Document Control Features (Document Content Requirements) and 21 CFR 820.40

[JeantheBigone]

Quality system documents typically contain features such as :

Title
Version / Revision number
Effective / Authorization date
Number of pages
etc.

and sometimes contain an expiry date on which the document is to be reviewed for changes / re-approval.

21 CFR 820.40 does not specify this level of detail, nor does ISO 9001;2008 or ISO 13485;2003. The only standard I have seen which explicitly requries specific fields is ISO 15189.

My question is what is the source of these individual fields? Is there a standard that specifies which fields must be included or is it simply good accepted practice?

 

[Pancho]

As you say, there is no requirement for those specific fields in 21 CFR 820.40, nor ISO 9001. So as quality system documents typically contain them, they must assist in fulfilling other requirements in those standards.

ISO 9001 4.2.3e and c, for example, require you to determine the controls needed to identify documents, their changes and their revision status. Seems obvious that having a title, a version or revision number, and effective dates on a document are simple controls that help meet those needs.

21 CFR 820.40 b does require you to save certain information beyond ISO 9001, such as signature of the approving person when a change is made to a document. It does not say that such info need be right on the document, though that is probably a good place for it.

Nevertheless, when you are designing your QMS, be careful not to create busywork. Number of pages is one example of a likely useless field that is indeed fairly common. I guess it may have provided some sort of redundancy check when documents were done by hand, and it became easy to leave on when office software counts the pages for you. But if after considering your particular standard, it doesn't seem like you need a field, then you likely don't. Chuck it.

Good luck!

 

[sagai]

Hello there,
the "source" is likely your former collegues recollection over how to cope with regulatorty requirements.
May be it is more than you would expect to see, may be less.
It is based on their experience, awareness and their level of risk tolerance.

"signatures for document change" is a slippery slope, you should decide wisely what to consider as a change, more importantly what does relate to design change.

So sum it up, if I could have an advise than what you think is the most useful for your company

Cheers!

 

[JeantheBigone]

Thank you for the replies.

To clarify, this is not at my company. I am consulting and performed an audit of document controls for a client. There were document control SOPs and forms that did not have an effective / implementation / authorization date in the header fields. My reaction was to flag it; it certainly is helpful when auditnig to know which forms go with which SOP. Then I found that I was unable to find a specific requirement for it so I feel I don't have a "case.".

The only concern that the client has is that the lack of date field not be flagged by an FDA inspector and their preference is to leave the date off the documents in question. All other documents I've reviewed (for document control as well as others) have a date field in the header.

 

[sagai]

I would look for the intent of the CFR to see if they have any answer for that.
Dates in documents do not necessarily needed, there are plenty of other way to comply with the CFR recently with computerized document management systems. Also there could be manual measures where we do not need date in document.
It could be actually that they are unconsciously complying with the CFR too.
Cheers!