Tag Archives: Computer Systems Validation

WHO’s Draft Guidelines on Validation May 2016

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

Can SharePoint Online be Compliant?

Microsoft_SharePoint_2010_Foundation

SharePoint is an off-the-shelf configurable software solution that has been offered by Microsoft since 2001. It is popular in many industries (including Biotech, Pharmaceutical, and Medical Device) for document management, local Intranet, and many other applications. However, if SharePoint is being used for any GxP purpose, you better believe it is subject to 21CFR11 and/or Annex 11. Continue reading Can SharePoint Online be Compliant?

Evaluating 3rd Party Software Solutions

Software Solutions

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

Considerations in SaaS Validation

SaaS Qualification

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

SharePoint 2013 in a GMP Environment

SharePoint

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