Montrium has engineered a Validation Pack, documents that are part of our Validation Toolkit
for Microsoft's flagship GxP content management application, SharePoint Online.
This Pack focuses on identifying the technical controls within SharePoint Online functionality that can be used to meet 21 CFR Part 11 & Annex 11 requirements and the procedural controls that need to be in place. The contents enable you to clearly document these controls and test them to ensure that they have been configured correctly.
Montrium's SharePoint Validation Pack contains:
- Validation Plan
- Requirements Specifications
- Validation Assessment
- Functional Specification
- Configuration Specification
- IQ Protocol and Test Scripts
- OQ Protocol and Test Scripts
- Traceability Matrix
- Validation Summary Report
- Deployment Guide
Montrium's SharePoint Validation Toolkit is designed to structure your validation approach to meet the requirements of 21 CFR Part 11 & Annex 11 electronic records, while also minimizing the scope of the validation process.