Many of us understand computer software assurance (CSA) and its benefits but we often have a common question - is it so simple or how can it be so easy?
Through this whitepaper, we have provided a practitioner’s view of CSA implementation for each GAMP 5 category that will enable organizations to have a smooth transition. With the launch of the new guidance, FDA is focusing on moving away from a compliance-centric approach to a risk-based approach toward validation.
This approach promotes the following:
- Applying critical thinking on risks determination across the life cycle
- Leveraging vendor documentation as needed
- Optimizing the testing rigor
Download the whitepaper to understand how CSA can enable organizations to achieve higher levels of patient safety, product quality and data integrity.