The upcoming draft guidance on computer software assurance (CSA) is a complete paradigm shift from document-focused computer system validation to critical thinking assurance practices.
This isn't nearly as dramatic as it sounds.
The FDA has advised life sciences companies to take a risk-based, least burdensome approach to CSV for two decades. These guidelines are not new. Adhering to them, however, has been a challenge for many organizations. Enter CSA.
What is CSA in a nutshell?
The CSA methodology supports product quality and patient safety by emphasizing the use of critical thinking and digital technologies over burdensome testing and documentation. By streamlining the validation process, CSA can help you achieve faster deployment and ROI.
CSV is not going away. Riskier applications will always require rigorous validation. But CSA is the wave of future and a better way to perform CSV.
Articles and podcasts about CSA
Check out our 5-part series devoted to CSA. Written by validation expert Steve Thompson, each post includes a link to a companion podcast that offers a deeper dive into the topic.
Lisa Weeks, the marketing communications director at ValGenesis, writes extensively about technology, the life sciences and other regulated environments. Her work has appeared in many industry publications, including Life Science Leader, Quality Digest, Medical Product Manufacturing NEWS (MPMN), MedTech Pulse, Risk Insights, Medical Device and Diagnostic Industry (MD+DI), Medical Product Outsourcing (MPO), MedTech Intelligence, Pharmaceutical Processing, Pharma Manufacturing, Genetic Engineering & Biotechnology News (GEN) and Pharmaceutical Technology (PharmTech).