Electronic signatures are not a 1-1 replacement for every place you might use a paper signature or initial.

This has implications when you’re taking a previously paper-based process and going digital - to try to convert the SOP step-for-step and record-for-record into the digital medium would be to lose some of the benefits of a digital workflow.

Let’s say you’re moving a document review and approval workflow to a digital system.

If you’ve chosen your software carefully based on pre-written requirements, you should have something that implements various niceties in the name of compliance, like:

• audit trails and logging
• individual user accounts (or leveraging those of the underlying platform)
• access controls

So do you really need to keep the “routing form” that used to follow documents around to capture reviews and dates? No! The system keeps track of who did what already.

Similarly, do you really need a formal electronic signature of each of the reviewers, or is the fact that they logged in and clicked on the button to send the document along sufficient? Of course, that depends on your use case. But keep this in mind: in many cases, the regulations may only require the signatures of one or two specific roles for approval.

For example, the FDA GLPs say : “The date of approval of the protocol by the sponsor and the dated signature of the study director.” The GPPs say that all "methods and procedures that, prior to their implementation, have been approved by the QAP".

In either case you might have a whole whackload of reviewers and approvers outside that, especially if you’re putting the thing through a change control process - department or peer reviews, quality reviews, management, etc. - but in the end the only electronic signatures on the record that need to be there from a regulatory standpoint are a) the ones they name and b) anything else that you've required in your SOP, since the regulations require you to follow your SOPs.

But you can replace some of those in the SOP if some other digital record meets the bill.

Why is this important? Because an electronic signature is not always available, or practical, or convenient, or as traceable as you might need it to be.

Until next time, thanks for reading!

– Brendan

p.s. Enjoy this message? Read more at the Hyland Quality Systems website.