Articles by tag:

CSA

Medical device manufacturing May 6, 2021
Automated Validation: Accelerating MES Implementations in Regulated Environments

The Automated Validation approach is crucial in helping companies to reduce the time and cost of their validation efforts by at least 60-70%.

MES software
Medical device manufacturing February 8, 2021
CSA vs CSV: FDA’s New Guidance for Software Assurance

The CSA ‘represents a step-change in computer system validation, placing critical thinking at the center of the CSV process, as opposed to a traditional ‘one size fits all’ approach.’ CSA helps manufacturers achieve CSV.