Computer System Validation

Program Overview

This program provides an end-to-end mastery of the CSV (GAMP5, CSA, 21 CFR Part 11, Annex 11 and Annex 22, GPSV). It transitions participants from theoretical understanding to practical, risk-based execution in a GxP regulated environment.

Target Audience:

• Entry-Level: Individuals new to CSV/Validation. (Any Degree)
• IT Professionals: Systems admins and developers in life sciences.
• Quality & Compliance: QA/QC professionals overseeing digital systems.
• Engineers: Automation and process engineers.
• Lead Validators: Experienced practitioners shifting to modern, risk-based approaches.

Phase 1: Foundations & Core Philosophy (Modules 1-8)

Goal: Understand the “Why” and the “Mindset” behind GAMP 5.

• Module 01: Why GAMP Exists: Shift to risk-based approach, focus on patient safety, and GAMP as guidance not regulation.
• Module 02: History & Evolution: Progression from GAMP 1 to GAMP 5 (2nd Edition), drivers for change, and balancing innovation with compliance.
• Module 03: New Topics in 2nd Edition: Cloud/SaaS, Agile and iterative development, AI/ML, and emphasis on critical thinking.
• Module 04: Scope of Guidance: Application in GxP environments, system types, and role of software suppliers.
• Module 05: Five Key GAMP Concepts: Product understanding, lifecycle approach, scalability, science-based risk, and leveraging suppliers.
• Module 06: Regulations/Guidelines: 21 CFR Part 11, Annex 11 and GAMP5 2^nd Edition
• Module 07: Validation Framework: Fitness for intended use, validation planning, and operational controls.

Module 08: Critical Thinking: Moving beyond checkbox compliance and scaling documentation based on risk.

Phase 2: The System Lifecycle Model (Modules 9-13)

Goal: Mastering the four phases of the system journey.

• Module 09: Lifecycle Overview/SDLC: The macro view—Concept, Project, Operation, and Retirement. Waterfall, V- Model, Agile methodology
• Module 10: Concept Phase: Identifying business needs, initial GxP assessments, and “Go/No-Go” decisions.
• Module 11: Project Phase: Planning, Specification, Configuration, Verification, and Release.
• Module 12: Operation Phase: Maintaining the “Validated State” through change control and monitoring.
• Module 13: System Retirement: Data retention, migration strategies, and controlled decommissioning.

Phase 3: Risk Management & Governance (Modules 14-19)

Goal: Science-based decision making and organizational accountability.

• Module 14: Risk Management Principles: Impact on Patient Safety, Product Quality, and Data Integrity (SQuID) and FMEA, CSA.
• Module 15: The Risk Process: Step-by-step Identification, Assessment, Control, and Review.
• Module 16: Governance: Organizational frameworks, policies, and management’s role in compliance.
• Module 17: System-Specific Activities: Defining ownership and evidence generation across the lifecycle.
• Module 18: Supplier Role: Why the regulated company must leverage supplier activities to be efficient.
• Module 19: Supplier Quality: Conducting assessments and integrating supplier deliverables into the validation package.

Phase 4: Project Execution & Deliverables (Modules 20-29)

Goal: Practical documentation and technical execution.

• Module 20: Validation Planning (The Roadmap).
• Module 21: Requirements Specification (URS/FS).
• Module 22: System Design & Configuration (The “How”).
• Module 23: Verification & Testing (IQ/OQ/PQ or integrated testing), STLC
• Module 24: Traceability (Linking requirements to testing).
• Module 25: Validation Reporting (The Summary).
• Module 26: Change & Configuration Management.
• Module 27: Documentation Management (ALCOA+ principles).
• Module 28: Data Migration (Strategies for moving legacy data).
• Module 29: Handover to Operation (Transitioning from Project to BAU).

Phase 5: Operational Excellence & Modern Tech (Modules 30-42)

Goal: Sustaining compliance and adapting to new technologies.

• Operational Control:
  • Module 30: Incident & Problem Management.
  • Module 31: Periodic Review (Is the system still compliant?), GAP Assessment
  • Module 32: Security Management.
  • Module 33: Backup & Business Continuity, Archiving & Retrieval.
  • Module 34: Quality Management System. (Change management, Deviation, Incident)
• Efficiency & Modernity:
  • Module 35: Leveraging Supplier Documentation (Reducing rework).
  • Module 36: Efficient Testing Practices (Unscripted vs. Scripted).
  • Module 37: Agile & Iterative Approaches in GxP.
  • Module 38: Automation & Validation Tools.(Veeva)
  • Module 39: Data Integrity (ALCOA ++)
• Advanced Topics:
  • Module 40: Cloud & Service Providers (SaaS/PaaS/IaaS).
  • Module 41: AI/ML Systems (Validating the “Black Box”).

Phase 6: Final Capstone (Module 42)

Goal: Practical application.

• Module 42: End-to-End Validation Project Simulation:
  • A simulated case study from initial concept through to retirement.
  • Practice in risk assessment and critical thinking.