Electronic/digital signatures

[PHW]

A small company, we don't have an EDMS where we can sign documents electronically, currently still using wet ink for everything. Looking to use a service provider software. What must we look for? Any advice appreciated, thanks.

[Orr]

Firstly you need to identify exactly what you want the system to do before contacting a few companies explaining your requirements, and ask for a demo of what the software can do and any related documents. If you can be shown a live system in use on a site,that would be even better.
Things to consider;
1. Stand alone/ hosted system?
2. Ease of access on site/ off-site
3. Is there a separate charge for additional users?
4. Can you upload WORD, EXCEL and other types of files you use
5. Security and access levels/ back-ups available
6. How does the electronic/ digital signature work- does this comply with your regulations?
7. Ease of loading/ unloading documents.
8. Audit trail
9. Cost/ benefit

bw

[PHW]

Thank you for your help! I will look into this with these points in mind. Point 6 - Is there a list to be found anywhere of the regulatory requirements for global clinical research, accreditations etc?

[bujjireddy]

Electonic signature requirements:

1. Electronic signatures must include information to indicate theprinted name of the signer, the date and time of the signature and
the meaning of the signature.

2. Electronic signatures must be forever linked to their respective
records.

Regards,
Bujji Reddy.

[Mario Corrado]

Do you think that, as bare minimum, it could be acceptable from a regulatory point of view to have just

• An electronic token (USB key with digital identity)
• Adobe Acrobat (which can use electronic signatures)
• A SOP

We just have Acrobat and we were wondering whether it could be enough.

Thanks

MC

[a123456]

There is a really interesting paper by HRA and MHRA "Joint statement on seeking consent by electronic methods" Sep 2018 which has a section on electronic signatures.