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Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11) Course & Certification
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Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
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About
The Computer System Validation – Validation, Data Integrity & Compliance (GAMP 5 & Annex 11) Course & Certification is designed to provide a comprehensive understanding of validating computerized systems used in pharmaceutical, biotechnology, and life sciences environments. The course focuses on ensuring systems are fit for intended use, compliant with regulatory expectations, and capable of maintaining data integrity throughout the system lifecycle.
This course covers CSV lifecycle, risk-based approach, data integrity (ALCOA+), EU Annex 11 requirements, vendor management, change control, testing strategies, and audit readiness. It also emphasizes documentation practices, cloud system compliance, and real-world case studies in CSV implementation and compliance. Upon successful completion, learners receive a certification demonstrating competency in CSV, GAMP 5, and Annex 11 compliance.
Who Should Enrol?
- Validation and CSV Professionals
- Quality Assurance and Quality Control Teams
- IT and Computer System Support Teams in Pharma
- Regulatory Affairs and Compliance Professionals
- Manufacturing and Engineering Professionals
- Clinical Data Management and Clinical Operations Teams
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Chemistry, IT, and Engineering Graduates
What you will learn
Understand the fundamentals of Computer System Validation (CSV) in GxP environments, including regulatory expectations under GAMP 5 and Annex 11.
Learn the risk-based validation approach across the system lifecycle, including requirements, design, testing, qualification, and release.
Gain knowledge of key compliance areas such as data integrity (ALCOA+), supplier and cloud system management, and change control processes.
Develop an understanding of audit readiness, ongoing system maintenance, and real-world case studies and failures in computerized system validation and compliance.
Course Syllabus
- Introduction to GxP Computerised Systems
- What You Will Learn in This Course
- Computer System Validation — An Introduction
- What Are GxP Computerised Systems?
- Common GxP Systems
- Why CSV and Compliance Matter
- The GxP Family of Practices
- Risks of Poor Computerised Systems Management
- Stakeholders in CSV
- Data Integrity at the Heart
- The Validation Lifecycle
- Risk-Based Approach
- Validation vs. Qualification
- GAMP 5 Software Categories
- FDA's Computer Software Assurance (CSA)
- 21 CFR Part 11 in Brief
- EU GMP Annex 11 in Brief
- Regulatory Framework
- The Regulatory Landscape
- Why This Matters
- 21 CFR Part 11 Overview
- Part 11 Subpart A General Provisions
- Part 11 Subpart B Electronic Records
- Part 11 Subpart C Electronic Signatures
- FDA Scope and Application Guidance (2003)
- EU GMP Annex 11 Overview
- Annex 11 Section 1 Risk Management
- Annex 11 Section 2 Personnel
- Annex 11 Section 3 Suppliers and Service Providers
- Annex 11 Section 4 Validation
- Annex 11 Sections 5-8 - Operations
- Annex 11 Sections 9-11 - Audit Trails and Change
- Annex 11 Sections 12-17 - Security and Continuity
- GAMP 5 and Risk-Based Approach
- Introduction to GAMP 5 Guidelines for CSV
- What Is GAMP 5?
- Core Principles of GAMP 5
- Why GAMP 5 Matters
- GAMP 5 Lifecycle Phases
- GAMP 5 Software Categories
- GAMP 5 Software Categories — Classification Framework
- Category 1 Infrastructure
- Category 3 Non-configured Products
- Category 4 Configured Products
- Category 5 Custom Applications
- GAMP 5 Risk Process Step 1 Initial Risk Assessment
- GAMP 5 Risk Process Step 2 Functional Risk Assessment
- GAMP 5 Risk Process Step 3 Risk Control
- GAMP 5 Risk Process Step 4 Risk Review
- Leveraging Supplier Involvement
- Critical Thinking in CSV
- FDA's CSA Alignment with GAMP 5
- Computerised System Lifecycle
- Why Lifecycle Thinking Matters
- The Four Lifecycle Phases
- Concept Phase Activities
- System Lifecycle with Quality Gates
- Phase 1 of CSV — The Concept Phase
- Phase 2 of CSV — The Project Phase
- Phase 3 of CSV — The Operation Phase
- Phase 4 of CSV — The Retirement Phase
- Multi-Phase Overview & CSV Checklist
- Concept Phase Deliverables
- Project Phase Overview
- User Requirements Specification (URS)
- Functional Specification (FS)
- Design Specification (DS)
- Traceability Matrix
- Configuration Management
- Build and Code Review
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Report
- Operation Phase Activities
- Periodic Review
