Copyright © Yokogawa Electric CorporationMar 4th, 2005
Wednesday, April 19, 2023
Batch Plant Information Management For Pharmaceutical Industries R1.02
Exaquantum/BatchCopyright © Yokogawa Electric CorporationFeb 4th, 2005
PIMS Requirements
Operators
ProcessTechnologists
Managers
QualityAssurance
Scheduling& Planning
Production
Integratedverified timely
information
Company Objectives
Increase productivityRaise performanceReduce costs
Regulatory compliance
Improve qualityReduce decisiontimeMeet standardsImproveefficiencyReducedowntime
Sharedperspective
&common
goal
Moreawareness &
reducedconfusion
Easy dataaccess &
management
Increase profits
Process Information
Data Control
PlantInformation
Exaquantum/Batch Page 3Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 4Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/PIMSPlant Information
Management System
Exaquantum/Batch Page 5Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Exaquantum/PIMS Server
Exaquantum/PIMS Server
Exaquantum Architecture
Exaquantum/Explorer Clients
Exaquantum/Web Clients
Intranet Local 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
Exaquantum/Batch Page 6Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Typical Exaquantum System
CS 3000 FCS
Exaquantum Server Exaquantum Clients
Exaopc Station/HIS HISOther 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 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
Exaquantum/Batch Page 7Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Exaquantum Licenses Worldwide
Over 430 Exaquantum systems as of February 2005
Exaquantum/Batch Page 8Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 9Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Control System connectivity
Exaquantum/Batch Page 10Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/BatchBatch Plant InformationManagement System
Exaquantum/Batch Page 11Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 12Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 13Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Exaquantum/PIMS Server
Exaquantum/PIMS Server
Exaquantum + Batch = Exaquantum/Batch
Batch Web ClientsBatch Web Clients
Intranet Local 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
Exaquantum/Batch Page 14Copyright © Yokogawa Electric CorporationFeb 4th, 2005
V net
Ethernet
FCS
Unit Supervision
Master RecipeStorage
Collecting:– Master Recipes– Batch/Control Recipe Data– Equipment Configuration– Alarm & Events– Trend Data
CS Batch 1000 CS Batch 3000 Exaquantum/Batch
Dual ExaopcServers
Yokogawa Batch Solutions
Users
Providing users with reports and analysis
capabilities
Control Recipe Data
Master Recipe Data
ENGHIS BatchServers
Exaquantum/Batch Page 15Copyright © Yokogawa Electric CorporationFeb 4th, 2005
S88 – Production Information Management
Outside the scopeof SP88 standard
RecipeManagement
RecipeManagement
ProductionPlanning &Scheduling
ProductionPlanning &Scheduling
ProductionInformation
Management
ProductionInformation
Management
ProcessManagement
ProcessManagement
Personnel &Environmental
Protection
Personnel &Environmental
Protection
ProcessControlProcessControl
UnitSupervision
UnitSupervision
ProSafe
Exaquantum/Batch Page 16Copyright © Yokogawa Electric CorporationFeb 4th, 2005
“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 …
Exaquantum/Batch Page 17Copyright © Yokogawa Electric CorporationFeb 4th, 2005
“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
Exaquantum/Batch Page 18Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 & be
nefit without cumbersome configuration– Automatically adapts to application configuration cha
nges– 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
Exaquantum/Batch Page 19Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 20Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…Features…
Strong batch reporting platform– Batch, master recipe & equipment data available for any repor
t
– 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 Page 21Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…Features
High level batch solutions coupled with batch control system– Traditional Time & Tag based PIMS no longer sufficient for ba
tch solutions
– High performance & great value
Powerful Exaquantum/Batch Excel add-in
Exaquantum/Batch Page 22Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 23Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 24Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch DatabaseMicrosoft
SQL Server
Batch ServerExaopc Batch
DA & AE ServerExaopc
Master RecipeData Collection
Batch Metrics Calculations
AutomaticBatch DataCollection
Report Distribution- Hardcopy- e-mail- Print- Acrobat- Report Archive
CustomBatch Data
Collection ExaquantumHistorian
(Trend & Event Data)
CS Batch 1000/3000
On-lineConfiguration
Utilities
Report Configuration
Report Runtime
Functional Configuration
BatchWebClient (IE6)
Exaquantum/Batch
OPC DA ServerExaopc Others
Other PAS/MES
BatchWeb Server
ReportingBatch DataBrowsing
BasicAnalysisCharts
Clie
nts
Exaquantum/Batch Page 25Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 26Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 27Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 28Copyright © Yokogawa Electric CorporationFeb 4th, 2005
V-net
Ethernet
FCS
Unit Supervision
HIS & BatchServers
Exaquantum/Batch
ExaopcServers A B
Exaquantum/Batch
Exaopc Server
A
Exaopc Client
Exaquantum/Batch OPC Client
Exaopc Server
Data AccessAlarm & Event
Redundant OPC DA and A&E Servers
Exaopc Server
B
CS Batch 1000/3000
Exaquantum/Batch Page 29Copyright © Yokogawa Electric CorporationFeb 4th, 2005
V net
Ethernet
FCS
