Validation of Computer Systems & Software

– A Practical Approach

Presented By Mr. Vasishtha MehtaDirectorEpitome Technologies Private Limited

Seminar on Validation Requirements for Regulatory ComplianceIndian Pharmaceutical Association

Date : 8th October,2011 Venue : Sci Tech Centre, Jogeshwari (W) - Mumbai

Topics Covered

Applicability of Computer System Validation GAMP Guide Lines & Good Practices ModelsGAMP V Model & Validation ProjectPractical Requirements

Applicability of Computer System Validation

Use of Automated Systems

4

Facilities & Facilities & Equipment Equipment SystemsSystems

Materials Materials SystemsSystems

Production Production SystemsSystems

Packaging & Packaging & Labeling Labeling SystemsSystems

Laboratory Laboratory SystemsSystems

Quality SystemsQuality Systems(Annual Product Review,(Annual Product Review, Customer Complaints, Training Records, Customer Complaints, Training Records,

CAPA, SOP Administration, Adverse Event Reporting)CAPA, SOP Administration, Adverse Event Reporting)

HVACHVACAutoclavesAutoclavesCalib & MaintCalib & MaintWFIWFI

Inv MgmtInv MgmtDispensaryDispensaryDist SystemsDist SystemsWH MgmtWH Mgmt

Process InstProcess InstControl SysControl SysEBREBRERPERP

Label GenLabel GenOCR SysOCR SysFill CheckFill CheckArtworkArtwork

Lab InstLab InstLIMSLIMSC of AC of AE-NotebooksE-Notebooks

Automating GMP Areas

Personnel Qualifications (211.25)Personnel Qualifications (211.25)

Consultants (211.34)Consultants (211.34)

Equipment Cleaning and Maint. (211.67)Equipment Cleaning and Maint. (211.67)

Automated Equipment (211.68)*Automated Equipment (211.68)*

Written Procedures (211.100)Written Procedures (211.100)

Materials Examination and Usage Materials Examination and Usage (211.122)(211.122)

Packaging and Labeling Oper. (211.130)Packaging and Labeling Oper. (211.130)

Drug Product Inspection (211.134)Drug Product Inspection (211.134)

Distribution Procedures (211.150)Distribution Procedures (211.150)

Reserve Samples (211.170)Reserve Samples (211.170)

Records and Reports (211.180)Records and Reports (211.180)

Equipment Cleaning and Use (211.182)Equipment Cleaning and Use (211.182)

Component, Container, Closure and Component, Container, Closure and Labeling Records (211.184)Labeling Records (211.184)

Master Production Records (211.186)Master Production Records (211.186)

Batch Production Records (211.188)Batch Production Records (211.188)

Production Record Review (211.192)Production Record Review (211.192)

Laboratory Records (211.194)Laboratory Records (211.194)

Distribution Records (211.196)Distribution Records (211.196)

Complaint Files (211.198)Complaint Files (211.198)

Returned Drug Products (211.204)Returned Drug Products (211.204)

Drug Product Salvaging (211.208)Drug Product Salvaging (211.208)

System Validation - Objectives Extensive Use of Software in GxP Environment

calls for Automated Systems’ Validation to ensure

System Functioning vis-à-vis its intended useInsurance against Data Manipulation Data Integrity on NetworksSystem Performance in Validated State

GAMP Guidelines & Good Practices Models

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Guidelines - GAMPGood Automated Manufacturing Practices (GAMP) provides the Framework for Automated System ValidationCurrent version GAMP 5 emphasizes Risk Based Approach to Software Validation with Life Cycle Model

GAMP Categories

CategoryCategory Software TypeSoftware Type CSV CriticalityCSV Criticality

11 Operating SystemOperating System LowLow

22 FirmwareFirmware Removed in GAMP 5Removed in GAMP 5

33 Standard Software Standard Software PackagesPackages

Medium - HighMedium - High

44 Configurable Software Configurable Software PackagesPackages

Medium - HighMedium - High

55 Custom or Bespoke Custom or Bespoke SystemsSystems

HighHigh

Current Good Practices Models

Process Control SystemsPLC / DCS / SCADA / BMS

Laboratory Computerized SystemsApplication Software Like HPLC /GC /FTIR etc

Global Information Systems ERP Systems Like SAP / BaaN Document Management Systems

GAMP V Model & Validation Project

GAMP V ModelGAMP V Model

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Validation Plan

Off the Shelf SOFTWARE

Off the Shelf SOFTWARE

SysAdmin Training

SysAdmin Training

Customer Installation & Configuration

Customer Installation & Configuration

OQ TestingOQ Testing

Validation Review

Validation Review

PQ TestingPQ Testing

IQ TestingIQ Testing

Trace Matrix

User TrainingUser Training

Supplier AuditRisk Management

Plan

Validation Planning Checklist

Go Live!Go Live!

