Collaborate Disseminate
21 CFR Part 11’s Subpart B for Electronic Records has a section on ‘Controls for Open Systems" stating that:
Persons who use open systems to create, modify, maintain, or transmit
electronic records shall employ procedures and control… Continue reading Is Digital Signature really necessary for an open system considered by FDA’s 21 CFR Part 11?
My organisation, say Acme, is building an e-signature platform where global businesses sign up and use the platform to send out e-signature requests. And when signers in a particular e-sign request sign the document, Acme must digitally si… Continue reading How to feasibly digital sign high volume documents with CA issued digital certificate?
I have some basic questions regarding eIDAS and ‘Advanced Electronic Signatures’.
Say, if I create a product under my company Acme Inc that offers a simple electronic signature where I sign every completed document digitally with a digital… Continue reading Does a signature service provider level digital certificate for electronic signature comply with eIDAS requirement for Advanced Electronic Signatures?