Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.
This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016
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:
Continue reading Evaluating 3rd Party Software Solutions
Hello good people of the world! Today’s post is about qualifying Software as a Service (SaaS), also known as “cloud-based” or “hosted” software. Simply, SaaS is any computer system in which any server is not hosted by the system owner. Here are some key considerations in qualifying SaaS computer systems:
Continue reading Considerations in SaaS Validation
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