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21CFR Part 11
21CFR Part 11 add-on is designed for companies who are required to comply with FDA requirements in order to issue products on the American market related to consumers and patient health and safety. This add-on can be applied for any other regulatory agencies having similar requirements.
FDA requirements for IT systems
Part 11 of chapter 21 of Code of Federal Regulation requires effective and proven data management from companies whose products need to be FDA approved. These companies must protect data integrity, continuity, authenticity, confidentiality and traceability.
Regarding records management 21CFR Part 11?s requirements are two-fold:
- Agent authentication should be secured,
- All system events should be tracked and registered in a complete Audit Trail
Ennov's answer
To enable its customers from the pharmaceuticals, chemicals or cosmetics industries to be FDA compliant, Ennov provides a 21CFR add-on on top of Doc, Dossier, or Process that guarantees:
- Agent authentication is secured thanks to double validation process of all documents and workflow steps,
- A separate audit trail database keeps detailed track of all changes made in the system.
Activating the 21CFR add-on does not require any additional development, which turns into important time and money savings.
All organizations that wish to keep very strict records of data changes on documents and workflows might also be interested in this add-on.
We can provide a complete 21CFR part11 module presentation .