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Microsoft Sharepoint as Document Control Software - FDA Validation Requirements

M

MIREGMGR

#1
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.
 
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R

rclanzillotto

#2
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

Staff member
Super Moderator
#3
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.
 
R

rclanzillotto

#4
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.
 
S

shan_amudha

#5
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.
 
K

kimovitch

#6
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?
 
K

kimovitch

#8
Maybe it is but I don't know how to use that.

I think I will follow GAMP 5 recommandations
 
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