control Personnel & Environmental Protection Outside the scope of SP88 standard ProSafe Exaquantum/Batch

“When did we make batch B-4290” & “what equipment did it use?”
Questions, Questions, Questions … “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?” Exaquantum/Batch is designed to help plant personnel answer important production and product related questions. Exaquantum/Batch provides direct access to batches, units, and master recipes Data can be automatically collected Organized based upon s88 for easy access Standard displays enable uses to find the answers Master recipes used for each batch are saved To answer these questions with traditional tag/time based historians required considerable engineering to collect the data and engineering to create custom displays and/or expect users to have detailed knowledge of the application so that they could write queries or search for specific tags that contained values. Standard Exaquantum/Batch displays means that users can make immediate use of the collected data. Exaquantum/Batch

“How long does it usually take to make this product?”
… Questions, Questions, Questions “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?” Exaquantum/Batch is designed to help plant personnel answer important production and product related questions. Exaquantum/Batch provides direct access to batches, units, and master recipes Data can be automatically collected Organized based upon s88 for easy access Standard displays enable uses to find the answers Master recipes used for each batch are saved To answer these questions with traditional tag/time based historians required considerable engineering to collect the data and engineering to create custom displays and/or expect users to have detailed knowledge of the application so that they could write queries or search for specific tags that contained values. Standard Exaquantum/Batch displays means that users can make immediate use of the collected data. Exaquantum/Batch

Key Features Standard Analysis Data Web Browsing
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 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 “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 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 Exaquantum/Batch

Automatic Batch Data & Master Recipe collection
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 Exaquantum/Batch

Strong batch reporting platform
…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 Exaquantum/Batch

High level batch solutions coupled with batch control system
…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 Exaquantum/Batch

World Wide Web Consortium
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 Exaquantum/Batch

Microsoft SQL Server 2000 relational database
Commercial Off The Shelf Technology 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 Exaquantum/Batch

Functional Configuration
BatchWeb Client (IE6) Exaquantum/Batch BatchWeb Server Reporting Batch Data Browsing Basic Analysis Charts Clients Report Runtime Report Configuration On-line Configuration Utilities Batch Database Microsoft SQL Server Batch Metrics Calculations Custom Batch Data Collection Report Distribution - Hardcopy - - Print - Acrobat - Report Archive Exaquantum Historian (Trend & Event Data) Master Recipe Data Collection Automatic Batch Data Collection This has been updated per previous figure This shows how functional specs map into the figure The next slide lists the functional spec Batch Server Exaopc Batch DA & AE Server Exaopc OPC DA Server Exaopc Others CS Batch 1000/3000 Other PAS/MES Exaquantum/Batch

Control Recipe Data Equipment Master Recipes Trend Data Events
Data Collection Control Recipe Data Automatically collected – No Engineering, reduced Maintenance Via Exaopc Batch Server Equipment Plant hierarchy automatically collected 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 Automatically collect data from S-P process Batch Collection points: Reservation Batch & Unit Recipe start/end Batch deletion Track batch, unit recipe, operation status [possibly – not certain at this time] Master Recipe Collection Every revision to a master recipe that is loaded to the HIS Each batch is associated with the exact master recipe revision it is based on Equipment collection Will track changes in plant hierarchy (not in this demo) Trend & Event Collection Exaquantum Trend & Event collection Reduced Maintenance Exaquantum/Batch

Control Recipe Data Equipment Master Recipes Trend Data Events
High Data Availability 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 Exaquantum/Batch

Yokogawa’s OPC product line Supports OPC Foundation Specifications
Exaopc Yokogawa’s 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 DA A&E HDA Batch Exaquantum/Batch

Redundant OPC DA and A&E Servers
Exaquantum/Batch Exaquantum/Batch OPC Client Exaquantum/Batch Exaopc Server Exaopc Client Ethernet HIS & Batch Servers Exaopc Servers A B V-net Data Access Alarm & Event Unit Supervision Exaopc Server A Exaopc Server B FCS CS Batch 1000/3000 Exaquantum/Batch

Exaquantum/Batch OPC Client
Dual OPC Batch Servers Exaquantum/Batch Exaquantum/Batch Exaquantum/Batch OPC Client CS Batch 1000/3000 Ethernet His & Batch Servers Exaopc Servers A B V net Batch Unit Supervision Exaopc Server A Exaopc Server B FCS CS Batch 1000/3000 Exaquantum/Batch

Collects data via Exaopc Batch Server
Automatic Batch Data Collection… 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, …) Exaquantum/Batch

Exaquantum/Batch collects data throughout a batch:
…Automatic Batch Data Collection… 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 Exaquantum/Batch

