as of 2019 - 12 - 10
9 Computer System Validation
9.A Introduction and terminology
Summary
9.B Legal aspects
Summary:
9.B.1 Europe
9.B.2 USA
9.B.3 PIC/S
9.B.4 Electronic signatures and electronic records
9.B.5 ISPE GAMP® 5 – Good Automated Manufacturing Practice
9.C System life cycle
Summary:
9.C.1 The “V model”
9.C.2 Software development
9.C.3 Configuration and customisation
9.D System classification and risk management
Summary
9.D.1 System classification according to ISPE GAMP®5
9.D.1.1 Category 1: IT Infrastructure
9.D.1.2 Category 2: Firmware
9.D.1.3 Category 3: Non-configured software
9.D.1.4 Category 4: Configured software
9.D.1.5 Category 5: Customer-specific software
9.D.1.6 Validation tasks depending on system categories
9.D.2 Risk management
9.D.2.1 Using the FMEA method
9.D.2.2 Risk reduction/mitigation
9.E Validation of computerised systems
Summary:
9.E.1 Validation organisation
9.E.1.1 Responsibilities
9.E.1.2 Validation policy
9.E.1.3 Inventory of systems
9.E.1.4 Documentation structure
9.E.2 Validation plan
9.E.3 Specifications (user requirements/technical specification)
9.E.4 Unit, integration, system and acceptance tests
9.E.4.1 Test phases
9.E.4.2 Test methods
9.E.5 Validation report
9.E.6 Data migration and start-up
9.E.7 Examples
9.E.7.1 Enterprise Resource Planning (ERP) systems
9.E.7.2 Electronic Batch Recording (EBR)
9.E.7.3 Document Management Systems (DMSs)
9.E.7.4 PLC systems
9.E.7.5 Qualifying the IT infrastructure
9.E.7.6 Spreadsheet
9.E.7.7 Laboratory systems
9.E.8 Retrospective validation
9.E.8.1 Analysis of the actual status
9.E.8.2 Experience report
9.F Operation of computerised systems
Summary
9.F.1 System description
9.F.2 User training
9.F.3 Standard operating procedures (SOPs)
9.F.4 Access and security
9.F.4.1 Authorised access
9.F.4.2 Security
9.F.5 Data backup and archiving
9.F.5.1 Data backup
9.F.5.2 Archiving
9.F.6 Contingency plans
9.F.7 Change management and error reporting
9.F.7.1 Changes
9.F.7.2 Error reporting
9.F.8 Periodic review
9.F.9 Retirement of computerised systems
9.G External service providers
Summary:
9.G.1 Relocation of activities
9.G.2 Service level agreement
9.G.2.1 Contents of a service level agreement
9.G.2.2 Example of a service level agreement
9.G.3 Auditing of suppliers and service providers
9.H Validation of Excel applications
Summary:
9.H.1 Introduction
9.H.2 Risks
9.H.2.1 Application risks
9.H.2.2 Technology-related risks
9.H.2.3 Development-related risks
9.H.2.4 Environment-related risks
9.H.2.5 User-related risks
9.H.2.6 Compliance and inspection risks
9.H.3 Regulations
9.H.3.1 Overview of the relevant regulations
9.H.3.2 Spreadsheet requirements in Annex 11
9.H.4 Risk management for spreadsheets
9.H.4.1 Specific elements of risk management
9.H.4.2 Classification of Excel applications
9.H.4.3 Definition of the types of Excel applications
9.H.5 Process models for the validation of Excel applications
9.H.5.1 General scalable approach (adjustable standard catalogue)
9.H.5.2 Process model for type 1: Text input
9.H.5.3 Process model for type 2: Pocket calculator replacement
9.H.5.4 Process models for type 3: Template-based calculation systems
9.H.5.5 Process model for type 4: Excel lists
9.H.5.6 Process model for type 5: Complex data evaluation
9.H.5.7 Process model for type 6: Excel-based data systems
9.H.6 Process and documentation
9.H.6.1 Validation documentation
9.H.6.2 Procedural elements
9.H.6.3 System documentation
9.H.6.4 Reviews
9.H.6.5 Tests
9.H.7 Operational concept for GMP-compliant Excel applications
9.I References
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