Microsoft Sharepoint as Document Control Software - FDA Validation Requirements

[MIREGMGR]

Microsoft Sharepoint is sometimes used as a starting point for FDA QSR document control systems.

The temptation exists to regard validation of Off The Shelf (OTS) software as too big a project, and not worth the effort because it must work or its seller wouldn't offer it.

The FDA issued a Warning Letter on 29MAY2009 pertaining, among other things, to failure to validate Microsoft Sharepoint in a document control application.

 

[rclanzillotto]

Re: Sharepoint as document control software

In that vein, lets start a discussion of a typical validation program for OTS software like this. I think prior history is a part of a validation file but supplemented by formal functional testing in the dedicated server environment. What else?

 

[yodon]

Re: Sharepoint as document control software

Well, before you can start functional testing, you need to define your user requirements. This would include roles, security, etc. We then do a risk assessment to better scope testing. This would allow us, for example, to minimize security testing if security is justifiably not a risk.

We will also try to get a bug list from the vendor and analyze the known bugs to determine if there would be any adverse effects in our environment.

 

[rclanzillotto]

Re: Sharepoint as document control software

We then do a risk assessment to better scope testing.

We will also try to get a bug list from the vendor and analyze the known bugs to determine if there would be any adverse effects in our environment.

Thank you..great comments! I would never of thought about the bug list request.

 

[shan_amudha]

Hi ,

Can anyone let me know what are the control points for validating Sharpoint in a regulated environment. I am doing an IQ/OQ/PQ for Sharepoint and would like to know in detail as to how we do it.

 

[kimovitch]

Hi ,

Can anyone let me know what are the control points for validating Sharpoint in a regulated environment. I am doing an IQ/OQ/PQ for Sharepoint and would like to know in detail as to how we do it.

Hello, I'm on the edge of starting to validate a sharepoint system. Even more complicated as it will be the online version of sharepoint provided by Microsoft. Anyone completed the task and reached a formal validation report?

 

[harry]

I am not sure if these links are useful:

Microsoft.VisualStudio.SharePoint.Validation Namespace

Google links

 

[kimovitch]

Maybe it is but I don't know how to use that.

I think I will follow GAMP 5 recommandations

 

[harry]

Maybe it is but I don't know how to use that.

I think I will follow GAMP 5 recommandations

I'm sorry for not being able to help you further. I am sure others will chime in later (week-ends are usually quiet)

 

[harry]

Try this recorded webinair

This set of slides is available for download.