Validation of Computer Systems & Software – A Practical Approach Presented By Mr. Vasishtha Mehta Director Epitome Technologies Private Limited Seminar on Validation Requirements for Regulatory Compliance Indian Pharmaceutical Association Date : 8 th October,2011 Venue : Sci Tech Centre, Jogeshwari (W) - Mumbai
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Validation of Computer Systems & Software – A Practical Approach Presented By Mr. Vasishtha Mehta Director Epitome Technologies Private Limited Seminar.
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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
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
Access Control & Password ManagementAdequate User IdsData Back Up & RestoreData SecurityLaboratory Network & Server QualificationSystem Clock SynchronizationPrinters & RecordsElectronic Signatures & RecordsLife Cycle Management
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Global Information Systems
Enterprise Resource Planning SystemsSAP, Other ERP Packages
Document Management Systems
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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