Digital DMF (Device Master File) Records

rob73

looking for answers
#1
I've been considering for a while converting our DMF to digital format, I have in the past created a simple HMTL driven file with links to the relevant documents. It would cut down on duplication of documents and save paper, but would it be worth the hassle as i'm guessing each DMF would need some sort of validation.
Any thoughts??
 
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SteveK

Trusted Information Resource
#2
Re: digital DMF

Hi Rob,

I do not have DMFs (I assume for class III devices), just Technical Files (TF) for our Class IIa & IIb products. All these are retained on file as pdfs which I can update with Adobe Acrobat (had to scan in certain documents). They have internal hyperlinks for navigating around the document (plus some external links to e.g. a device alert reference). These are what I submit to our NB – in fact that is the format that they expect to get our TFs for review. I did originally produce paper copies, but these are no longer updated to save on trees. Not sure how you would validate any of this or in fact need to.

Steve
 

RobertvanBoxtel

Involved In Discussions
#3
Electronic DMF are in the current days the most effective way to identify the relevant documents.
But, keep in mind, any software used in quality related matters will have to be assessed on risks and where relevant needs to be validated (new ISO 13485 requirements). And when changes are made to location of documents, can you ensure that all hyperlinks are still maintained? I am not saying that paper is better, just that there are other challenges to control.
 

rob73

looking for answers
#4
That's what i thought, although i suppose validation could be as simple(!?) as printing off the code and signing off on all of the links.
Food for thought.
 
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