Paper-based QMS

S

snoopy2017

#1
If a company stores only soft copies on its controlled server without printing out hard copies (to reduce the amount of paper to be printed), is it still considered a paper-based QMS?
What is the best way to get approvals for such a system? Are digital signatures in compliance with 21 CFR Part 11 sufficient for this paper-based QMS? Thanks!
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
If you only have "soft" (electronic) documents, it isn't a paper based system. What standard are you reading which requires a "paper based" system and where in it does it say a paper based system is required?
 

yodon

Staff member
Super Moderator
#3
Like @Marc said, it really can't be paper-based if you only have soft copies.

As you posted in the 13485 forum, Part 11 may not apply - that's an FDA thing. There are no specific requirements for controls of electronic records (beyond basic document control) or electronic signatures in 13485. There may be country-specific requirements for electronic records / electronic signatures, though.

If you also fall under FDA jurisdiction, these would also be considered electronic records and so the electronic record controls under Part 11 would apply. And if you apply signatures electronically, then compliance to Part 11 for the e-signatures part would be required.
 

John Broomfield

Staff member
Super Moderator
#4
A system comprises interacting parts. Process-based management systems comprise the interactions of processes, people and their beliefs. Processes are the work of machines and humans (and in some cases animals).

Bits of paper (documented procedures) cannot interact and therefore are not systems. These bits of paper may however partially describe the system of interacting processes, people and their shared beliefs. Much of the system comprises undocumented procedures that effectively control our processes.

Computers and software may deliver electronic versions of the management system including some automated process controls. These systems are evolving to eliminate the paper and to assign more work to machines.

It is therefore more helpful to think in terms of a documented system than a system of documents.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Much of the system comprises undocumented procedures
A bit :topic: but - Good point. Many people miss this aspect which is why so many companies "over document", and over the years has been complained about how many standards have a burdensome requirement for documents.
 

JoshuaFroud

Involved In Discussions
#6
Hi Bookish,

Question, are the documents maintained within a specific piece of Document Management Software, or are they freely accessible files that are unprotected such as Microsoft Word?

If nothing is printed and everything is maintained as soft copies then it is not a paper-based QMS (at least not in its entirety).

The QMS I'm currently managing is split between paper-based and digital. We have our procedures, work instructions and forms as digital documents within a piece of document management software (designed for that purpose, that has a built-in digital signature approval route) but forms and batch records are completed to be filled in by hand. The digital sections of the system are assessed as a digital system and anything printed is handled as such.
 
S

snoopy2017

#7
Thanks for all your helpful responses. The split paper-based and electronic QMS sounds doable.

1. Maintain documents like SOPs and work instructions on a controlled server, and use DocuSign for e-signatures.
2. Manufacturing Records, are filled in by hand.

Without using any electronic Document Management Software, if we keep all QMS documents on a controlled server using electronic signatures, this is still considered an electronic QMS? I believe the electronic compliance is an FDA requirement; if we are under ISO, is the electronic signature not required?
 
S

snoopy2017

#9
If all the QMS documents are kept on a controlled server in an electronic QMS, what QMS software needs to be validated? Since we are not using any particular document management software, does that mean we don't have to validate anything?
 

yodon

Staff member
Super Moderator
#10
Without using any electronic Document Management Software, if we keep all QMS documents on a controlled server using electronic signatures, this is still considered an electronic QMS? I believe the electronic compliance is an FDA requirement; if we are under ISO, is the electronic signature not required?
First off, there's no defined entity of an electronic QMS. There is a QMS and you may choose to manage it as electronic documents and records. There are no FDA requirements for managing a QMS electronically; however, if you do, then the documents and records you manage electronically fall under Part 11.

As @John Broomfield pointed out, approval is required. You may choose to approve documents through electronic means (e-signature, biometrics). You can manually apply signatures, scan the documents, and still enable access electronically.

If all the QMS documents are kept on a controlled server in an electronic QMS, what QMS software needs to be validated? Since we are not using any particular document management software, does that mean we don't have to validate anything?
Right, if you're not using software, there may not be specific software validation actions required. However, if Part 11 applies, you would want to qualify the system to demonstrate compliance (e.g., system access, protection, etc.). And even if you're not using an electronic document management system, you still probably have backup software that would come into play (since it's likely that's part of the 'protection' considerations).
 
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