Regulatory Open Forum

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  • 1.  electronic signatures

    Posted 12-Jun-2019 19:22
    There are different types of signatures defined in Part 11. Here are the three I need clarification on: 

    Digital signature 
    Electronic signature 
    Handwritten signature

    For handwritten signatures (also known as electronically captured handwritten signatures), is it true that an approver can just sign off with a stylus, and that's equivalent to a traditional wet-ink signature?  In this case, one can use Adobe Sign to sign off? It seems like a way to get around the actual electronic signature requirement. In this case, Part 11 does not apply.

    Also, between digital signature and electronic signature, I have seen some companies go for Adobe digital signatures rather than implementing electronic signatures (e.g. through DocuSign or any of other dozens of e-signature vendors).  Is one type of signature preferable to the other?  Note, the company plans to store all documents (procedures, and records) in an electronic format, but do so in a way to comply with Part 11. It's a very small company of under 10 people so it would be great to implement a cost-effective electronic signature system.  Can somebody provide some insight into this?

    Karen Zhou

  • 2.  RE: electronic signatures

    Posted 13-Jun-2019 04:38
    Hello Karen,

    First would comment whatever signature process you want to implement in your organisation, select one passed on your processes, maturity of your quality system, and where your documents would be transmitted (if they are being sent externally).  More importantly make sure your internal procedures reflect the process for how you manage electronic or digital signatures.

    There can be a distinction between electronic and digital signatures, where many will use electronic signature which is actually still handwriting their signature only in electronic format, i.e. if you have bought an item in a store using credit card and signed on the little screen with your signature.  An electronic signature can also be something where you just select an option that you "sign" the document electronically such as a version of DocuSign.

    The difference between an electronic signature and digital signature is with a digital signature there is a date stamp, usually a time stamp, and also potential a certificate accompanying the signature.  A digital signature embeds a token, certificate, or personal identifier showing who signed.  A digital signature is most secure because the person not only needs to login to the system, but must also digital sign with another password or token.  You can even take it to the next level with biometric digital signature, so not only digitally signing with a token, but using biometrics like a fingerprint or eye to confirm identity.

    Electronic signatures only are legally binding based on Acts, regulations, and laws passed in most countries.  The need for digital signature is only is there is security concerns or identity needs associated with the signature.  Though some programs like Adobe already have digital signature built into the program such as if using full suite of Adobe Acrobat can include this version just an electronic signature.

    It can be quite complex on which to choose, so that is why I mention at the beginning to really determine based on your quality system, documentation, and where your records will be transmitted what type of signatures you need.  Keep in mind most electronic signature options today a compliant to Part 11 requirements (don't get hung up on Part 11 it is more important your eQMS systems are validated).  However, if you are making eSubmissions to FDA than getting a program providing digital signatures may be more appropriate.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 3.  RE: electronic signatures

    Posted 13-Jun-2019 14:51
    here's a good and brief description of the differences between the electronic and digital signatures:

    If you look strictly at the requirements defined in 21CFR Part 11 Subpart C-Electronic Signatures (also see definitions 11.3 b 5 and 7), then a simple electronic signature (e.g. image or a doodle) may be viewed by some as insufficient.
    However, I have yet to witness and hear of an auditor asking if an electronic signature is protected (encrypted) with a digital certificate.
    Interestingly, the Part 11 Guidance document lists a few areas where the agency intends to apply enforcement discretion, for example, validation or audit trails; but, the guidance also states that the agency intends to enforce requirements related to electronic signatures.

    Michael Zagorski RAC
    Pittsburgh PA

  • 4.  RE: electronic signatures

    Posted 14-Jun-2019 00:30
    Also note- If you choose to do an electronic signature  or digital signature method, you will need to qualify the software you're using is capable of meeting Part 11 requirements. You will need to write a protocol with requirements that you verify via testing. You will also need to keep records of the result of the testing.

    Isabella Schmitt
    Regulatory Affairs Consultant
    Houston TX
    United States