…Automatic Batch Data Collection
Data Collected: Batch header data Batch ID Master Recipe ID Master Recipe Revision Start Time End Time Train/Path … Unit Recipe data Unit Start time Operations End Time Formula data All formula items are collected Formula ID Value Engineering Units Exaquantum/Batch

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 Exaquantum/Batch

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 Exaquantum/Batch

…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 Exaquantum/Batch

May be used with or without automatic data collection
Custom Batch Data Collection… 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 This provides a very flexible method to collect data. Projects can use Custom Batch Data Collection to collect data from just about any system. All data must first be collected by Exaquantum and then Exaquantum/Batch collects the values from the Exaquantum tags and writes it to the s88 based batch database. Exaquantum/Batch

Amount of data collected is variable
…Custom Batch Data Collection… 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) This provides a very flexible method to collect data. Projects can use Custom Batch Data Collection to collect data from just about any system. All data must first be collected by Exaquantum and then Exaquantum/Batch collects the values from the Exaquantum tags and writes it to the s88 based batch database. Exaquantum/Batch

…Custom Batch Data Collection
Trigger: TTT Item 1: XXX Item 2: YYY Item 3: ZZZ Trend Database PAS / Lab System Tag TTT OPC DA Server Manual Entry Dialog Tag XXX Tag YYY Equipment Hierarchy Data Tag ZZZ Batch Database Batch Data Exaquantum Graphics Batch Properties Formula Unit Recipe Operation This shows the flow of data when custom batch data collection is used. Manually Entered Data Exaquantum/Batch

Exaquantum/Batch BatchWeb Exaquantum/Batch

Web based user interface – ‘BatchWeb’
BatchWeb Features 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 To view reports on the BatchWeb, client PCs will require Adobe Acrobat Reader 5.0. Exaquantum/Batch

Automatically generated charts
BatchWeb Features Standard, preformatted displays for browsing of batch, equipment & master recipe data without configuration of displays Automatically generated charts Cycle time Performance Ratings Gantt Charts To view reports on the BatchWeb, client PCs will require Adobe Acrobat Reader 5.0. Exaquantum/Batch

Dynamically Built Web Pages
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’ BatchWeb Applications Web Page Layouts Yokogawa Framework Web Server (IIS) The BatchWeb application is built on top of the Tropicana framework. Users will not see Tropicana as a separate function, they will view everything as Exaquantum/Batch BatchWeb user interface. Batch Database Exaquantum Trend Database Exaquantum Event Database Exaquantum/Batch

Basic Display Layout Standard Functions Application View Area
The application view is Icecap specific. The standard Tropicana Functions are customized for Icecap. Exaquantum/Batch

BatchWeb Layout Main Menu Select data catagory Related Views
Select application view Filter Set conditions to adjust view data scope MyList Select item for personalized view Batch List Select particular batches to call up detail views Exaquantum/Batch

Data Scope filters data by time and content
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 Batch Master Recipe Unit Performance Rating Campaign Exaquantum/Batch

Formula Items Exaquantum/Batch

Batch Summary Each view displays data for 1 batch
Drop down list automatically populated from selected batches Exaquantum/Batch

Batch & unit recipe start/end times indicated on trend
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 Exaquantum/Batch

Batch Trend Chart Selection
Batch trend charts may be saved – called templates Users may add, edit and delete charts Exaquantum/Batch

Batch Trend Exaquantum/Batch

Batch Trend View Design
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 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 Batch & Unit Recipe Flags: Indicate start/end of unit recipes using tags Exaquantum/Batch

Batch Trend Template Specification explains how aliases may be used to assign unit relative tags Up to 6 tags or aliases may be assigned to a chart template Exaquantum/Batch

Automatically generated Cycle time
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 Exaquantum/Batch

Cycle Time Chart Example
Cycle Time per Batch Cycle Time Frequency Distribution 10 20 30 40 50 60 B-1 B-2 B-3 B-4 B-5 B-6 B-7 B-8 B-9 B-10 Batch IDs Hours 5 10 15 20 25 30 35 40 45 50 27 28 29 31 32 33 34 36 37 38 39 41 Cycle Time in Hours Number of Batches Narrow distribution of batches within standard deviation Eliminate outlaying performance Refine data sets Find individual batch IDs Starting point to drill down Overview of performance Visualizes variability around mean Compare before & after counter-measures to find improvements Narrower set of peaks is best Exaquantum/Batch

Cycle Time Chart Exaquantum/Batch

Performance Rating Chart
Each Bar = 1 Batch Y Axis = Performance Rating Red Bars indicate automatic performance values manually overridden Exaquantum/Batch

Gantt Chart showing absolute time
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 Exaquantum/Batch

