Insight and opinion

Becoming known as the ‘Toyota Production System, this ‘Just in Time’ approach to inventory management provided inventory per production demand…..

The FDA’s new approach, Computer Software Assurance (CSA), represents a significant paradigm shift and places critical thinking at the centre of the CSV process, as opposed to a traditional almost one size fits all approach…..

Regulatory expectations related to GxP validation have increased in both inspection focus and in complexity. And it doesn’t get any easier when your company expands, with the related validation deliverables, effort and compliance risks increasing further…..

In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are seeking to optimize their Validation processes. In doing so they naturally consider going paperless and typically look at an existing IT system, before considering a built for purpose paperless validation solution…..

Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process validation involves a series of activities taking place over the lifecycle of the product and process…..

It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and why each one is required…..