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Lean validation in GxP organizations
Becoming known as the ‘Toyota Production System, this ‘Just in Time’ approach to inventory management provided inventory per production demand.
How Kneat’s SaaS platform is empowering customers through COVID-19
COVID-19 has become a stark reminder of the threat pandemics pose to the continuity of critical industries and the vital....
What is computer software assurance (CSA) and why is the FDA transitioning from traditional computer system validation?
The FDA’s new approach, Computer Software Assurance (CSA), represents a significant paradigm shift and places critical thinking at the centre....
10 trailblazing women in tech history
1. Jean E. Sammet – The Creator of the First Widely Used Programming Language Jean E. Sammet graduated with an....
12 questions to ask before investing in paperless validation
Regulatory expectations related to GxP validation have increased in both inspection focus and in complexity. And it doesn’t get any....
Paperless validation system versus a hybrid paper system
In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are....
The 4 types of process validation
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes....
FAT vs. SAT
It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This....