Related Tools, Guidance and Templates
- 21 CFR Part 11
- Scope of Guidance for Industry: Computerized Systems Used in Clinical Trials)
- Validation Plan Example template
- Functional Requirements Example template
- Design/Configuration Document Example template
- Installation Qualification Example template
- Operational/Performance Qualification Example template
- Final Validation Report Example template
- Change Control Preapproval
- Change Control Closure
- Inspections of Sponsors, CROs and Monitors
- Guidance for Industry Computerized Systems Used in Clinical Investigations
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
If you have any questions or concerns about your system, it is highly recommended that you contact the Office of Compliance Services or 310-794-6763 for assistance.