GAMP4 Overview

1 The GAMP Guide Validation of Automated Systems Overview and Structure of GAMP4 Sion Wyn GAMP 4 2 Why Are Guidelines Necessary? 8 To interpret the regulations 8 To clarify the requirements 8To help communication 8 To manage the costs 8 To achieve compliance 3 GAMP4 Themes • Defined Development Lifecycle • Planning • Risk and Impact Assessment • User and Supplier Partnership • Specifications • Traceability • Design Review • Formal Testing and Verification • Documented Evidence 4 Defined Life Cycle • Meeting the requirements for validation • Ensuring fitness for purpose • Integrated with validation concepts • Following Good Software Engineering Practice The Model 5 General Validation Activities Planning Specification Testing IQ, OQ, PQ Review Test Planning IQ, OQ, PQ Prepare written Validation Plan. Specify and agree what is required. Perform Design Reviews Prepare document to describe how the equipment or system is to be tested. Perform tests and collect results. Review results to show that the system performs as specified, report conclusions plus any reservations. 6 Basic Framework for Specification and Testing System Build User Requirements Specification Performance Qualification Functional Specification Operational Qualification Installation Qualification Design Specification VerifiesVerifies VerifiesVerifies VerifiesVerifies 7 Development Life Cycle 8 Planning and Specification 8 Design 8 Construction 8 Testing 8 Installation 8 Acceptance Testing 8 Operation Now Includes Now Includes Package Configuration!Package Configuration! New!New! 8 Mapping of Validation Activities to the Development Life Cycle Figure 3: OPERATION PLANNING AND SPECIFICATION DESIGN CONSTRUCTION TESTING INSTALLATION ACCEPTANCE TESTING VALIDATION PLAN SUPPLIER ASSESSMENTS CONSTRUCTION AND CODE REVIEWS MONITOR SUPPLIER INSTALLATION QUALIFICATION OPERATIONAL QUALIFICATION PERFORMANCE QUALIFICATION VALIDATION REPORT ONGOING OPERATION DESIGN REVIEWS 9 Validation Planning Formal, approved, plan defining: • Strategy • Deliverables • Responsibilities • Procedures and Standards Val Plan Val Report 10 Validation Planning Validation Strategy Based on: • Risk Assessment • Assessment and Categorization of System Components • Supplier Assessment VP VR 11 Risk and Impact Assessment • Identify processes • Assess risk and document • Analyse: – Risk scenarios – Effects for each event – Likelihood of events – Severity of impact – Likelihood of detection • Plan for risk management RiskRisk EffortEffort 12 Risk and Impact Assessment • Mitigation strategies discussed – Modification of process or design: Avoidance, process design, system design, external process – Project strategy: Project structure, auditable ”built-in quality” – Validation and test strategy: RiskRisk EffortEffort 13 User and Supplier Roles • Guidance to help users understand the requirements for prospective validation of an automated system and the level to which the validation should be performed. • Guidance to help suppliers ensure that systems are developed according to good practice, and to provide documentary evidence that their systems meet the agreed specifications. 14 User and Supplier Roles • Success Requires –Co-operation and partnership –Clearly defined responsibilities –Clearly defined requirements –Clearly defined acceptance criteria 15 Sections in GAMP4 include: • Overview of User Activities • Management System for Suppliers of IT Systems – Including Laboratory Systems • Validation of Process Control Systems – Including Laboratory Equipment User and Supplier Roles 16 Specifications For communication between users, suppliers, and regulators: • Define the System • Allow further specifications to be developed • Allow the system to be developed • Allow maintenance of the system GAMP4 includes Package Configuration Specifications and Test Specifications 17 User-Supplier Relationship Software Design Specification Software Design Specification Code ModulesCode Modules Config. SpecificationConfig. Specification System Acceptance TestingSystem Acceptance Testing Hardware Acceptance Testing Hardware Acceptance Testing Software Integration Testing Software Integration Testing Config. TestingConfig. Testing Review and Test Modules Review and Test Modules Primary Responsibility for Testing User Requirements Specification Functional Specification Hardware Design Specification Primary Responsibility for