Hi all, I do QA/RA for a medical device manufacturer, and I'm looking for a generally-accepted list of types of electronic records that are covered / should be validated per U.S. Regulation 21 CFR Part 11 (Electronic Records; Electronic Signatures). I would greatly appreciate if someone could point me to either a useful book / guidance document / industry blog post that covers this topic.
In particular, I'm most confused by this FDA Guidance (https://www.fda.gov/media/75414/download) which says that "Definition of Part 11 Records: Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures): Records submitted to FDA, under predicate rules ... in electronic format ... However, a record that is not itself submitted, but is used a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format."
This stipulation is frankly confusing. I'm guessing it means that there are VERY FEW types of electronic records that are excluded.
I'm looking for a simple list of included and excluded, that covers a lot of common situations. For example:
This question may seem trivial to experts, but please keep in mind that as a newcomer to this subject, the scope is incredibly poorly defined. I've already made a homemade guide for identifying complaints vs. non-complaints but this is beyond me. I've read the FDA Guidance, the 'predicate rules" related to medical devices (21 CFR Part 820 and 21 CFR Part 11), and the other posts here on Elsmar Cove, but couldn't find anything.
Yes, I understand that it's my responsibility to thoroughly analyze all regulations and my own business activities to determine what constitutes an "electronic record", but there are also situations which are clearly obvious to those who have experienced it already. I would really appreciate any help before having to resort to a questionable consultant.
In particular, I'm most confused by this FDA Guidance (https://www.fda.gov/media/75414/download) which says that "Definition of Part 11 Records: Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures): Records submitted to FDA, under predicate rules ... in electronic format ... However, a record that is not itself submitted, but is used a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format."
This stipulation is frankly confusing. I'm guessing it means that there are VERY FEW types of electronic records that are excluded.
I'm looking for a simple list of included and excluded, that covers a lot of common situations. For example:
"Electronic Records" included in Scope of 21 CFR Part 11 | Not Included in Scope |
| Training Records that are signed. | A non-signed evidence of competency/training. |
| A signed data intake form. | A raw data spreadsheet exported by a medical device, for complaint investigation. |
| Use of excel as a database, where the data is kept only in the excel file. | Use of excel as a tracking tool, where actual data is kept in separate records. |
| A distribution record of a medical device. | A simple list of customer names. |
| A DHF document that must be submitted in a 510(k) such as a software requirements specification (SRS). | (Do any exclusions exist for DHF?) |
| A DHF document that is not submitted in a 510(k) such as either a hardware technical requirements document or a hardware test for battery life. | (Do any exclusions exist for DHF?) |
| A MDF / DMR record such as a Bill of Materials (BOM). | (Do any exclusions exist for MDF / DMR?) |
| A DHR record completed form such as manufacturing traveler, installation, and/or service. | A DHR record such as raw data logs from the medical device being worked on. |
This question may seem trivial to experts, but please keep in mind that as a newcomer to this subject, the scope is incredibly poorly defined. I've already made a homemade guide for identifying complaints vs. non-complaints but this is beyond me. I've read the FDA Guidance, the 'predicate rules" related to medical devices (21 CFR Part 820 and 21 CFR Part 11), and the other posts here on Elsmar Cove, but couldn't find anything.
Yes, I understand that it's my responsibility to thoroughly analyze all regulations and my own business activities to determine what constitutes an "electronic record", but there are also situations which are clearly obvious to those who have experienced it already. I would really appreciate any help before having to resort to a questionable consultant.
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