As an application intended for the storage and management of source documents related to FDA regulated clinical trials, SourceDrive has been expressly designed as a 21 CFR Part 11 compliant platform. The software design has been reviewed by an independent auditor (StratusG Consulting, March 2017) to verify compliance (contact us for more information). Design considerations related to compliance:
- Strong authentication requirements including Two-Factor authentication.
- Role Based Access Controls
- Audit Log for Resource Creation, Modification, and Deletion
- Documents and Data Retained Indefinitely
- Compliant Electronic Signatures
Each organization that uses SourceDrive is responsible for validating that its specific use cases, policies, and procedures also comply with applicable regulations in whatever jurisdictions it operates.
Cedars-Sinai personnel looking for more information on the validation of SourceDrive can view relevant documents here: https://cedars.box.com/s/2t14qqqdt8my4254ftkntj2358mw112w