21CFR part 11

Ennov5 21CFR part 11 module is especially valuable for companies who wish to sell products on the US market that have an impact on the health of consumers and patients. They have to obtain an authorization issued by the FDA (Food and Drug Administration) after proving full compliance with 21CFR part 11 regulatory requirements.

FDA requirements for information systems

FDA requirements that concern information systems are defined in the Code of Federal Regulation (CFR), chapter 21, part 11. Data management has to comply with rules that guarantee traceability, confidentiality and integrity of all information stored in each database.

The two main requirements on electronic records are the following:

• Secure authentication of the user
• Audit-trail of all events in the system

Ennov’s response

Ennov designed and developed a specific module to help its clients in life science industries obtain their FDA certification. This module works as an add-on to Ennov5 Doc, Dossier and Process. It guarantees:

• Management of electronic signatures with an additional authentication before validating a document or a workflow step
• Recording in a separate audit trail database of all actions done in the system that have an impact on the data (creation / edition / deletion)

A standard module for an easy implementation

Activating Ennov5 21CFR is done through a very simple configuration, no development is needed. This is of course a tremendous advantage for your system validation. This module is also available for any organization that wishes to implement a total control of electronic records, not necessarily for FDA compliance purposes. This module is also available for any organization that wishes to implement a total control of electronic records, not necessarily for FDA compliance purposes.