Addressing wet ink signatures when more than one site is involved

JoshuaFroud

Involved In Discussions
#1
Hi All

First post here after lurking for a number of years. I have recently moved to a new job at a much smaller and less mature company and I am currently the only Quality Professional, due to this being asked a lot of "can we...." questions.

Today's question I have not been able to answer as its not a situation I have come across before.

The situation is; recently some management has been transferred to a site in a different country (Site 2) with the majority of the working staff at the original site (Site 1). This has caused some problems with the signing and authorization of documents requiring a signature.

The current practice is to fill in and print the document at Site 1, scan this and email to Site 2 for them to print, sign and scan back. The document with two signatures on is then printed and put on file. This leaves three copies of the document in existence, none of which actually have two wet signatures on and the copy on file has none.

I am unsure if this is truly compliant with any of the relevant regulations (9001, 13485, CFR 820) we fall under. Can I please ask for comment?


In addition, for those of you that work in a similar situation how do you address this issue?

Thanks!
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Is there a specific reason why you are requiring "wet" signatures in this day and age?

The only requirement(s) for "wet" signatures that I am aware of are in a few law and banking related documents in some countries (most are related to corporate transactions such as some contracts). Most countries are pushing the EU legislative framework (the Directive on a Framework for Electronic Signatures (99/93/EC)) implemented into UK law under the Electronic Communications Act 2000 (ECA) and the Electronic Signatures Regulations 2002 (SI 2002/318).

Your system sounds overly complex and somewhat dated. I would consider moving to electronic approvals.
 

JoshuaFroud

Involved In Discussions
#3
I completely agree with all of your points, the problem is we have moved from a single site to multiple sites almost overnight and the systems have not kept up.

When all signatories for a document were based within 10m radius signing the documents by hand was the most cost effective means considering the number of employees and number of documents needing authorisations.

I guess I'll be looking to find a way to justify an e-signature system then!
 

BradM

Staff member
Admin
#4
I would strongly recommend that you look into getting e-signatures.

The current system you have, minimally you will need to have a procedure to define control of those documents. The problem is... which document is the original?

I would suggest purchasing a compliant electronic signature system; maybe one that works with Adobe. Make sure it meets the CFR requirements; so you don't exchange one headache for another one.
 

Chris Ford

Quite Involved in Discussions
#5
Don't feel bad. I think I've posted something twice in 10 years! Well maybe a few more, but it's rare.

FYI, there is no requirement anywhere that you have a wet signature on your documentation. Scans, including fax and photo copies are legally binding.
 

Chris Ford

Quite Involved in Discussions
#6
I completely agree with all of your points, the problem is we have moved from a single site to multiple sites almost overnight and the systems have not kept up.

When all signatories for a document were based within 10m radius signing the documents by hand was the most cost effective means considering the number of employees and number of documents needing authorisations.

I guess I'll be looking to find a way to justify an e-signature system then!
What you are currently doing is fine. You just need to be sure that you identify a signed copy as the "master." (and that does not require a wet signature)

Just because a technology exists, doesn't mean you need it. In order to utilize electronic signatures, you'll need a complete Part 11 validation for both signatures and records. You'll need infrastructure to maintain the signatures, and store electronic copies of the documents you approve. Then at that point, why even maintain a paper system at all?

You can maintain a complete set of controlled, stamped paper documents for those without access to the PDF or make printed copies valid for 24 hours from the date printed.

You could save some money on paper and storage by switching to electronic, but setting it all up is costly and ripples through your entire quality system. If you're not creating a lot of paper, there is little reason to consider switching yet.

The issue you raised was whether or not your document controls are adequate and compliant without wet signatures. Someone raised a point that with all of the copies floating around, how can you ensure the accuracy of the document?

I'd recommend that you make sure your document control procedures adequately address the identification of documentation and status of documents (ie. using a stamp on the Master), and I'd follow these steps:

Fill out and print and scan the document
Send the scan to site 2
Destroy the paper print-out
Site 2 prints, signs and scans approved document
Site 2 destroys printed copy
Site 1 receives approved document, prints it, then stamps it with "Master" or "Original" then completes the change process.

And... that won't cost you anything.

