RSign eSignatures with encryption are used with e-prescriptions, and within the medical device, health care, life sciences, pharmaceutical, and biotech industries. RMail email encryption is commonly used to meet the same privacy needs.
Watch full video of Heather Dunn discuss RSign at Optimize!2020.
Claims Supervisor, Mercury Insurance
The Food and Drug Administration (FDA) has published guidance for compliance with specific regulations in 21 CFR Part 11. This guidance is intended to describe the FDA’s current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). RPost Services Support Compliance with FDA Guidelines on 21 CFR Part 11.
Preserving the RMail Registered Receipt™ and RSign® signature certificate associated with any document sent by email or sent for electronic signature with RMail and RSign automatically preserves a time-stamped audit trail and original content of the document (and email message body text content as well as electronic signature). This is preserved in the form of a Registered Receipt™ email record or RSign signature certificate, which can be stored by the sender in any normal email box, email archive, or document archive (or with RMail or RSign services online depending on the service options and features). These electronic “receipts” are self-contained, can be independently authenticated, and can re-construct an authenticated time-stamped original content in a human readable and standard electronic format.
One can then optionally elect to preserve the original message and documents as that information is preserved with the transmission audit trail, within the electronic receipt itself.
With regards to the FDA guidance on 21 CFR Part 11, “Electronic Records; Electronic Signatures,” the RMail and RSign services simplify compliance with at least the following requirements. If one is emailing documents to the FDA, RMail and RSign can automatically add authenticated electronic signatures and provide a record returned to the sender that complies with Part 11; the process is as easy as attaching a DOC or PDF to an email and sending (sending via RMail or RSign).
Excerpts of important elements of FDA guidance on 21 CFR Part 11 as it relates to RSign and RMail follows:
The Food and Drug Administration (FDA) has published guidance for compliance with specific regulations in 21 CFR Part 11.
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