What is an Electronic Record & how to manage them in Confluence?

From FDA 21 CFR 11.3(b)(6) “Electronic Record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”

The definition is quite broad and includes almost every type of electronic data. There are anyway some distinctions, including those described in the FDA’s own guidance. This distinction is important as not all “files” are intended to be covered by 21 CFR 11 .

Electronic Records intended to be covered by 21 CFR 11:

1. Records that are required by the CFR and are maintained in an electronic format rather than paper format, E.g.: Procedures, Templates, Work Instructions; Outputs of the Quality Management System (QMS), records such as minute of management reviews, requirements for a product, risk management documents, CAPAs, NCs, Change Management records, Complaints, etc.
2. Electronic copies of paper records that are actively used and relied on;
3. Records that are submitted to the FDA in electronic format (and by extension to Notified Bodies and regulatory agencies);
4. Electronic signatures (they fall under the same controls as Electronic Records).

Electronic Records NOT intended to be covered by 21 CFR 11:

Any other record that a Company maintains in electronic format and is not required by the regulations and is not used to perform controlled activities. If the Company’s QMS requires to create a record as part of a process covered by the regulations, the record is covered by 21 CFR 11 regardless of whether the regulations require it.

You can keep any record that is not covered by 21 CFR 11 in your Company’s Confluence, applying relevant permissions to users in your team.

For electronic records that are covered by 21 CFR 11, Confluence itself will not suffice and you will need a Document Management solution to fill the gaps. SoftComply Document Manager app on Confluence Cloud is out-of-the-box compliant with 21 CFR 11 requirements and you can try it out for free for 30 days. It includes workflows, electronic signatures, permissions management and overall document lifecycles.

?? Do you want to learn more about compliant Document Management on Confluence? Book a call with our team .

?? Are you going to Medica 2024? Book a slot to meet us at our stand:

This article was originally published in SoftComply blog .