Unit Supervision
His & BatchServers
Exaquantum/Batch
ExaopcServers A B
Exaquantum/Batch
Exaopc Server
A
Exaquantum/Batch OPC Client
Batch
Dual OPC Batch Servers
Exaopc Server
B
CS Batch 1000/3000
CS Batch 1000/3000
Exaquantum/Batch Page 30Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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…
Exaquantum/Batch Page 31Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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…
Exaquantum/Batch Page 32Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…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 dataUnit Start time Operations End Time…
– Formula dataAll formula items are collectedFormula ID Value Engineering
Units…
Exaquantum/Batch Page 33Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 34Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 35Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…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 Page 36Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 structuresMay be used with or without automatic data collection
Custom Batch Data Collection…
Exaquantum/Batch Page 37Copyright © Yokogawa Electric CorporationFeb 4th, 2005
All data stored in relational database in same format and capabilities as with automatic data collectionAmount 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…
Exaquantum/Batch Page 38Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…Custom Batch Data Collection
OPC
DA
Serv
er
Tag TTT
Trend Database
Batch Database
PA
S / La
b S
yste
m
Tag XXX
Tag YYY
Tag ZZZ
Exaquantum
Graphics Manually Entered Data
Equipment Hierarchy Data
BatchPropertiesFormula
PropertiesUnit Recipe
PropertiesFormula
PropertiesOperation
PropertiesFormula
Properties
Batch Data
Trigger: TTT Item 1: XXX Item 2: YYY Item 3: ZZZ
ManualEntry Dialog
Exaquantum/Batch Page 39Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/BatchBatchWeb
Exaquantum/Batch Page 40Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 41Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 42Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Dynamically Built Web Pages
BatchDatabase
Exaquantum
TrendDatabase
Exaquantum
EventDatabase
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
Exaquantum/Batch Page 43Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Basic Display Layout
Standard Functions
Application View Area
Exaquantum/Batch Page 44Copyright © Yokogawa Electric CorporationFeb 4th, 2005
BatchWeb Layout
Related ViewsSelect application view
MyListSelect item for personalized view
Batch ListSelect particular batches to call up detail views
Filter Set conditions to adjust view data scope
Main MenuSelect data catagory
Exaquantum/Batch Page 45Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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/yearsSince start of
week/month/year
– By ContentBatch Master Recipe
Unit Performance Rating
Campaign
Exaquantum/Batch Page 46Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Formula Items
Exaquantum/Batch Page 47Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Summary
Each view displays data for 1 batch
Drop down list automatically populated from selected batches
Exaquantum/Batch Page 48Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 49Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Trend Chart Selection
Exaquantum/Batch Page 50Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Trend
Exaquantum/Batch Page 51Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 52Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Trend Template
Exaquantum/Batch Page 53Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Analysis Views
Automatically generatedCycle 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 Page 54Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Cycle Time per Batch
0
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-1
0
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 HoursN
um
ber
of
Batc
hes
Eliminate outlaying performance
Exaquantum/Batch Page 55Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Cycle Time Chart
Exaquantum/Batch Page 56Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Performance Rating Chart
Red Bars indicate automatic performance values manu
ally overridden
Each Bar = 1 BatchY Axis = Performance Ratin
g
Exaquantum/Batch Page 57Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 58Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Gantt Chart showing absolute time
Exaquantum/Batch Page 59Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Gantt Chart showing relative time
Exaquantum/Batch Page 60Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Event View
Table of eventsFilter by event typeCommon, non-batch specific events may be includedAbsolute or batch relative timestamps
Exaquantum/Batch Page 61Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Unit Utilization Chart
Gantt chart showing when each unit was used by a batch/unit recipeUnit recipes in same batch are in the same colorGraphically conveys unit utilizationCorresponding table view
Exaquantum/Batch Page 62Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/BatchReporting
Exaquantum/Batch Page 63Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 64Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 65Copyright © Yokogawa Electric CorporationFeb 4th, 2005
…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 Page 66Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Batch Report Process Flow
XLSBatch DataCollection
BatchWeb
– 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 DatabaseReport Runtime
Excel
PDFXLS
