Understanding Computer Software Assurance (CSA)

Life sciences organizations rely on computer systems to ensure the safety and quality of their products. These systems require validation to ensure they are fit for their intended use. However, the traditional approach to Computer System Validation (CSV) has created a burden that inhibits the adoption of new technologies.

In response, the FDA has released draft guidance for a new risk-based approach: Computer Software Assurance (CSA). This eBook explores the key aspects of CSA, including its impact on the life sciences industry, the benefits of adopting CSA, and the advantages of using digital validation tools. CSA offers a streamlined approach to validation, prioritizing testing efforts based on risk and leveraging vendor testing and documentation. This shift in focus reduces the validation burden and allows for quicker implementation of innovative technologies without compromising quality or patient safety.

Download the eBook below to and access these valuable insights into navigating the changing landscape of CSA in the life sciences industry.