Although risk-based software validation is already a best practice, many life science companies are still reluctant to reduce validation activities and/or documentation using risk-based decisions. One reason for this is that the relevant software validation regulations are very general and companies
- either do not know exactly how they should be interpreted
- or they fear that the authorities may have a different interpretation/expectation.
The result is that these companies either do not take a risk-based approach at all or, more often, despite taking a risk-based approach, still focus primarily on extensive validation documentation rather than on risk to the patient or product quality, as well as the software quality itself.
A group of life science industry representatives has teamed up with the FDA to launch an initiative to promote a risk-based approach that focuses more on software quality while significantly reduces the documentation burden. The result is what is called Computer Software Assurance (CSA), for which the FDA will publish a related guidance document (Guidance for Industry).
In this webinar, you will learn first-hand what CSA is all about from one of the founders of the so-called FDA-Industry CSA Team (FICSA), which created CSA and produced the associated guidance document. You will learn how to integrate CSA ideas into existing validation processes, why you should do so, and what benefits you can expect.
The webinar is aimed at employees from the pharmaceutical industry and suppliers who are currently and, in the future, involved in the topic of CSA in the IT environment.