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The GAMP Guide
Validation of Automated Systems
Overview and Structure of
GAMP4
Sion Wyn
GAMP 4
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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
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GAMP4 Themes
• Defined Development Lifecycle
• Planning
• Risk and Impact Assessment
• User and Supplier Partnership
• Specifications
• Traceability
• Design Review
• Formal Testing and Verification
• Documented Evidence
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Defined Life Cycle
• Meeting the requirements for validation
• Ensuring fitness for purpose
• Integrated with validation concepts
• Following Good Software Engineering Practice
The Model
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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.
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Basic Framework for
Specification and Testing
System
Build
User
Requirements
Specification
Performance
Qualification
Functional
Specification
Operational
Qualification
Installation
Qualification
Design
Specification
VerifiesVerifies
VerifiesVerifies
VerifiesVerifies
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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!
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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
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Validation Planning
Formal, approved, plan defining:
• Strategy
• Deliverables
• Responsibilities
• Procedures and
Standards
Val Plan Val Report
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Validation Planning
Validation Strategy Based on:
• Risk Assessment
• Assessment and Categorization
of System Components
• Supplier Assessment VP VR
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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
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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
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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.
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User and Supplier Roles
• Success Requires
–Co-operation and partnership
–Clearly defined responsibilities
–Clearly defined requirements
–Clearly defined acceptance criteria
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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
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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
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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
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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
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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
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Verification
Verification by
– Testing
– Checking
– Reviewing
...that what is
specified has
been delivered
T
estin
g
T
estin
g
R
eview
R
eview
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Documented Evidence
• Documented evidence
to satisfy the
– User
– Internal auditor
– Regulator
• …that the delivered
system is fit for
purpose
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Principles and
Framework
Procedures and
Guidelines
Good Practice Guidance
Training and Education Materials
Structure of GAMP Guidance
GAMP4GAMP4
GuideGuide
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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
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• 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
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• 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
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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
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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
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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
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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
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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
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Training and Education
• Training materials from ISPE Seminars and training
courses
• Practical Training courses with workshop examples,
dealing with real world issues
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GAMP Body of Knowledge
GAMP Americas
PDA
Namur Group
APV
ISPE/GAMP
JETT
Supplier ForumSupplier Forum
GAMP Europe
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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
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Questions?
Sion Wyn
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