This week we will be breaking down Subpart A – General Provisions, Sec. 11.2 Implementation of the Part 11 regulations and explaining in simple terms what each aspect of the regulations mean to you.
If you missed Part 1 of this series click here to read about Sec 11.1 Scope.
The actual text of the regulations appear in red and my explanation of the regulation’s appear in black.
Subpart A – General Provisions
- 11.1 Scope
- 11.2 Implementation
- 11.3 Definitions
Subpart B – Electronic Records
- 11.10 Controls for closed system
- 11.30 Controls for open systems
- 11.50 Signature manifestations
- 11.70 Signature/record linking
Subpart C – Electronic Signatures
- 11.100 General requirements
- 11.200 Electronic signature components and controls
- 11.300 Controls for identification codes/passwords
Subpart A – General Provisions: Sec. 11.2 Implementation.
(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.
In short for all records that are created and stored in your organization but are NOT required to be submitted to the FDA they still must adhere to the regulations set forth in 21 CFR Part 11. In simple terms electronic records can be used instead of paper and electronic signatures can be used instead of handwritten signatures.
(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:
As stated above all records that are created and stored in your organization but ARE required to be submitted to the FDA must adhere to the regulations set forth in 21 CFR Part 11. In simple terms electronic records can be used instead of paper and electronic signatures can be used instead of handwritten signatures provided that:
(1) The requirements of this part are met; and
21 CFR Part 11 is adhered to and…
(2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.
The document(s) been submitted fall under the category of documents that the FDA will accept electronically. The documents that the FDA submit electronically can be found in the public document No. 92S-0251
To summarise what is in this docket:
“The Food and Drug Administration (FDA) is establishing a public docket to provide information on submissions the agency is prepared to accept electronically. FDA is taking this action to provide easily accessible notice to the public when agency receiving units are prepared to accept electronic submissions and to promote the use of electronic technology.”
Those documents that are submitted to the FDA in electronic format that are not in this docket will not be accepted as official documents, only the paper versions of these documents maybe submitted and will then be considered official.
If an organization is submitting electronic versions of documents, they must first consult with the FDA and get approval as to the type of electronic file that is permitted.
Summary
This aspect of the regulation is pretty clear, whether you are using electronic documents in-house (i.e GxP documents) or if you are submitting documents to the FDA in electronic format that are within the scope of public docket No. 92S-0251 then they must adhere to the regulations set forth in 21 CFR Part 11.
