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life cycle
GxP
vald life cycle
The Validation Life Cycle refers to the systematic process used to ensure that a system, product, or process consistently meets predefined requirements and performs as intended. It is especially important in regulated industries like pharmaceuticals, biotechnology, and medical devices, but it's also used in software development and manufacturing.
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2 Enrolled
1 Lessons
  1. Planning Phase
  2. Objective: Define the scope, responsibilities, and approach.
  3. Key Document: Validation Master Plan (VMP)
  4. Includes:
  5. Risk assessments
  6. Resource planning
  7. Regulatory requirements
  8. Design Qualification (DQ)
  9. Objective: Ensure that the design meets all user and regulatory requirements.
  10. Applies To: Facilities, equipment, software, systems
  11. Outputs: Documented evidence that design specifications are suitable.
  12. Installation Qualification (IQ)
  13. Objective: Verify that equipment or systems are installed correctly and according to the manufacturer’s specifications.
  14. Includes:
  15. Component checks
  16. Installation procedures
  17. Documentation verification
  18. Operational Qualification (OQ)
  19. Objective: Test and verify that the system or equipment performs within defined operating ranges.
  20. Includes:
  21. Test protocols for functionality
  22. Calibration
  23. Alarms and error handling
  24. Performance Qualification (PQ)
  25. Objective: Ensure the system performs as expected under real-world conditions.
  26. Includes:
  27. Simulated or live operation
  28. Reproducibility checks
  29. Stress testing
  30. Validation Report
  31. Objective: Summarize findings and confirm that all validation steps were successfully completed.
  32. Includes:
  33. Results
  34. Deviations and resolutions
  35. Final approval for use
  36. Change Control & Revalidation
  37. Objective: Ensure that any changes to the system/equipment/process are evaluated and, if needed, revalidated.
  38. Ongoing: Throughout the lifecycle
  39. Periodic Review
  40. Objective: Confirm that the system remains in a validated state over time.
  41. Includes:
  42. Review of deviations
  43. CAPA (Corrective and Preventive Actions)
  44. Audit trails


Course Content
Phases of the Validation Life Cycle Planning Phase Objective: Define the scope, responsibilities, and approach. Key Document: Validation Master Plan (VMP) Includes: Risk assessments Resource planning Regulatory requirements Design Qualification (DQ) Objective: Ensure that the design meets all user and regulatory requirements. Applies To: Facilities, equipment, software, systems Outputs: Documented evidence that design specifications are suitable. Installation Qualification (IQ) Objective: Verify that equipment or systems are installed correctly and according to the manufacturer’s specifications. Includes: Component checks Installation procedures Documentation verification Operational Qualification (OQ) Objective: Test and verify that the system or equipment performs within defined operating ranges. Includes: Test protocols for functionality Calibration Alarms and error handling Performance Qualification (PQ) Objective: Ensure the system performs as expected under real-world conditions. Includes: Simulated or live operation Reproducibility checks Stress testing Validation Report Objective: Summarize findings and confirm that all validation steps were successfully completed. Includes: Results Deviations and resolutions Final approval for use Change Control & Revalidation Objective: Ensure that any changes to the system/equipment/process are evaluated and, if needed, revalidated. Ongoing: Throughout the lifecycle Periodic Review Objective: Confirm that the system remains in a validated state over time. Includes: Review of deviations CAPA (Corrective and Preventive Actions) Audit trails
vald life cycle - Training and Assessment