Have you signed your electronic documents today?

In a computerized world, paper-based management systems are forced to convert, most kicking and screaming out of their file cabinets. Particularly difficult is QMS software, which is really derived from paper-based Standards, based on checklists and desirable processes that should lead to good outcomes.

Today’s eQMS software comes in different shapes and sizes mostly dependent on the nature of the company and its specific needs to meet different standards and regulations. They also come at different prices.

One of the main criteria for an eQMS is to have implemented an electronic signature.

Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.


“Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the individual’s handwritten signature.”

21 CFR part 11.3 (7)


The easiest ways to satisfy this requirement to ensure that a particular e-signature belongs to the right user is to allow the user to set their own personal codes.

One very effective method is to use a PIN number, just like your bank account. But unlike your bank accounts, you should have to log in to the eQMS system first, so they know who you are signing as.

The personal PIN code should be modified only by its owner. They should also be unique to that user.

When we are talking about quality management and ISO/FDA compliance, these signatures should be traceable and attachable to documents and cover approvals/reviews for documents and records. Some systems provide a full historical trail of who signed the document or record and when it was signed, which is also a crucial aspect of the audit.

Implementation and use of this function shouldn’t represent an issue for any eQMS or other management software since, an electronic signature is accepted and used for a long time and in everyday life (credit card payments, unlock mobile phone…). Just be careful and keep your PINs and passwords safe!

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4 replies to “Have you signed your electronic documents today?”

  1. Vanesa says:

    I love your topics and cant wait to read next one!

  2. Ben Bohn says:

    Hi ,great article. I used to work on similar software. Not good as this one for sure, but similar. I know how this programs are necessary for document control and getting FDA approval for certain medical devices. They are essential for this type of research.

  3. Kerry Jonas says:

    How can an e-signature be traceable and attachable to documents, how does this really work in a qms software and which one could be the right software for it?

    Thnks

  4. Sofia Nascetti says:

    Like this article. But I would like fully to understand how to “verify” that PINs satisfy 21 CFR Part 11 requirements?

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