Workshop A – Moving from Computer System Validation to a Computer Software Assurance Model

Time: 10:00 am - 12:00 pm
day: Pre-Conference Workshop Day


The updated CSA framework is changing the paradigm on
how computer system validation is performed. Designed to
help manufacturers achieve compliance through their digital
transformation journeys – from electronic document workflow
using electronic signatures to the implementation of artificial
intelligence – the new CSA draft will provide clarity on the stance
and methodology used to determine what is high risk and what
is not, therefore minimizing misinterpretation by manufacturers.
The clarification in the CSA approach flips the model to focus on
critical thinking (risk-based), assurance needs, testing activities, and
documentation, in that order.

Join this workshop to:
• Identify the best and most effective strategy for your transition
• Prepare for the new documentation requirements
• Update your business processes to focus on quality assurance,
patient and product safety, and data integrity