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Page 1: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Copyright © Yokogawa Electric CorporationMar 4th, 2005

Wednesday, April 19, 2023

Batch Plant Information Management For Pharmaceutical Industries R1.02

Page 2: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 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

Page 3: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 4: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 4Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/PIMSPlant Information

Management System

Page 5: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 6: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 7: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 7Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Exaquantum Licenses Worldwide

Over 430 Exaquantum systems as of February 2005

Page 8: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 9: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 10: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 10Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/BatchBatch Plant InformationManagement System

Page 11: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 12: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 13: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 14: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 15: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 16: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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 …

Page 17: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 18: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 19: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 20: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 21: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 22: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 23: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 24: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 25: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 26: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 27: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 28: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 29: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 30: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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…

Page 31: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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…

Page 32: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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…

Page 33: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 34: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 35: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 36: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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…

Page 37: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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…

Page 38: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 39: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 39Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/BatchBatchWeb

Page 40: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 41: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 42: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 43: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 43Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Basic Display Layout

Standard Functions

Application View Area

Page 44: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 45: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 46: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 46Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Formula Items

Page 47: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 48: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 49: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 49Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Batch Trend Chart Selection

Page 50: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 50Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Batch Trend

Page 51: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 52: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 52Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Batch Trend Template

Page 53: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 54: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

Page 55: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 55Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Cycle Time Chart

Page 56: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

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

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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

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Exaquantum/Batch Page 58Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Batch Gantt Chart showing absolute time

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Exaquantum/Batch Page 59Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Batch Gantt Chart showing relative time

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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

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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

Page 62: Copyright © Yokogawa Electric Corporation Mar 4 th, 2005 Sunday, September 20, 2015 Batch Plant Information Management For Pharmaceutical Industries R1.02

Exaquantum/Batch Page 62Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/BatchReporting

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Exaquantum/Batch Page 73Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/BatchExcel add-in

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Exaquantum/Batch Page 74Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Excel add-in Functionality

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Exaquantum/Batch Page 75Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Excel add-in Batch Data Selector

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Excel add-in Trend Data Selector

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Exaquantum/Batch Page 77Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Excel add-in Query Wizard

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Exaquantum/Batch Page 78Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Excel add-in Report

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Exaquantum/Batch Page 79Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/Batch21 CFR Part 11

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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…

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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

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Exaquantum/Batch Page 82Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Stelex Gap Analysis Report

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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

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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

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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

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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)

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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

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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

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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

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Exaquantum/Batch Page 90Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

YokogawaQuality Assurance

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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

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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)

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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

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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

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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

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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

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Exaquantum/Batch Page 97Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Yokogawa PIMS Solution

Exaquantum/BatchBenefits

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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

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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)

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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)

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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

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Exaquantum/Batch Page 102Copyright © Yokogawa Electric CorporationFeb 4th, 2005

Close Out

Any Questions?