Hope that helps!
 

Ninja

Looking for Reality
Trusted Information Resource
#7
I would take a pause...and determine what the signature actually MEANS...and whether it is necessary at all.

"Approval" can take many, many forms...signature is only one of those forms.
Now that you're in two distant sites...perhaps one of the other forms will serve you better?

Single signature with email approval from party#2.
Single signature by trusted officer, trusted that he got approval from person #2
e-sign
Database restricted privilege check-box

Unless the actual signature image itself has value...you have many, many choices to choose from to streamline the process.
 

Chris Ford

Quite Involved in Discussions
#8
I didn't ask, so I apologize that I'm assuming you're a registered US manufacturer. This advice applies to FDA jurisdiction, and is in response to one of the last comments I read which suggested that an actual signature is not required and you might want to consider alternate indications of approval. This is incorrect, and there are no other methods to demonstrate approval other than a signature. A signature can take several forms.

Approval signatures are, in fact required for documents and changes. The quality system regulation places specific requirements for the "signature" of a person in only nine sections of the regulation, including document controls (820.40). In addition, the QSR emphasizes in three sections the requirement that records must be approved in accordance with 820.40 (document controls). And in one unique part, FDA requires only the name of the individual making the decision to investigate a complaint or not.

Seemingly, we assume that the lack of a requirement for a signature on a record requirement means that no signature is actually required. But if FDA only requires signatures on 12 records, why do manufacturers create bureaucratic approval requirements throughout the entire QMS? We know there are many more than 12 records of activities required by FDA, so why don't we have to sign them all? The fact is, we do need to sign them.

That's why it's so important to understand exactly what FDA requires, and the purpose of 820.186.

Rather than repeat a records requirement for every record mentioned in the regulation, FDA includes 820.186 Quality System Record. This requirement, due to its ambiguity, has baffled industry since the QSR was published. However, this long-standing mystery section is really just saying, "this is the general requirement for all records, including those that we don't show to FDA (management review, audit reports, supplier audits, etc.).

820.186 states:

"Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40."
Simply put, FDA is saying that, unless otherwise stated in the REGULATION, ALL records required by the manufacturer's Quality Management System that are not specific to a device shall be prepared and approved in accordance with 820.40, which means a signature is required. FDA further clarifies that while it will not review management review data, and internal and supplier audits, it emphasizes that manufacturers are expected to maintain them in accordance with these requirements. Manufacturers are expected to provide evidence that they meet these requirements in procedures, log files, or certification.

A signature is explicitly required for:

  • 820.30(c) design input
  • 820.30(d) design output
  • 820.40(a) document approval
  • 820.40(b) document changes
  • 820.75(a) process validation
  • 820.80(d)(3) final acceptance records - the release is authorized by the signature of a designated individual(s)
  • 820.80(e)(4) inspection records
  • 820.90(b) non-conforming product - signature of person authorizing use of product
  • 820.120(b) labeling review and release

The following are required to be approved in accordance with 820.40 (signature required) - in other words, the regulation does not specifically state, "signature of the person" is required, but it does specify that these be approved in accordance with document controls, which requires the signature.

  • 820.50(b) purchasing data
  • 820.70(b) production and process changes
  • 820.191 Device Master Record

The name of the individual responsible is required for:

  • 820.198(b) complaint evaluation - requires the name of the individual making the decision to investigate or not.

Since 820.40 requires that approval be executed by applying a signature, you're left to consider your options for how the signature will be manifested - electronic signature options, wet signature, etc.

It doesn't sound like your company is overwhelmed with the number of approvers (you only mentioned 2), but I often find that top management is responsible for review and approval of a lot more than it should be.
 

Chris Ford

Quite Involved in Discussions
#9
One last thought... I forgot to clarify the meaning of the requirement:

The QSR shall include, or refer to the location of, procedures and the documentation of activities...
The documentation, including records required in the quality system should be documented in your quality manual, if it's a 13485 system. In the extremely rare situation where a FDA investigator asks to see the "quality system record" your 13485 quality manual will fulfill this requirement. If you haven't implemented 13485 on your QMS, you should have another form of a quality plan in place that outlines the required documents and records in your QMS.
 
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