Resources
- ISO
- FDA
- CDER
- CDRH
- CBER
- 21CFR Part11 FDA Guidance Document
- General Principles of Software Validation FDA Guidance Document
- Guidance for Industry: Computerized Systems Used in Clinical Investigations
- Society for Clinical Data Management
- Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance
- FDA Clinical Trials Guidance Documents
- GCP
- Medical Device Resource Group