Last updated: August 17, 2026
Course Agenda
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 810
- 21 CFR Part 11
- Annex 11: Computerized 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
Overview of 21 CFR Part 11 (Part 11)
- 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 810 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
Scientific Case Review
Would you like to understand whether current clinical programs, recent research developments, or emerging approaches may be relevant to your individual situation?
Share your question with our scientific research team and receive information focused on the areas of current research that may be relevant to your case.
- Review of the information you provide
- Relevant research and clinical program information
- A clear response focused on your situation
What happens next?
Send your question, receive a focused scientific review, and get a clear response about research and clinical programs relevant to your situation.
Your scientific review will be prepared by Dr. Helen Melnik, PhD , who has more than 25 years of experience in stem cell research and international clinical programs.
No obligation. Your question will be reviewed confidentially.
Educational and research information only. This service does not constitute medical advice, diagnosis, prescription, or a personalized treatment recommendation.
