Computer Validation – General Overview

• Computer Validation fundamentals – a walk-through of a complete validation of a small example system
• Who needs to validate?
• What is Computer Validation?
  • Core principles
  • Brief history of computer validation
• Why is validation necessary and what regulations guide validation requirements?
• Review of the computer validation references in regulations and guidances:
  • 21 CFR Part 211
  • 21 CFR Part 820
  • 21 CFR Part 11
  • Annex 11: Computerised Systems
  • Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
  • Guidance: General Principles of Software Validation
  • Guidance: Computerized Systems Used in Clinical Investigations
• When and how are systems validated?
• Review of key FDA Warning Letters related to computer validation

Computer Validation Process and Deliverables

• What is the SDLC (System Development Life Cycle) process?
• How does computer validation fit into the SDLC?
• What content must be covered?
• What are the expected tasks and deliverables?
• System/software specifications
• Requirements options and documentation
• How 21 CFR Part 11 applies to computer validation
• Design Qualification (DQ) and vendor selection
• Risk Assessment in computer validation
  • Where does it apply?
  • A walkthrough of the GAMP risk assessment process
• Validation Plans and Master Validation Plans
• Installation Qualification (IQ)
  • ­The five topics expected in IQ documents
• Operational Qualification (OQ) and Performance Qualification (PQ)
  • ­Testing strategies and level of detail
  • How much testing is enough?
  • Examples of effective test cases and system errors discovered
• SOPs required for system operation and maintenance
  • ­How they related to FDA Warning Letters
• Validation Summary Reportse

Day 1 wrap-up

• General questions and answers 

• Background and purpose of Part 11
• Overview of Part 11 (review regulation)
• Review of the Part 11 implications in regulations and guidances:
  • 21 CFR Part 58   GLP
  • ­21 CFR Part 211 GMP
  • ­21 CFR Part 312 GCP (IND)
  • 21 CFR Part 820 QSR
  • Guidance:  Part 11 scope and application (September 2003)
  • Guidance: Computerized Systems Used in Clinical Investigations
  • Guide to the Inspection of Pharmaceutical Laboratories
• Review of Part 11-related FDA Warning Letters
• Discussion of example systems and the evaluation of Part 11 Compliance decisions
• Industry trends and approaches – the future of Part 11 issues
• Interactive discussion of Part 11 issues and concerns (bring your questions)
• Achieving and Maintaining Part 11 Compliance

GAMP-Specific Computer Validation Topics

• The industry guidance for Good Automated Manufacturing Practice (GAMP)
• How GAMP addresses the FDA’s expectations for computer validation
• GAMP 5 versus GAMP 4
• How to transition to GAMP 5 from GAMP 4
• A review of the supplementary GAMP guidances and where they apply

Auditing Computer Systems

• Auditing GxP computer systems
• Auditing suppliers of computer systems for GxP use
• Auditing developers for customized systems
• The general process for auditing computer systems
• Variations that can save time and money
• Review of an example audit checklist
• Primary areas of focus (what to look for)
• Examples of audit findings

Day 2 wrap-up

• Interactive Discussion / Question and Answer Period
• Additional CSV topics (TBD during course by attendees, “Parking Lot”)
• General questions and answer

Bonus Materials on CD ROM

• Indexed, searchable  FDA Warning Letters related to computer validation and Part 11 (PDF)
• Reference documents used in the course (PDF)
• Generic templates for computer validation documents, including Validation Plan, URS, FS, IQ, OQ, PQ, SOP Checklist, and Summary Report (MSWORD)

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