Zuletzt aktualisiert: 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 Teil 211
- 21 CFR Teil 810
- 21 CFR Teil 11
- Annektieren 11: Computerized Systems
- Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
- Guidance: Allgemeine Grundsätze der Softwarevalidierung
- Guidance: Computergestützte Systeme für klinische Untersuchungen
- 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) Verfahren?
- 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
- Wie 21 CFR Teil 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 Teil 11 (Teil 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 Teil 58 GLP
- 21 CFR Teil 211 GMP
- 21 CFR Teil 312 GCP (IND)
- 21 CFR Teil 810 QSR
- Guidance: Teil 11 scope and application (September 2003)
- Guidance: Computergestützte Systeme für klinische Untersuchungen
- 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 Einhaltung
GAMP-Specific Computer Validation Topics
- The industry guidance for Good Automated Manufacturing Practice (SPORT)
- How GAMP addresses the FDA’s expectations for computer validation
- SPORT 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
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