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

Applicability of Computer System Validation

Use of Automated Systems *Facilities & Equipment SystemsMaterials SystemsProduction SystemsPackaging & Labeling SystemsLaboratory SystemsQuality Systems(Annual Product Review, Customer Complaints, Training Records, CAPA, SOP Administration, Adverse Event Reporting)HVACAutoclavesCalib & MaintWFIInv MgmtDispensaryDist SystemsWH MgmtProcess InstControl SysEBRERPLabel GenOCR SysFill CheckArtworkLab InstLIMSC of AE-Notebooks

Automating GMP Areas Personnel Qualifications (211.25)Consultants (211.34)Equipment Cleaning and Maint. (211.67)Automated Equipment (211.68)*Written Procedures (211.100)Materials Examination and Usage (211.122)Packaging and Labeling Oper. (211.130)Drug Product Inspection (211.134)Distribution Procedures (211.150)Reserve Samples (211.170)Records and Reports (211.180)Equipment Cleaning and Use (211.182)Component, Container, Closure and Labeling Records (211.184)Master Production Records (211.186)Batch Production Records (211.188)Production Record Review (211.192)Laboratory Records (211.194)Distribution Records (211.196)Complaint Files (211.198)Returned Drug Products (211.204)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--vis its intended useInsurance against Data Manipulation Data Integrity on NetworksSystem Performance in Validated State

GAMP Guidelines & Good Practices Models

*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

CategorySoftware TypeCSV Criticality1Operating SystemLow2FirmwareRemoved in GAMP 53Standard Software PackagesMedium - High4Configurable Software PackagesMedium - High5Custom or Bespoke SystemsHigh

Current Good Practices ModelsProcess Control SystemsPLC / DCS / SCADA / BMSLaboratory Computerized SystemsApplication Software Like HPLC /GC /FTIR etcGlobal Information Systems ERP Systems Like SAP / BaaN Document Management Systems

GAMP V Model & Validation Project

GAMP V Model*Validation PlanOff the Shelf SOFTWARE SysAdmin TrainingCustomer Installation & ConfigurationOQ TestingValidation ReviewPQ TestingIQ Testing Trace MatrixUser TrainingSupplier AuditRisk Management PlanValidation Planning ChecklistGo Live!Updated Risk Management PlanFinal Validation ReportHW /SW RequirementsProtocol Test RecordsProtocol Test RecordsProtocol Test RecordsTraining RecordsSample Usage SOPsUser Requirements Specification

Functional Requirements Specification

Design Requirements Specification

User Requirement SpecificationFunctional Requirement SpecificationDesign Requirement SpecificationRisk Management PlanTrace MatrixInstallation Qualification ProtocolsFinal Validation ReportSample Usage SOPsValidation Planning ChecklistOperational Qualification ProtocolsSupplier AuditPerformance Qualification ProtocolsValidation Documentation

Practical Requirements

*Process Control SystemsDistributed Control SystemsProgrammable Logic ControllersSCADA / BMS

*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

*Laboratory Computerized Systems

Instrument SoftwareHPLC, GC, FTIR etcStability Cambers, Incubators

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

*Global Information SystemsEnterprise Resource Planning SystemsSAP, Other ERP PackagesDocument Management Systems

*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

*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

*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 ModelMaintain 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 Attention Sincerely Yours

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