One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to assist the Pharma 4.0™ digital transformation by enabling seamless integration and interoperability between all systems components and operational technology to advance the overall digital maturity toward predictive and adaptable operations.
The FDA recommended CSA seeks to speed Computer System Validation (CSV) without sacrificing quality, but there’s a lot to know before you get started. This eBook, authored by CSV expert Darren Geaney, will give you a foundation of understanding so you can take the first step in your CSA journey with confidence.