Validation Records - Very young QMS

Steven Severt

Starting to get Involved
#1
I've been doing some work on a very young QMS for a medical device manufacturer. Right now the goal is strictly 21 CFR 820 compliance, but ISO 13485 certification is part of the small company's future aspirations. We are doing our first 510(k) and filing away the validation reports. I have a controlled validation report form from a template package that we are using. We are summarizing the reports, intended use, conclusions, etc. on the form and filing it in the DHR, but should I also control this document with some record number? Is it enough to title it and file it in the DHR, or do these types of records have to be controlled with document numbers and such?
 
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yodon

Staff member
Super Moderator
#3
There's nothing that says how / what you have to number. Everything needs to be uniquely identifiable and readily retrievable. A title is likely insufficient to ensure uniqueness. A title and a date might.

Do think big picture first. You'll have multiple V&V documents / records so map out your strategy on how to ensure uniqueness and how you will be able to find any document / record when asked.

If 13485 is your longer term goal then you can start now by driving towards compliance there. It's not a big leap from 820. The investment now will save time in the future, avoiding gap analyses, remediation efforts, etc.
 
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