Electronic Signatures (21CFR Part 11) - Must They Appear on Printed Documents

fcowdery

Starting to get Involved
#1
We have just implemented a new tool (Oracle Agile) which allows for electronic signature sign off of documents within the application workflow.
However when we print the documents, the signature does not appear on the document.
Instead we are considering putting the following generic statement on each document:
[FONT=&quot]All approvals are maintained in the Document Control System. Refer to the Document Control System for the current controlled revision and approval records. Draft, archived, and obsolete revisions are not to be used. Access the Document Control system to verify revision.[/FONT]

Question: Must a replica of the electronic signature appear on the document itself once printed for use at point of use or does this statement satisfactorily replace the physical electronic signature and keep us in compliance with Annex 11 and 21CFR11.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Electronic Signatures - Must They Appear on Printed Documents

Good day fcowdery,

The short answer is NO.

You don't state what standard you are referring to, but I can offer that none of the standards I work to require approval evidence on controlled documents as you've described. When I review approval of controlled documents I am happy to consider a range of options. Some clients keep a signed hard copy on file. Some use 2010 Microsoft Outlook's vote feature to record approvals, and leave no evidence of that approval on the document whatsoever; others use a proprietary software application to do the same thing.

In short, I am looking for approvals but they do not need to show up on the documents themselves.

I hope this helps!
 
W

WoodDuck

#3
Re: Electronic Signatures - Must They Appear on Printed Documents

Hello flowery,

The name of the approved would need to be displayed on displayed and printed copies.
See paragraphs (a)(1) and (b) from 21 CFR 11 below.

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.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

I've been told a system user name is acceptable in place of a persons legal name if there is a list on file which identifies the person's user name.

Regards,
Jim
 

fcowdery

Starting to get Involved
#4
Thank you Jennifer and WoodDuck for your responses.

Jennifer-
We are medical device manufacturer. We need to comply with ISO13485 and EU GMP Annex 11. Additionally, we need to comply with 21CFR820.40 and 21CFR11.
 
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v9991

Trusted Information Resource
#5
Re: Electronic Signatures - Must They Appear on Printed Documents

The name of the approved would need to be displayed on displayed and printed copies.
See paragraphs (a)(1) and (b) from 21 CFR 11 below.

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.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

:applause:

in short, Yes you need to outline the above details of Electronic Signature in the approved document. Further more, pl. evaluate the approach to meet the requirements of 11.50(b) above.

btw,have you checked the options available(offered) by the software vendor?(Oracle Agile!)

whichever approach you take, it need to be supported through policy-verification-system-maintenance processes.
 

fcowdery

Starting to get Involved
#6
Thank you everyone for your responses.

V9991-
We have discuissed this issue with Agile integrator and were told for a 4-5 figure fee they would be able to customize (write a groovy script) our Agile Software. Being a small start up company, this is a big number for us to afford at moment.

Anyhow, than you all for the sound guidance.
 
M

MIREGMGR

#7
I'm not directly familiar with Oracle Agile's implementation, but I'm very surprised that it might be thought to not be compliant with all of the major document and record control requirements. Have you asked your Oracle Agile representative--not the integrator, who has a financial motivation to decide that the system needs customization--to provide you with the regulatory validation documentation for the rules to which you are subject?
 
#9
For ISO 13485 compliance, I want use a document change order process that lists all revised documents and relevant signatures. The change order cover sheet will be signed and the document revisions will be tied to the change order number.

Do printed documents need signatures in that case?
 

v9991

Trusted Information Resource
#10
For ISO 13485 compliance, I want use a document change order process that lists all revised documents and relevant signatures. The change order cover sheet will be signed and the document revisions will be tied to the change order number.

Do printed documents need signatures in that case?
In short, Yes, Here's the reason.

and as per the 21 CFR part 11, any document/activity managed in electronic form to comply with predicate rule, shall comply with e-sign/e-record requirements.

in fact, all the changes pertaining to part 820 requirements you want to handle using the software.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

for eg., the above activity/document is relevant to following rule...
Subpart D--Document Controls
Sec. 820.40 Document controls.
(b)Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
hope this helps.
 
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