MESISPE

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Manufacturing Execution System (MES) Global
Validation Roll out
ISPE/LASM Winnipeg, MB Arman Rais-Firouz 09-April
-2008
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Agenda

• MES Background
• Commissioning Validation
• Multiple Site Implementation
• Q A

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BACKGROUND
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Corporate Systems

Business Systems
ERP, E-Commerce
CRM LIMS, WMS, eDMS
Information Management Systems
MRP/II MES
Manufacturing Systems
Shop Floor Control Systems DCS, SCADA, Vision
Systems
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MES Integration - Processes

• Planning
• Order Management
• Manufacturing
• Inspection
• Material Movement/Warehousing

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Integrated Business Processes
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MES Integration - Systems

• Business system ERP, MRP
• Material Storage Movement WMS, ASRS, AGV
• Quality Inspection LIMS
• Shop floor control SCADA, DCS
• Other HR, BMS, eDMS, CAPA

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MES Integration - Equipment

• Equipment SCADA
• Mixers, Coaters, Dispensing,
• Scales
• Vision Systems
• Alarms and Events

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Application Modules

• Master Batch Record
• Master data
• Execution
• EBR, Weighing Dispensing, Material tracking,
  WMS, Line Control
• Quality Control
• Deviation Event Management, CAPA
• Monitoring and Optimization
• KPI

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Master Batch Records
Master Batch Records

• Basic Operation
• eg
• Manual Dispensing
• Automatic Dispensing
• Granulation
• Blending
• Compression
• Coating
• Sorting
• Inspection

Basic Function Dock Workroom release Completenes
s check Yield weighing Residual cleaning
Technical Function (SFO execution) Attributive Me
asuring Value Container Bundle Order
info Date Formula Etc.
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VALIDATION COMMISSIONING
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Validation Concept
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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-end Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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Validation Plan

• Description
• Scope
• Roles Responsibilities
• Applicable Regulations
• Methodology
• Project Plan
• Deliverables
• Quality Check Metrics

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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-end Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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Risk Assessment High Level

• Perform GxP/Part 11 assessment at system/Process
  level
• Limit the validation Scope to those processes
  only
• Use SISPQ as guideline for GxP Impact
• Safety,
• Identity,
• Strength,
• Purity,
• Quality

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Risk Assessment - Functional

• Perform functional level Risk Assessment to
  determine level of testing for each function
  (sub-process).
• Determine combined risk factor for each by
  Consider all the following risk factors
• Regulatory Impact (GxP, SOX)
• Business Criticality
• Likelihood of Occurrence
• Detect-ability on Failure
• Severity of Consequence

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Risk Level - Testing Level

• RISK LEVEL
• Low
• Medium
• High

• TESTING CHALLENGE
• No Testing !!
• Positive Testing
• Negative Testing
• Null Testing
• Limit Testing

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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-end Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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IT Infrastructure
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Installation Qualification

• Infrastructure
• Data Centre
• Network (WAN, LAN, WLAN, RF)
• SAN
• Servers (any used for production and formal
  testing)
• Application Servers(s)
• Data Base Server(s)
• Desktop Clients
• Mobile terminals
• Printers
• Scanners

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Installation Qualification

• MES Applications
• Interfaces
• SCADA (Recipe Name, Start, Stop, .)
• ERP (Order Info, Lot No., Item Master, )
• WMS (Location, Movement)
• LIMS (Lot, sample ID, Status, )
• BMS (Room, Equipment, )

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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-end Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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Operation Qualification (OQ)

• Functional OQ based on FRS using Risk based
  approach
• Interface OQ (If interface is not available,
  simulation is used)
• Data Migration OQ (May be in different phases,
  i.e. for PQ and for Go-Live)
• Application Security OQ (User access, segregation
  of duties, ERES)

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Acceptance Testing

• FAT Factory Acceptance Testing
• Unit level testing
• SAT Site Acceptance Testing
• Unit and Integration level testing
• UAT User Acceptance Testing
• Process level testing

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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-2-End Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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Performance Qualification (PQ)

• Pre go-live (PQ-1)
• End to end business process PQ
• Based on URS
• Stress testing
• Post go live monitoring (PQ-2)
• Time or order based monitoring of the system
• Allows for closure of open items at go-live

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Mapping of Test Activities

• Acceptance
• FAT
• SAT
• UAT

Test scripts Unit Integration1 Scenario2

• Qualification
• IQ
• OQ
• PQ

Notes 1. Integration Test script Multiple
Unit Test Scripts 2. Scenario Test script
Multiple Integration Test Scripts
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MES Landscape Qualification Requirements
Production Instance
Testing Instance
Development Instance
IQ No Yes
Yes
OQ No Yes
No
PQ No No
Yes
Controlled Environment
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Deliverables

• Validation Plan
• Risk Assessment
• IQ (including Network)
• OQ
• GxP Functionalities
• Security
• Data Migration
• PQ
• Stress Testing
• End-end Business Process verification
• Pre/post go-live

• Document Management Procedure
• Project Change Management
• Configuration Management
• Cutover Plan
• Data Migration Plan
• User Access
• Post go-live support
• Disaster Recovery/BCP
• SOPs

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Cutover Considerations

• Plan well ahead (many months)
• Meet Demand
• Ramp down Business, (Close open items, Notify
  customers)
• Cutover Activities
• Go-Live
• Business Ramp up

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Cutover Planning
Go Live
Volume
E
B
D
C
A
TIME
A Current Business volume, B Business ramp up
(Stock pile) C Productivity Dip toward
shutdown, D Controlled Business ramp up, E
Stabilization
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MES VALIDATION Multiple Site Implementation
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Multiple Site Implementation

• Global Template
• You need standard processes
• Define a global core (common to all sites)
  application template
• Develop, test and qualify this common template
• URS, RA, FRS, DS, Global VP,

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Global Template Validation
Change control
URS and VP may be reversed
Global Validation Report(VR)
Global Validation Plan
Global BP Global URS
Performance Qualification(PQ2)
SOPs
Training records
PQ Not used for template
Supplier Audit/ Part 11 assessment
Functional Specification Global (FS)
Global PQ
Global OQ
Hardware Software Design and Configuration
Specification
Installation Qualification (IQ)
Good Programming Practice Software Source Code
Review
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Site Specific Model
Change control
URS and VP may be reversed
Global Validation Report(VR)
Local Validation Plan
Local URS
Performance Qualification(PQ2)
SOPs
Training records
Local Interim Validation Report
Local FS
Local PQ PQ
Local OQ
Local DS
Installation Qualification (IQ)
Good Programming Practice Software Source Code
Review
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Multiple Site Implementation

• Local site roll out
• Determine site requirements
• Plan and execute validation activities for local
  features only (Do not need to test features that
  were already validated and will not be changed)
• Perform IQ
• OQ for Local features/enhancements that are
  different from the core
• PQ for local processes

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Electronic batch Record Paper Less
Master Batch Records

• Operation
• Manual Dispensing
• Automatic Dispensing
• Granulation
• Blending
• Compression
• Coating
• Sorting
• Inspection

Function Dock Workroom release Completeness
check Yield weighing Residual cleaning
Technical Function (SFO execution) Attributive Me
asuring Value Container Bundle Order
info Date Formula Etc.
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Challenges

• Multiple Equipment vendors Schedules
• Many Time dependencies
• Other systems may not be available for
  interfacing (i.e. different project timeline,
  go-live, etc)
• Data Synchronization in ERP, LIMS, WMS, MES,
  SCADA

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QUESTIONS ANSWERS