Specification User User Supplier Testing of the URS Testing of the Functional Specification Testing of the Hardware Specification Supplier Software Module Specification Software Module Specification Software Module Testing Software Module Testing M or e M or e u se r u se r in vo lv em en t f or c us to m in vo lv em en t f or c us to m sy st em s, le ss fo r pa ck ag ed sy st em s, le ss fo r pa ck ag ed M or e M or e su p p lie r su p p lie r in vo lv em en t f or in vo lv em en t f or cu st om s ys te m s, le ss fo r p ac ka ge d cu st om s ys te m s, le ss fo r p ac ka ge d 18 Traceability Ensuring that: · All requirements are met and can be traced to the appropriate design elements · All requirements are verified, and can be traced to test or verification activity that shows that that requirement has been met 19 Design Review • Evaluate deliverables against standards and requirements • Identify problems, and propose required corrective actions. • Planned and systematic reviews of specifications, design, and development • Occur at suitable stages during the life cycle 20 Verification Verification by – Testing – Checking – Reviewing ...that what is specified has been delivered T estin g T estin g R eview R eview 21 Documented Evidence • Documented evidence to satisfy the – User – Internal auditor – Regulator • …that the delivered system is fit for purpose 22 Principles and Framework Procedures and Guidelines Good Practice Guidance Training and Education Materials Structure of GAMP Guidance GAMP4GAMP4 GuideGuide 23 Principles and Framework • A strategic framework for computer validation drawing together the key validation principles and practices • How to apply these principles to determine extent and scope of validation for different types of systems 24 • Introduction to GAMP – Including Purpose, Scope, and Benefits • Validation Overview • Validation Life Cycle – Including User Requirements Specification, Determining Validation Strategy, Validation Reporting, and Maintaining the Validated State • Management System for IT • Process Control System Validation • Benefits of Validation • Good Practice Definitions • Glossary, Acronyms, and Source Material Principles and Framework GAMP 4 25 • A supporting set of rationalized and revised procedures and guidelines that support computer systems validation and compliant operation. – Project management & control procedures – Project development procedures – Operational procedures • Management • Development • Operation Procedures and Guidelines 26 Management • Validation Planning • Supplier Audit • Risk Assessment • Categories of software and hardware • Design Review and Traceability Matrix • Quality and Project Planning • Document Mangement • Project Change Control • Configuration Management • Validation Reporting 27 Development • User Requirement Specification • Functional Specification • Hardware Design Specification • Software Design and Software Module Design Specification • Production, Control, and Review of Software • Testing of an Automated System 28 Operation • Periodic Review • Service Level Agreement • Automated System Security • Operational Change Control • Performance Monitoring • Record Retention, Archive and Retrieval • Backup and Recovery of Software and Data • Business Continuity Planning • EU Annex 11 – APV Interpretation 29 Good Practice Guidance (To be Published Separately) • Practical guidance covering good practice case studies and other GAMP publications • Extend current Volume 2 of GAMP 3 30 Good Practice Guidance (Topics in progress or under consideration) • Legacy Systems • Infrastructure • Process Systems and “Skid Mounted” Equipment • Calibration Management • Electronic Records and Signatures – Part of joint ISPE/PDA series • Global IT Systems 31 Training and Education • Training materials from ISPE Seminars and training courses • Practical Training courses with workshop examples, dealing with real world issues 32 GAMP Body of Knowledge GAMP Americas PDA Namur Group APV ISPE/GAMP JETT Supplier ForumSupplier Forum GAMP Europe 33 Benefits of GAMP 4 • Reduced cost of validation • Reduced time for validation • Framework for international acceptance & harmonization of approach • Improved understanding of the subject matter • Elimination of retrospective validation as a strategy • Common language, and clear responsibilities • Understanding of benefits of validation 34 Questions? Sion Wyn