- Change Control in Operation
- Incident and Problem Management
- Retirement Phase Overview
- Data Migration
- Data Archiving
- Validation: CSV and CSA Approaches
- What Validation Means in CSV
- CSV: Computer System Validation
- CSA: Computer Software Assurance
- CSV vs. CSA: Key Differences
- When to Use CSA Approaches
- When CSV-Heavy Is Still Right
- The Validation Process in CSV
- Validation Master Plan (VMP)
- Validation Plan (VP)
- Risk-Based Test Strategy
- Test Types in CSV
- Test Script Design
- Test Execution
- Defect Management
- Exploratory and Unscripted Testing
- Automated Testing
- Test Environments
- Validation Documentation Hierarchy
- User Requirements and System Design
- Why Requirements Matter
- Anatomy of a Good Requirement
- Categories of Requirements
- User Requirements Specification (URS)
- V-Model: Requirements to Qualification
- URS Structure
- Eliciting Requirements
- Requirements Prioritisation
- Functional Specification (FS)
- Design Specification (DS)
- Configuration Specification
- Traceability Matrix
- Design Reviews
- Regulatory Requirements in URS
- Security and Access Control Requirements
- Audit Trail Requirements
- Electronic Signature Requirements
- Data Lifecycle Requirements
- Integration Requirements
- Performance Requirements
- Testing, Qualification and Release
- Why Testing Matters
- The Testing Hierarchy
- IQ / OQ / PQ Qualification Flow
- Installation Qualification (IQ)
- IQ Protocol Structure
- Operational Qualification (OQ)
- OQ Test Types
- Performance Qualification (PQ)
- Test Script Design
- Test Data Management
- Test Environment Management
- Test Execution Discipline
- Defect Logging and Tracking
- Defect Severity Classification
- Test Reports
- Release Decision
- User Acceptance Testing (UAT)
- Performance and Load Testing
- Security Testing
- Audit Trail Testing
- Integration Testing
- Regression Testing
- Data Integrity (ALCOA+)
- What Is Data Integrity?
- Why Data Integrity Matters
- ALCOA Principles
- ALCOA+ Data Integrity Principles
- Data Integrity in CSV — ALCOA+ Principles
- ALCOA+ Extensions
- Attributable in Detail
- Legible in Detail
- Contemporaneous in Detail
- Original in Detail
- Accurate in Detail
- Data Lifecycle
- Audit Trails The Heart of Data Integrity
- Audit Trail Configuration
- Audit Trail Review
- Access Controls and Data Integrity
- Electronic Signatures
- Hybrid Systems
- Data Integrity Risks
- More Data Integrity Risks
- MHRA GxP Data Integrity Guidance
- FDA Data Integrity Guidance
- PIC/S PI 041 Data Integrity Guidance
- Supplier Management and Cloud Systems
- Why Supplier Management Matters
- Types of Suppliers
- Annex 11 Section 3 Requirements
- Quality Agreements
- Cloud Shared Responsibility Model
- Supplier Qualification
- Risk-Based Supplier Audits
- Cloud Computing in GxP
- Shared Responsibility Model
- SaaS-Specific Considerations
- Cloud Validation Approach
- Data Residency and Privacy
- Cloud Security Considerations
- Supplier Change Notifications
- Vendor Update Cycles
- Change Control and System Maintenance
- Why Change Control Matters
- Categories of Change
- Change Control Process
- Risk Assessment of Changes
- Like-for-Like Changes
- Emergency Changes
- Patches and Updates
- Configuration Changes
- Software Upgrades
- Periodic Review
- Periodic Review Scope
- System Performance Monitoring
- Backup and Recovery
- Business Continuity
- Incident Management
- Audit and Inspection Readiness
- Why Audit Readiness Matters
- Types of Audits and Inspections
- Self-Inspection Programme
- Inspection Findings Severity
- Audit Planning
- Audit Scope for CSV
- Pre-Audit Preparation
- Inspection Day Behaviour
- Documents Inspectors Request
- Inspection Response Workflow
- More Documents Inspectors Request
- Common Inspector Questions
- Findings Classification
- Responding to Findings
- FDA Form 483
- FDA Warning Letter
- EU GMP Inspection Outcomes
- Case Studies and Real Failures
- Why Case Studies Matter
- Sources of Industry Learning
- Patterns in Data Integrity Cases
- What Mature Organisations Do Differently
- Building a Learning Organisation
- Cultural Indicators of Maturity
- Cultural Warning Signs
- How to Use Case Studies Internally
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, FDA CSA guidance, ICH Q9/Q10, and PIC/S PI 011/041 as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by industry practitioners and subject-matter experts to ensure that learners can apply the principles directly in their daily work. Every module follows a consistent rhythm — concept, regulatory context, real-world failure, audit perspective, preventive controls, and a knowledge check.
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