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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
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
8
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
12
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
14
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
17
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
20
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
21
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