What is an Electronic Record and 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:
- 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.
- Electronic copies of paper records that are actively used and relied on;
- Records that are submitted to the FDA in electronic format (and by extension to Notified Bodies and regulatory agencies);
- 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.
| Record | Is it an Electronic Record? |
|---|---|
| Quality Manual | Yes |
| Procedure for Validation of Software tools | Yes |
| Procedure for storing food in the canteen | No – this is not a “controlled process” according to regulations (unless it affects others) |
| Validation results for a manufacturing process | Yes |
| Attachments to the above document, e.g. screenshots, pictures, data logs | Yes |
| Release notes for a software product | Yes |
| Binary files of a software product | No – technically this is not a “record”, but there are specific requirements on how to store and preserve software versions that are very similar, ref. IEC 62304 for example. |
| Emails, SMS | No – unless they are somehow related to QMS processes, e.g. complaints received by email. In this case it is good practice to make a copy of them and store them in a proper Document Management System. Please note that legal aspects of retention of correspondence are not covered by 21 CFR 11. |
| Audit logs of a validated software tool | Yes |
| Audit log of the software of a manufacturing piece of equipment, stored on the machine itself | Yes |
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.
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