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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.

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.

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. Just be careful and keep your PINs and passwords safe!

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Comments (1)

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I love your comic Cup of Joe. It is funny and on the other hand, the explanation is well presented.

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