My company designs and develops medical devices for our customers, and, as a part of that process, we send approval letters to the customer as part of our procedure for design verification. The letter can be signed approved, approved w/ comments, and not approved. Usually, the customer prints the letter, signs the document, scans the letter, and returns the document through email.
Recently, a customer requested that this .pdf letter become a form that can be signed electronically. Should my company require documentation from the customer that this signature is valid? For instance, do we need to request documentation that this signature is compliant with Part 11?
Thank you in advance for your responses.
-------------------------------------------
George Reed
Fort Wayne IN
United States
-------------------------------------------