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Showing Evidence of Review and Approval of Blank Forms and Templates

Sue789

Involved In Discussions
#1
I am working for a small medical device design and manufacturer and we are a paper based company to ISO 13485 and supply the US.

What would you recommend is the best practice on how I could show that the forms and templates have been reviewed and approved?

I do not wish to control the changes via the SOP any ideas and examples welcome.

Thanks in advance.
Sue
 
Q

Quality_Steve

#2
Re: Review and Approval of Blank forms and Templates

I am working for a small medical device design and manufacturer and we are a paper based company to ISO 13485 and supply the US.
Welcome to the Cove,

To get a feel for your process, may I ask who prints the forms/templates? If printed externally, then what do they use for an original proof? If printed in-house, where is it printed from, a hard drive perhaps? Or maybe one might make copies of copies until the copy becomes unreadable and then what? :confused:

Basically what I'm saying is a proof used by your favorite printer can be controlled and a file on a hard drive can also be write protected to eliminate unauthorized changes. If your company is using the copies of copies then I don't really know what to say.

The review and approval of the forms can be another simple form stating the name of the form/template and what was changed with a signature of someone with the authority to authorize the change.

We put the revision letter and release date along with the control number on our forms but I know there are many different ways to get it right.

You may also want to check out some of the other posts on document control.

Good Luck,
Steve
 

yodon

Staff member
Super Moderator
#3
Re: Review and Approval of Blank forms and Templates

Sue,

First off, check your internal SOPs (esp. doc control) to ensure that whatever you do, you'll be compliant.

One of my biggest peeves is the draconian control of forms. Some forms, like MDRs do need to be well controlled since there's so much required information. Others, like training forms, should be malleable to allow you to capture information as needed. That's just my opinion and would likely only work for small shops, as you indicate you are (it's what we do and we're also a small shop and also registered to 13485).

One of the things we've done to allow some flexibility is to snapshot the form in a WI and say that the copy in the snapshot OR SIMILAR can be used. When there is required information, we identify it (so it doesn't get tailored out - don't want too much flexibility!).

We also have a controlled area where forms are kept. If a form goes in there (through the controlled process / via restricted access), by default it has been reviewed and approved. Our procedures describe that process (along with the access restrictions). It's a read-only copy and people can pull a soft copy, fill it in, and print it.

I probably wouldn't recommend this for a larger shop but it works for us and it's been defensible to our registrar. We don't do manufacturing so we haven't been audited by the FDA.

The point is to think about what controls you really need, ensure your procedures are set up to define those controls, and the infrastructure is built to implement those controls.
 
#4
Re: Review and Approval of Blank forms and Templates

Simple answer is to use a Document Control Request and have that be the vehicle for all reasons for documents, approvals, changes and subsequent removal from the system. It can be the whole lifecycle and doesn't require that stuff to be kept 'in' the document. Trust me, it works well!
 
S

ssz102

#5
Re: Review and Approval of Blank forms and Templates

i agree with the above said

you can add review requirements on the Documents Control Procedure
 

Sue789

Involved In Discussions
#6
Thank you very much for your replies.

It has been several years since I have been involved in QMS documentation and my last Company was a large multinational and documents were all reviewed electronically (21 CFR 11 compliant).
I am working with a company of 13 staff whose QMS is approved to ISO 13485 and now updating the QMS for FDA 21 CFR 820 requirements.
Steve, all documents are controlled via visual source safe and are internally generated.
Andy, I had forgotten about the Doc Control Request form thanks for the reminder and this is the way I am going to go.
Sue:D
 
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