What is the status on this?
-Another life sciences company looking to leverage Box Sign and waiting for it to be Part 11 compliant.

Was looking into replacing docusign with BOX Sign, but working with pharma industry and switfh until Sign is Part 11 compliant

Please implement the Part 11 compliant features, most notably separate user and password entry for each signing, even if at first you won't be providing a "validation package".

We are eager to see Box Sign updated for compliance with 21 CFR Part 11 compliance. As a regulated medical device company we won't use Sign until it is Part 11 compliant. I'd be happy to assist with specifying the updates required for compliance.

We are a life sciences company that requires this feature for many of our documents. This feature could help us consolidate many processes to within Box.

Invitae Corporation is asking for BoxSign to be CFR Part 11 Compliant

We are using Box for the management of regulated content with a controlled life cycle (Life Sciences industry), and we cannot use Box Sign unless it is CFR Part 11 compliant

Flagged by a large ANZ Life Sciences customer that this is a requirement. Thanks in advance

We have unmet needs for use cases where the Box Sign feature would provide
value to our clients - purchase order approval workflows and CFR-11 validated
clinical workflows to name a few. Thanks in advance.

Lesser services have this option. This is required for many users.

Very much needed

This feature would help us streamline our workflows and is required for Life Sciences industry.

BT have a number of LS & Insurance clients that would see the benefit and ROI in Box & Box sign however 21 CFR part 11 is an absolute must and is always the first question asked having a defined date on this would be great! acaracciolo@box.com

Highly required

In the moment almost every prospect/customer in LifeSciences asks for that certification. I have a boxnote with customer-names who are highly interested or in need for that certification (in the moment 8 customers). If you are interested reach out to hmeckel@box.com

Box Sign Part 11 Signature should meet the following criteria:

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
Sec 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Sec. 11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

CFR Part 11 compliance for Box Sign is a must have for our organization to fully move to Box Sign for our electronic signature solution.