Electronic signatures- Document control systems

[Rashmi]

Please can someone advise me if an electronic signature ( from a document control system) is acceptable to evidence that staff have read SOPs?

Are there any particular things that need to be considered before implementing this, instead of having them sign an actual paper SOP?

Many thanks

Rashmi

[Transfusion Guru]

If an electronic signature is good enough for a cross-match, I would think it would be good enough for signing that a person has read an SOP. After all, with a secure password system, nobody else should be able to sign for them.

[Rashmi]

Good point Transfusion Guru!
I am not yet familiar with "electronic signatures"- from what I gather (and could easily be wrong!), staff are informed of a new SOP, and as they acknowledge the email/ open this - a message would ping in the system to indicate the SOP was read, and this doesn't seem right, though not much different from someone just signing an SOP without reading.
With a cross-match, you are acknowledging various rules/ questions throughout the process and physically authorising the final issue- so I would have thought this was different.

Anyway, it is quite good fun to question every aspect of these things and see how they can be improved- I learn so much by bouncing ideas off others!

[Transfusion Guru]

Ah, I didn't realise that your computer was set up so that, as soon as they open/acknowledge the email, the system would say that the SOP has been read. That sounds a bit odd to me, and I wouldn't accept an electronic signature under those conditions. I would want the programme changed, so that the individual has to actively "sign" to say they have read the document.

[Stephen-Grayson]

Acknowledgement by opening or returning an email does not fulfil the requirements of an electronic signature, and in the example given above does not clearly indicate that the person has read and understood the document.

An electronic signature must clearly identify the person performing the action, and time stamp it. This typically requires the person signing to verify their identity at the point the electronic signature is applied (i.e. user name / password). This ensures, as far as one can, that the signature is attributable to the person signing, and not just a consequence of them being left logged on to a system and another person signing on their behalf. Compliant electronic signatures are equivalent to a hand written signature and must demonstrate the principles of ALCOA, as outlined in the MHRA data integrity guidance and by others.