Batch Gantt Chart showing absolute time
Exaquantum/Batch

Batch Gantt Chart showing relative time
Exaquantum/Batch

Common, non-batch specific events may be included
Batch Event View Table of events Filter by event type Common, non-batch specific events may be included Absolute or batch relative timestamps Exaquantum/Batch

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 Exaquantum/Batch

Exaquantum/Batch Reporting Exaquantum/Batch

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 Exaquantum/Batch

Excel based reporting package
Batch Reporting… Excel based reporting package Excel is wrapped with an Exaquantum/Batch reporting application Virtually unlimited amount of data items per report Exaquantum/Batch

All data in relational database available for custom reports
…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 Exaquantum/Batch

Batch Report Process Flow
Create/modify template Approve template Set report options Report Template Management Excel Templates stored in database, not directly accessible to Excel users Report Templates XLS Batch Data Collection Run report at Batch/Unit Recipe End Batch Database Report Runtime Exaquantum Excel distribution of reports Run reports daily, weekly or monthly BatchWeb View reports Run reports Approve reports Check in/out Excel file Report Archive PDF XLS Exaquantum/Batch

Report Template Management
User defined report template groups and reports All versions of report templates preserved Report template options Exaquantum/Batch

Standard tools for building reports
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 Database access with Microsoft Query In template queries are defined At runtime results of queries are placed in report output Exaquantum/Batch

Use common Microsoft tools for building queries
… Microsoft Query Icecap Database contains special View tables for simpler access to data Use common Microsoft tools for building queries Database access with Microsoft Query In template queries are defined At runtime results of queries are placed in report output Exaquantum/Batch

Scheduled Reports Manually Running 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 Exaquantum/Batch

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 Exaquantum/Batch

Report stored in archive Report Approval Report output may be
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 ed to distribution list Stored for future use Exaquantum/Batch

Exaquantum/Batch Excel add-in Exaquantum/Batch

Excel add-in Functionality
Exaquantum/Batch

Excel add-in Batch Data Selector
Exaquantum/Batch

Excel add-in Trend Data Selector
Exaquantum/Batch

Excel add-in Query Wizard
Exaquantum/Batch

Excel add-in Report Exaquantum/Batch

Exaquantum/Batch 21 CFR Part 11 Yokogawa PIMS Solution

Requirements & Design Designed for 21 CFR Part 11…
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 Exaquantum/Batch

Stelex Inc. …Designed for 21 CFR Part 11 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 Exaquantum/Batch

Stelex Gap Analysis Report
Exaquantum/Batch

Electronic signatures
Part 11 Support 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 Exaquantum/Batch

Windows 2000 domain security
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 Exaquantum/Batch

Access Control Options
Configurable for each project Privilege (Group) QuantumUser Super User User1 Engineer User2 Supervisor User3 Operator User4 No Access QAdministratorGroup X QBBatchWebUser QBReportApprove QBReportRun QBReportTmplApprove QBTrendTmplAdmin Exaquantum/Batch

Recorded in audit trail
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) Exaquantum/Batch

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 Exaquantum/Batch

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 Exaquantum/Batch

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 § Signature manifestations Exaquantum/Batch

Quality Assurance Exaquantum/Batch

The Yokogawa Philosophy Corporate Philosophy(1915) Quality Policy
Quality First Pioneer Spirit Contribution to Society Quality Policy Quality First for Customer Satisfaction 　 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. Exaquantum/Batch

Corporate Quality Policy
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 The purpose of quality assurance is to achieve customer satisfaction, to obtain their confidence, and to respond to social requirements. From Company code No.4-02 (replaced by QS-100) Exaquantum/Batch

History of QA Activities
Quality Assurance ISO9001:2000, QMS2000 ETS Quality Management ISO9001 Certificate .1992 ISO14001 Certificate .1998 Corporate QA Dept. Corporate QA Manual Divisional QA Dept. QC Circle ‘ ’ ‘ Exaquantum/Batch

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 Exaquantum/Batch

‘Promace’ Plant Information Management System (PIMS) released in 1989
Yokogawa Marex 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) Exaquantum/Batch

1995 – gained ISO9001:1994 Certification (replaced BS5750)
Yokogawa Marex QA History 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 Exaquantum/Batch

Exaquantum/Batch Benefits Exaquantum/Batch

Features designed to make regulatory compliance easier
Regulatory Benefits 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 Exaquantum/Batch

Lower TCO of batch record keeping
Business Benefits (1) 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 Exaquantum/Batch

Enable more accurate forecasting by using historical cycle time data
Business Benefits (2) 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 Exaquantum/Batch

Automatically collects batch, master recipe, equipment data
In Conclusion 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 Exaquantum/Batch

Close Out Any Questions? Exaquantum/Batch

Batch Plant Information Management For Pharmaceutical Industries R1.02

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