Signatures for Documents and Records

[sagai]

Hi World,
have an open question to see other's recollection of signatures on documents and records for the spirit of 21CFR820.

When I am looking into Sec. 820.40, it is explicitly saying (at least for me) that:
- all approval on documents needs to be signed by individual,
- all change records of such documents need to be signed by individual,
- and nevertheless it is for all documents required by 21CFR820.

So for me it is literately means that where ever I see "shall be documented" than the 820.40 applies.

Question1!
Is it the case or I am utterly misunderstood something?

Qestion2!
What about records? When we see in 21CFR820 saying records needed, does the 820.40 applies?

More of my never ending questions ...

Question3 is coming ...
The things are going into further confusion and debates when I have a read of:
- 820.30(b) whereas it is saying

The plans shall be reviewed, updated, and approved as design and development evolves.

So, how far we can go with it?
Does it means that it is not subject to 820.40 only these explicit controls in the section itself?

Question4 ...
and the most confusing stuff I have encountered is when we have a read of 820.30(c) and (d).
"The approval, including the date and signature of the individual(s) approving ..., shall be documented."
Why is that? Does the 820.40 is not enough on it is own?
Or ... do we actually only need to sign these two kind of documents?

I would truly interested in your opinion.

Many thank.
Regards

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[MIREGMGR]

In our operations, someone signs almost everything. Production, shipping and receiving people sign their records. Lab techs sign their records. Quality people sign their records. We have a signoff system for designers and engineers. The sales manager signs new product charters. Either I or the Quality Manager sign all memos to file, procedures and so forth. A manager signs all work instructions. Work order travelers get a number of signatures. Minor product design/documentation corrections get one signature plus one for implementation, significant changes get six signatures before the change and two indicating implementation.

Maybe our system is overkill, maybe not. None of the parties that inspect/audit us have challenged us for inadequate implementation of the spirit of 21CFR820, which is proof of control, and similar rules under other regulatory systems, and we want to keep it that way.

 

[Chrisx]

This question recently came up in my company. With some QMS software we recently purchased, it would be advantageous to reduce the number of records that have signatures. My thought at the time was that anywhere ISO 13485 requires approval or authorization, then their should be a signature. This isn't a clear requirement in the standard, but makes sense to me.

Doing search thru 21CFR820, there appears to be more locations where a signature is required, then you cited. Besides 820.40, 820.30 Design controls, 820.75 process validation, 820.80 acceptance activites, 820.90 nonconforming product, 820.120 Device labelling.

Between ISO 13485 and 21CFR820, it did not appear we could reduce the signatures on records much at all in our organization.

 

[sagai]

Well, I am more or less confident about that ISO13485 does not mandate any signatures.

Let me have than the a question.
So for Records, what is the regulatory requirement to keep signatures on records than?
Many thanks.
Regards

 

[ariannas]

Hi sagai --

We wrestled with this and ultimatly our organization went down the same road as MIREGMGR's did -- we sign practically everything, although our specific process is somewhat different because we are very small.

When I combed through 21 CFR 820, my conclusion is that since 95% of what it mentions has to be approved and/or signed, it was best just to sign everything rather than have debates over what 5% doesn't need to be signed. Again - we are a small company, so this approach might not work for everyone.

Side note: the nunber of signers varies based on the nature of the record. For example, an acceptance record for a very low risk outside component would have only a single signature. But the overall testing summary record that covers all testing for a product has several signatures.

HTH,
Arianna

 

[maaquilino]

Well, I am more or less confident about that ISO13485 does not mandate any signatures.

Let me have than the a question.
So for Records, what is the regulatory requirement to keep signatures on records than?
Many thanks.
Regards

ISO 13485 states in a number of areas that documents need to be approved. Approval generally takes the form of signatures, and approvals need to be documented. A company's document control procedure should state how approvals are done. The regulations a company must follow state what records must have approvals.

Comparison of ISO 9001, ISO 13485, and CFR820:
See the document at: http://www.compliance-alliance.com/wp-content/uploads/2010/05/Kimmelman-Chart.pdf

You can do a search on the above document on 'approve' to see the sections it applies to. For example, in section 7.3.3 of ISO 13485, it states design outputs must be approved; design outputs are a record.

 

[kgott]

Well, I'm going to disagree. Unless the standard says that xyz documents must be signed by a person of abc status and importance, signing a procedural type document achieves little or nothing.

What is of greater importance is that the document is approved for use in the business by the organisational leadership. This can be achieved simply by leadership saying in a email or a meeting minute that xyz document is approved for use.

Signing documents does not confer commitment, it does make the contents known and understood by those whose job is to comply with the requirements of the document and it does not make or ensure its implemented.

Signing documents is rampant in safety and many people seem to think that in some way it conveys managements commitment to the contents of the document. I for one don't.

Many QA and safety managers are keen on signing bits of paper simply because it makes them feel powerful, it enables them to enhance their status and importance in the organisation and attain influence and pay rates their position would not otherwise attract.

Signing bits of paper in a business is always attractive to control freaks.

 

[MIREGMGR]

Posts above refer to ISO 13485, but this forum-section nominally pertains to 21CFR 820, and therefore USA law. FDA under USA law has clear expectations in a number of areas, revealed in guidances and inspection reports, that records and sometimes procedures and other documents must be signed by an authorized individual. Signatures have particular significance in USA law.

 

[Mark Meer]

(Slightly off topic rant...)

Signatures have particular significance in USA law.

While I understand the state of affairs is as MIREGMGR puts it, practically speaking I tend to agree with kgott's post.

Traditional pen-and-ink signatures add little value to a Quality System these days. In fact it is often a burden to have to circulate documents for signatures.
In my opinion, US law's signature obsession is an dusty relic.

What benefit do pen-and-paper signatures and dates add when:

• people are signing so much stuff they can't recall at a later date whether they signed something specific or not.
• people's signatures can vary tremendously, making it hard to attest if a particular signature is indeed by your hand (don't even get me started on the digital pads used by courier services these days..)
• documents are often scanned, making forgery a cinch (if you we so inclined)
• any pen-and-paper dates can be easily back-dated or pre-dated

And more on topic...

I've mentioned it before, but we had an FDA inspection where the inspector wrote a 483 because we were not signing management reviews (we were only listing the attendees). Now we have to print and circulate the minutes and obtain dated signatures as "proof" of attendance.

...but this goes to show that the FDA has a particular thing for signatures (even if the value is questionable). ...so when in doubt, sign.