Updated Risk Management

Plan

Final Validation

Report

Updated Risk Management

Plan

Configuration Drawing

HW /SW Requirements

Protocol Test Records

Protocol Test Records

Protocol Test Records

System Usage SOP’s

User Acceptance Criteria

Updated Risk Management

Plan

PQ Test Report

Training Records

Updated Risk Management

Plan

IQ / OQ Test Report

Sample Usage SOP’s

Training Records

Configuration Homework

User Requireme

nt Specificatio

n

Functional Requireme

nt Specificatio

n

Design Requireme

nt Specificatio

n

Risk Manageme

nt Plan

Trace Matrix

Installation Qualification Protocols

Final Validation

Report

Sample Usage SOPs

Validation Planning Checklist

Operational Qualification Protocols

Supplier Audit

Performance

Qualification Protocols

User Requirements Specification

Functional Requirements Specification

Design Requirements Specification

PQ Protocols

OQ Protocols

IQ Protocols

User Requireme

nt Specificatio

n

Functional Requireme

nt Specificatio

n

Design Requireme

nt Specificatio

n

Risk Manageme

nt Plan

Trace Matrix

Installation Qualification Protocols

Final Validation

Report

Sample Usage SOPs

Validation Planning Checklist

Operational Qualification Protocols

Supplier Audit

Performance

Qualification Protocols

Validation DocumentationCorrective / Preventative

Action

Custom Monitoring Program

System Maintenance

System Usage SOP’s

Practical Requirements

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Process Control Systems

Distributed Control SystemsProgrammable Logic ControllersSCADA / BMS

15

Process Control Systems

Access Control & Password ManagementProgram Back Up for PLC / HMI / SCADASet Parameter Ranges To Be Restricted / DefinedAlarm ManagementSystem Clock SynchronizationSystem Design Documents V/s Configuration CheckPrinters & ReportsElectronic Records & Signatures – Wherever ApplicableLife Cycle Management

16

Laboratory Computerized Systems

Instrument SoftwareHPLC, GC, FTIR etcStability Cambers, Incubators

Programmable instruments

Servere.g., for printing and archiving

Office computer

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Laboratory Computerized Systems

Access Control & Password ManagementAdequate User IdsData Back Up & RestoreData SecurityLaboratory Network & Server QualificationSystem Clock SynchronizationPrinters & RecordsElectronic Signatures & RecordsLife Cycle Management

18

Global Information Systems

Enterprise Resource Planning SystemsSAP, Other ERP Packages

Document Management Systems

19

Global Information Systems - ERPscGMP vs. System ConfigurationInterfacing of Quality Management System (BMRs) vs. ERP RecordsAccess Control & Password ManagementAdequate User IdsData Back Up & RestoreData SecurityNetwork & Server QualificationPaper Records vs. Electronic RecordsElectronic SignaturesLife Cycle Management

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Maintaining Control in OperationMaintaining Control in Operation (Post Validation) Program

should ensure the following –

All up-dates / new development / implementation are in line with the Change Control ProceduresRisk Assessment is carried out for all up-dates / new development / implementationValidation documents (SOPs / Protocols / Specifications) are reviewed and updated periodically Audit the Validation Status of various systemsMonitor the Performance of Systems Periodically

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Road Map To ComplianceFormulate Computer System Validation Policy – Top Line StatementForm the Core Team Formulate Validation Master PlanDefine IT policies & Procedures For New Systems Follow GAMP V Model – URS to PQFor Existing Systems

Take the inventory of SystemsCarry Out Impact AnalysisCarry Out Risk Assessment for each SystemClose the GapsUpdate the URS and follow GAMP v Model

Maintain Control in Operation

SummarySoftware System Validation is Critical for All Regulatory Functions including Research and ManufacturingScope of CSV covers All Software Systems in GxP Area Prevailing GAMP Guidelines Provide Framework for Designing CSV ProgramGAMP Advocates Life Cycle Approach and Risk Assessment to ascertain CSV ScopeCareful Planning of CSV reduces Duplicate Activities and CostIdentification of Electronic Records and Maintenance Thereof is Critical for All Software SystemsMaintaining Control in Operation is Essential Post Validation

Questions & Comments

Thank You For Your AttentionSincerely Yours