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:
- Sharepoint configuration guidance for Part 11 which was released earlier this year.
- The Update Impact Analyzer (part of the Application Compatibility Toolkit) and how it can be used to reduce the amount of patch validation that an organization has to do (and the subject of a forthcoming MSDN article). This tool was developed with the (significant) input of a major pharmaceutical company.
- Validated products, such as our ERP product for the Life Sciences industry (Microsoft Dynamics AX for Life Sciences)
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.