Are you looking to validate Microsoft SharePoint for Regulated GxP Applications?

Our validation accelerator pack can significantly speed up the validation process. Request samples today!

Montrium has qualification packs for 2010 and 2013 versions of SharePoint. These qualification packs focus on identifying the technical controls within SharePoint functionality that can be used to meet 21 CFR Part 11 requirements and the procedural controls that need to be in place. Our documents enable you to clearly document these controls and test them to ensure that they have been configured correctly. 

Montrium's SharePoint Qualification Pack contains:

  1. Validation Plan
  2. Requirements Specifications
  3. Validation Assessment
  4. Functional Specification
  5. Configuration Specification
  6. IQ Protocol and Test Scripts
  7. OQ Protocol and Test Scripts
  8. Traceability Matrix
  9. Validation Summary Report
  10. Deployment Guide

We will send you samples of:

  • SharePoint Qualification Pack Overview
  • SharePoint Qualification Plan
  • Regulatory Impact Assessment
  • IQ Test Scripts
  • OQ Test Scripts
  • SharePoint Trace Matrix

Use Montrium's SharePoint Qualification Pack to structure your validation approach to meet the requirements of 21 CFR Part 11 electronic records, while also minimizing the scope of the validation process.