Hello good people of the world! This post is about evaluating 3rd party software solutions for GMP use and is based on this excellent questionnaire from the Canada-based company Montrium: 17 Must-Ask Questions for Demonstrations of Regulated EDMS’
The following are some topics to focus on:
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Hello good people of the world! Today’s post is about implementing and using Microsoft SharePoint 2013 in a regulated (GMP) environment.
Microsoft has published a comprehensive guide to SharePoint 21CFR11 compliance, which can be downloaded for free here.
Basic software requirements are:
Continue reading SharePoint 2013 in a GMP Environment
Validation, Qualification, and Commissioning For Pharma, Biotech, and Med Device Industries