Title 21 CFR Part 11 is the part to the Code of Federal Regulations (“CFR”) which is established by the Food and Drug Administration (“FDA”) which provides requirements for electronic records and electronic signatures. The purpose of this part is to ensure that electronic records and electronic signatures can be trusted in a typically similar manner as paper records and ink signatures (“wet signatures”).
It is pertinent to note that Life science organizations and device manufacturers that are regulated by the FDA are essentially required to follow the CFR as provided under Title 21 Part 11.
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An 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. As mentioned above, the purpose of Part 11 is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures. Hence, all the electronic records that are subject to and used for regulated purposes are subject to Part 11.
When electronic records are signed, the system records the following items as part of the electronic signing process:
According to subpart B which deals with electronic provisions, the Organizations using electronic records must establish and document procedures and controls that ensure the following qualities in their electronic records:
In documented procedures and controls the following mechanisms must be addressed:
Above mentioned mechanisms would apply to the “Closed” category of system. Systems that fall into the category of “Open” (as defined in Subpart A) require additional procedures/controls. The above-mentioned mechanism would still apply in addition to whatever makes more sense given the risks and available options to ensure the same level of record qualities.
Electronic signatures must include the printed name of the signer, the date and time of the signature, and the meaning of the signature. Electronic signatures must be forever linked to their respective records.
For regulated records that are not submitted to the FDA, an organization can use electronic instead of (or in addition to) paper, as long as it can prove that its electronic records comply with Part 11. For regulated records that are submitted to the FDA, an organization can use electronic records instead of paper records as long as the following two conditions are met:
All the electronic records that are used for regulated purposes which apply to all FDA program areas are subject to Part 11 and were intended to permit the widest possible use of electronic technology, compatible with the FDA’s responsibility to protect public health.
Moreover, the term “Part 11” applies to records and signatures in electronic form that are created, modified, maintained, archived, retrieved, transmitted or submitted, under any records requirements set forth by the FDA regulations/predicate rules.
Note: The types of e-records that the FDA accepts are listed in public docket No. 92S-0251.
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The FDA allows the use of electronic signatures instead of pen and ink signatures (also known as “wet signatures”) in order to facilitate conducting of the business digitally. A compliant electronic signature must include the following:
The requirements as listed under subpart C on electronic signatures are as follows:
As discussed above, the regulations in Title 21 of CFR, Part 11 set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper, there are various obligations that are required to have complied under Title 21 of CFR, Part 11. This part particularly provides for various regulations that apply to electronic records and electronic signatures as required by the FDA. The regulation made electronic records and signatures as valid as paper records and handwritten signatures. Part 11 does not mandate the use of electronic systems. Rather, it specifies the requirements for companies that choose to use digitized systems in their compliance efforts.
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Disclaimer: Certinal is making available the information and materials in this article for informational purposes only and is meant to help companies understand eSignature’s application in a legal framework. Laws change rapidly and Certinal makes every reasonable effort to keep the content of this article current, hence Certinal makes no claims or representations that the information contained in this article is true, accurate, correct, or current. The law is different from jurisdiction to jurisdiction, and even similar laws may be interpreted differently in different courts or in different places. Since these factors differ according to individuals and businesses, Certinal is not liable for any consequence of any action taken by any third party relying on material/ information provided under this article. The contents hereof should not be construed as legal advice in any manner whatsoever. In cases you require any assistance; you must seek independent legal advice.