Report Archive
Exaquantum/Batch Page 67Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Report Template Management
User defined report template groups
and reports
All versions of report templates preserved
Report template options
Exaquantum/Batch Page 68Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Microsoft Query…
Standard tools for building reportsMS Query instruction can be found in local languages & classesBuild custom queries to suit business needsIT trained personnel able to build reports
Exaquantum/Batch Page 69Copyright © Yokogawa Electric CorporationFeb 4th, 2005
… Microsoft Query
Icecap Database contains special View
tables for simpler access to data
Use common Microsoft tools for building
queries
Exaquantum/Batch Page 70Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 71Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 72Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Report Viewer
Adobe Acrobat filesOptions to– Restrict changes– Require approval
Report stored in archiveReport Approval Report output may be– Viewed on web– Printed– E-mailed to distribution list– Stored for future use
Exaquantum/Batch Page 73Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/BatchExcel add-in
Exaquantum/Batch Page 74Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Excel add-in Functionality
Exaquantum/Batch Page 75Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Excel add-in Batch Data Selector
Exaquantum/Batch Page 76Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Excel add-in Trend Data Selector
Exaquantum/Batch Page 77Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Excel add-in Query Wizard
Exaquantum/Batch Page 78Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Excel add-in Report
Exaquantum/Batch Page 79Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/Batch21 CFR Part 11
Exaquantum/Batch Page 80Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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…
Exaquantum/Batch Page 81Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 82Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Stelex Gap Analysis Report
Exaquantum/Batch Page 83Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 84Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 85Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Access Control Options
Privilege(Group)
QuantumUser
Super User
User1Enginee
r
User2Superviso
r
User3Operato
r
User4No
Access
QAdministratorGroup
X X
QBBatchWebUser X X X X
QBReportApprove X X
QBReportRun X X X
QBReportTmplApprove
X X X
QBTrendTmplAdmin X X X
Configurable for each project
Exaquantum/Batch Page 86Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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 Page 87Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Part 11 - Electronic Records (1 of 2)
Identification of electronic records is specific to each applicationPossible Exaquantum/Batch electronic records– Batch data– Master recipe data– Equipment data– Trends– Alarms & Events– Reports
Exaquantum/Batch Page 88Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Part 11 - Electronic Records (2 of 2)
Stored securely – limited accessArchived – for long-term storageAutomatically 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 Page 89Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 90Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
YokogawaQuality Assurance
Exaquantum/Batch Page 91Copyright © Yokogawa Electric CorporationFeb 4th, 2005
The Yokogawa Philosophy
Corporate Philosophy(1915)Quality FirstPioneer SpiritContribution to Society
Corporate PhilosophyAs 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 PolicyQuality First for Customer Satisfaction
Exaquantum/Batch Page 92Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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)
Exaquantum/Batch Page 93Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Qu
alit
y A
ssu
ran
ceHistory of QA Activities
ISO9001 Certificate .1992ISO14001 Certificate .1998
‘70 ’80 ‘90 2000
Divisional QA Dept.QC Circle
Corporate QA Dept.Corporate QA Manual
ETS Quality Management
ISO9001:2000, QMS2000
Exaquantum/Batch Page 94Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Worldwide Business Operations
Yokogawa's global network of 29 manufacturing facilities,101 affiliate companies with over 500 salesand engineering offices spanning 28 countries
Headquarters
Regional Headquarters
Production Facilities
Sales, Engineering and Service Centers
Product Development Locations
Exaquantum/Batch Page 95Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 96Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 97Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Yokogawa PIMS Solution
Exaquantum/BatchBenefits
Exaquantum/Batch Page 98Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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
Exaquantum/Batch Page 99Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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)
Exaquantum/Batch Page 100Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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)
Exaquantum/Batch Page 101Copyright © Yokogawa Electric CorporationFeb 4th, 2005
Automatically collects batch, master recipe, equipment dataReporting platformAutomatic analysis features– Use to improve production– Contribute to Six Sigma programs
Web based data browsing– Secure web access to production data
In Conclusion
Exaquantum/Batch Page 102Copyright © Yokogawa Electric CorporationFeb 4th, 2005
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