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Software validation templates 

29-Nov-2011 09:16

These are intended to be scalable, i.e. for both very large and very small systems. There is a template for Requirements (high level) and Specifications (how you’re going to meet the Requirement. This is a technical document normally completed by the software people) for larger systems, and a combined Requirements and Specifications for smaller systems. There is also a vendor evaluation form. The vendor’s response to this can be very educational. If you have any questions, please feel free to contact me.

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Attachment(s)
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001 Computer Validation Plan1.doc   173 KB   1 version
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002 Validation Activity Table Excel format1.XLS   25 KB   1 version
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002 Validation Activity Table Word format1.doc   74 KB   1 version
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003 Project Team Action List1.doc   44 KB   1 version
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004 Requirements1.doc   59 KB   1 version
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005 Specifications1.doc   64 KB   1 version
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006 Requirements and Specifications1.doc   72 KB   1 version
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007 Software_Vendor_Evaluation1.pdf   155 KB   1 version
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009 Test Plan Template1.doc   92 KB   1 version
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010 Test Script Template1.doc   64 KB   1 version
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011 Test Results Log Template1.doc   44 KB   1 version
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012 Traceability Matrix Template1.doc   87 KB   1 version
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013 Computer Validation Change Request1.doc   57 KB   1 version
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016 Test Report Template1.doc   76 KB   1 version
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097 Requirements Traceability Matrix (RTM)1.doc   553 KB   1 version
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Comments

29-Nov-2011 16:27

Hi Paula,
Thank you so much for sharing this valuable information. These are certainly a trail of valuable learning and implemention tools for computer system regulatory professionals. I very much appreciate your help!
Utpal

29-Nov-2011 12:02

Paula,
Thanks so much for posting these templates. I am just beginning to investigate options for automating our advertising and promotional review processes. The requirements document looks like an excellent place to start.
Dan Plonski

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