SOP's & Part 11 - Including Sec 11.50 Signature Manifestations

[fheatherly]

We recently had an audit finding for the fact that our SOP's and work instructions are stored in a Document Management Software and when the SOP's & WI's are called up by the user the approval/review information is not stored in the actual "Electronic Record". As per Sec 11.50 Signature Manifestations.

When a user brings up the SOP's or WI's by use of the Document Management system they are bringing up a read-only copy of the the document in it's native format (Word, Excel, PDF).
The approval/reviews are conducted electronically (which is Part 11 compliant), therefore there is no way for them to be included on the actual SOP's or WI's themselves.

The approval/review information is available to the users, but not in the actual Word, Excel or PDF document that the user brought up.
I know that as per Sec 11.10(k) we have to have adequate controls over the distribution, access to and use of the documentation, which we do, but it was our understanding that the actual SOP's and work instructions themselves were not subject to Signature Manifestation section.

The whole premise for Part 11 was paper reduction, but if we do it the way that auditor suggests we will have to go back to a paper approval/review system so that they can be included in the documents, which we don't want to do.

[Wes Bucey]

The curse is that the audit trail must be relatively straightforward to connect documents with authors and approvers to demonstrate the material has gone through the process. It seems you may need an IT guru to write a little code to annex/append an approval sheet to each document, listing the approvers and dates of approval.

I say "curse" because this is ultimately a regulatory issue versus a judgment call by an individual auditor on the minimum requirements for document management.

I am aware that some of the very big software publishers of electronic document management systems have special modules for dealing with FDA requirements. Why not examine some of those to see how the issue has been handled by others?

[Linda W]

We are in the process of evaluating and purchasing a new Global EDMS (electronic Document Mgmt system). None of them have approval and review information actually on the document itself that the user reads but it is contained in an information sheet readily available to the user. FDA Part 11 just like any other standard is up for interpretation and what this auditor has required, based on what I understand you to say, is their interpretation but not industry standard from what I have experienced during our investigation phase of EDMS systems.

I deal with Part 11 compliance issues all the time in my job and it among colleagues and other experts there isn't always consensus. What I tell people is to understand the "intent" of the standard and then find a way to comply that makes good business sense.

My 2 cents,
Linda

[Al Rosen]

In Reply to Parent Post by fheatherly

We recently had an audit finding for the fact that our SOP's and work instructions are stored in a Document Management Software and when the SOP's & WI's are called up by the user the approval/review information is not stored in the actual "Electronic Record". As per Sec 11.50 Signature Manifestations.

When a user brings up the SOP's or WI's by use of the Document Management system they are bringing up a read-only copy of the the document in it's native format (Word, Excel, PDF).
The approval/reviews are conducted electronically (which is Part 11 compliant), therefore there is no way for them to be included on the actual SOP's or WI's themselves.

The approval/review information is available to the users, but not in the actual Word, Excel or PDF document that the user brought up.
I know that as per Sec 11.10(k) we have to have adequate controls over the distribution, access to and use of the documentation, which we do, but it was our understanding that the actual SOP's and work instructions themselves were not subject to Signature Manifestation section.

The whole premise for Part 11 was paper reduction, but if we do it the way that auditor suggests we will have to go back to a paper approval/review system so that they can be included in the documents, which we don't want to do.

This is quite interesting, as the FDA does not have a requirement in the predicate rules (21cfr820.40) for the approval to be included on the document only that it be documented. I might argue that you are meeting the requirement of the predicate rules and as such are in compliance. "Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application", if you haven't, may be helpful to you in making your argument.