Validation and the Microsoft Platform


As part of our work with Medical Device companies (as well as with pharma and biotech companies) we’ve been looking at the issue of validation and how it impacts Microsoft products.  This is not a new topic: we’ve been working on validation and regulatory issues for awhile:

Of course, those are just three brief examples – there are many more. 

But, here’s the thing: I need your help.

I’m in the internal review stages of a document that details Microsoft’s development methodology and maps that methodology into the industry “v-model”, and would like the input of knowledgeable people from the life sciences industry who understand the v-model and validation.

The questions I am trying to answer:

  • How will the white paper be useful to your company?
  • Does it describe the v-model appropriately?

Of course, other comments are appreciated. 

If you are interested in reviewing the document, please comment to this post and I will contact you directly.

Comments (4)

  1. Tony Smith (tsmith@datalan.com) says:

    I work for DataLan Corporation, a Microsoft Gold Partner.  I would like a copy of the “Validation and the Microsoft Platform” white paper.  I work with several pharmas where we are introducing SharePoint 2007.

    Thanks

  2. LJrdn says:

    Excellent!  I will send it along.  You can also find the Sharepoint configuration guidance for 21 CFR Part 11 on the MSDN site as well.

    http://msdn.microsoft.com/architecture/lifesciences

  3. Eric Swenson says:

    RS Medical markets electrotherapy devices. V-model is a methodology we are looking at, but its relative obscurity left me wondering how it could/should fit with MSF. If you would like feedback from less seasoned (but no less interested) people, I would be happy to have a few review it here.

    eswenson AT rsmedical DOT com

  4. Richard Love says:

    I am very impressed with your approach.

    Could I please get a copy of your whitepaper “Validation and the Microsoft Platform” ?

    Thank you,

    Richard Love

    Exec Dir., Global Technical Operations

    Stiefel Laboratories

    richard.love@stiefel.com

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