Hello,
In a rather small company I work for there is a form that needs to be approved or authorized by the Quality Director and the Managing Director for the obsoletion of controlled documents. We are also using a protected excel sheet where the obsoletion of these controlled documents is tracked.
Is it necessary by GLP regulations/guidelines/etc to have such an obsoletion form as we use now. Or can we suffice with the excelsheet if validated / etc.
Erik
Yes (see 21 CFR 210 1nd 211?). By using such a form you demonstrate control of your forms and process.
@Boomer_Chemist - can you point to specific clauses in 210 and/or 211 that require a form to obsolete documents?
I’m most familiar with the device side and there’s nothing in 820 that requires a form to obsolete a document. You just have to maintain control and be able to identify current / obsolete. (If you choose to do that by a form or spreadsheet, maybe that’s ok).
The creation, modification, or deletion of any controlled document, must be done per procedure, and by the right person, and recorded using their personal signature or identification. In basic terms, a person’s signature is not to be forged, and a persons e-signature is also not to be forged.Typically, this is accomplished via hard copy (paper signature) but may also be done via electronic signature. For electronic signature, this is done by ensuring that there is a password for each person signing, and that the password is controlled and secure. (there are other requirements for e-signature and CFR compliance, but this is the highest level I can give you relating to your question)
Here is a guideance from the FDA (I did a search for “e-signature” in google).
FYI. There are programs or code which you can buy which allow excel to record e-signature. For a small company, the e-signature might be more costly to set-up and maintain than just keeping paper trails. You just need to be able to respond to an audit to quickly show the document history at a moment’s notice - it is much easier with electronic systems. I may be missing something, though. It might be required to keep documents electronically now. I know a company must be able to show the history of a document through its many revisions.
@JaredCroft - what you say is accurate - if you apply a signature electronically to a document that requires signature by regulation (“predicate rule”) then 21 CFR Part 11 does, indeed, apply. But I think it’s deviating from the question raised in the original post.
The original question was whether or not a form (with signatures) is required to control obsolescence of a document.
In the device world (21 CFR 820, et al.), I don’t know of any such requirement. The procedures described in the original post may be above and beyond what’s required by regulation (which often results in unnecessary bureaucracy).
That really surprises me that the obsoletion of a controlled document would not require some sort of sign off (either electronic or hard copy). Of course the majority of my experience is in pharma/biotech. But still, a quality system is a quality system (I expect). Please if this is not the case, post the reference here as I’m always looking to expand my experience. Thanks, Jared
Again, speaking from the device side, there’s no such requirement (21 CFR 820). The only mention of obsolete documents is that “obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use” (820.40(a)).
ISO 13485 takes a similar tack, stating that control of documents (includes): “to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.”
So that’s why I was asking what standard / regulation requires signature (or form or specific method) to obsolete a document.
Is there a specific requirement? No. There is also no specific requirement that you maintain a signature log, or that you use blue indelible ink (or at least black), but hopefully you do both of these.
When you obsolete a controlled document it has a ripple effect. It may be being used elsewhere or be referenced in other documents leaving a hanging audit trail. Therefore it is important to have a system to approve the obsoleting of controlled documents, which should include checking references or links to other documents and checking with department managers to ensure they aren’t being used. So, yes, it’s likely a form with some sort of sign off is required as evidence that someone has checked those things (does everyone do that…no).
I’m also intrigued by the mention of the validation of the excel log. If it is simply a log of obsoleted documents, exactly what are you validating? The evidence is the signed forms, the log is simply an organizational tool.