Resources
The FDA’s new approach, Computer Software Assurance (CSA), represents a significant paradigm shift and places critical thinking at the centre....
1. Jean E. Sammet – The Creator of the First Widely Used Programming Language Jean E. Sammet graduated with an....
By Eddie Ryan, Chief Executive Officer, Kneat Solutions | First published on learnaboutgmp.com Companies operating in the life science industry....
Regulatory expectations related to GxP validation have increased in both inspection focus and in complexity. And it doesn’t get any....
In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are....
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes....
It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This....