CAPAtrak Blog

Diane Kulisek's Comments on Quality

Quality Resource – Product Validation Protocol Template (MS Word)

Posted by Diane Kulisek on October 5, 2009

ProdValProtIf you’re in a hurry, you can click on the image to the left to request this post’s Quality Resource, the Product Validation Protocol Template/Example in MS Word. 
I realized, as I was getting ready to transfer my work to a new computer, that I have developed, over the years, many, many types of quality assurance tools, templates and examples that I could share.  The tools I’ve developed are typically in MS Word, MS Excel, MS Access, MS PowerPoint, Adobe .pdf and a smattering of other formats. 
This will be the first such item I make available through my BLOG.  There are some standing downloads always available on the CAPAtrak website, as well.

To get to the Quality Resources I’ll be sharing with my BLOG readers, I ask that you please use a Special Request Form.   Pardon the advertisements, please.  The form was able to be created, free to me, via Bravenet.com and I cannot currently justify the expense of subscribing to the form without them making their money via ads.

The good news is, if you use the form just once, you can save the final link to your favorites and just check back at that same URL when you see me mention a new resource here.  You could share the direct link with your friends, as well, but I hope you’ll afford me the courtesy of asking them to please use the form, as well. 

By using the request form, I’ll know who cared enough to use my stuff… and I can keep those who do alerted to other new stuff from time to time.  Just so you know, I’m not exactly sure how to do that, yet.  I’m not going to load your inbox up with solicitations, that’s for sure. 

Anyway, let’s talk about this particular resource.  As I began working in FDA-regulated companies, I realized that there was a need to structure the means by which new or changed products were ‘validated’.  Just so we’re clear, ‘validation’ means checking to be sure what you’ve got is appropriate for an intended use.  Validation is typically structured against the Product Specification, which will be used to drive labelling and product performance claims.  There are many ways to approach validation and each is uniquely tailored to a specific need… but I thought you might like to see a somewhat standard and simple format for a product validation protocol that has worked for me.  Feel free to use it as a template for your own validation efforts.

If this particular validation approach doesn’t seem to resonate well with your specific needs, try searching Google for others.  I got 474 MS Word document  hits when I entered this search string:  “validation protocol” filetype:doc .

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.

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One Response to “Quality Resource – Product Validation Protocol Template (MS Word)”

  1. [...] Quality Resource – Product Validation Protocol Template (MS Word … [...]

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