Requirements ยท Healthcare
FDA 21 CFR Part 11
Electronic records and electronic signatures. 3 Moraph products list it under “Requirements it supports”. The products support this requirement; meeting it remains your organization’s responsibility.
About the rule
What it is
21 CFR Part 11 is the US Food and Drug Administration regulation that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and generally equivalent to paper records and handwritten signatures. It applies to records that FDA regulations require organizations to keep or submit to the agency, for example in drug, biologic and medical device manufacturing and in clinical research.
Source: 21 CFR Part 11 (eCFR). FDA 21 CFR Part 11 in the glossary. This summary is for orientation only; read the rule itself or ask your counsel for what it requires of you.
Citations
How the products cite it
The exact wording on the product pages, with how many products use each.
- FDA electronic records and signatures (21 CFR Part 11) 2 products
- 21 CFR Part 11, for research records where it applies 1 product
For what it requires of your organization, read the rule itself or ask your counsel. FDA 21 CFR Part 11 in the glossary.
Products
The 3 products that support it
Clinical Trial Patient Recruitment App
Patient-facing mobile app for eConsent, retention, and adverse event reporting in trials.
Lists:
- FDA electronic records and signatures (21 CFR Part 11)
Cloud Content
Box storage for unstructured data (research papers, policy docs) under a business associate agreement, configured to support HIPAA safeguards. Sharing and retention decisions remain yours.
Lists:
- 21 CFR Part 11, for research records where it applies
Grant & Site Payment Manager
Automates financial reconciliation for research sites based on patient milestones.
Lists:
- FDA electronic records and signatures (21 CFR Part 11)
Not sure which requirements apply to you? Request a gap analysis. All requirements: Requirements our products support.