Hello good people of the world! This blog post covers Construction Quality Assurance, based on an article that appeared in the Nov/Dec 2012 edition of Pharmaceutical Engineering titled “Assured Construction Quality Saves Time and Money.” All credit goes to the authors: Jay Lad of Skanska Pharmaceutical Group and Bruce Beck of Eli Lilly. Continue reading Quality During Construction
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:
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:
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:
Mike Williamson Validation 