Software development and testing methodologies have evolved tremendously since the current FDA regulations on Computer System Validation for the life sciences industry were released. The FDA is now shifting its focus from Computer System Validation (CSV) to Computer Software Assurance (CSA) to reflect lessons learned from FDA studies and updating its guidelines for software quality based on technological advances such as automation.
The FDA and CDRH (Centre for Devices and Radiological Health) formulated the ‘Case for Quality’ program in 2011 following evaluation of statistical data and input from both the FDA and industry stakeholders. The FDA’s analysis recognized prevalent manufacturing risks that can impact product quality and patient/consumer health. This led the FDA to develop their Computer Software Assurance guidelines with a prime focus on quality by treating compliance attainment as the baseline and considering the inclusion of critical quality practices that result in higher-quality outcomes.
The to-be Computer Software Assurance process is focused on identifying the intended use of the medical device or software system, checking its impact on patient / product safety and quality, identifying related risks, applying critical thinking and assurance needs, then executing testing and generating assurance documentation.
Pharma companies and device manufacturers are expected to provide a higher degree of assurance by applying critical thinking across system functions, business processes and mitigating all related risks that directly impact patient safety, product quality, and data integrity. We are tailoring our services to meet these new guidelines accordingly. Please reach out to our team at Prana Life Sciences if you would like assistance navigating the FDA’s new guidance document “Computer Software Assurance for Manufacturing, Operations and Quality System Software” that is scheduled for release in 2022.
