10:00 – 12:00
Farmaforum Workshop Room 1
GAMP: Approach to Computer Software Assurance (CSA)
Bárbara Sanz, Operations Manager, CSV/CSA, Data Integrity Advisor & Partner
“Computer Software Assurance (CSA) is the new approach to the validation of computerized systems used in the pharmaceutical and medical device industry.
This approach is based on the recognition that computerized systems are increasingly complex and that their traditional validation can be costly, inefficient and does not always guarantee product quality and safety. CSA focuses on software quality assurance throughout the product lifecycle by implementing software development practices that address error prevention, early defect detection and risk mitigation.
Therefore, it is important to know what this new approach entails, and how to apply it in the validation of computerized systems. In other words, it establishes a framework for managing the software life cycle, which includes planning, development, validation, implementation, maintenance and retirement of the software.