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.