CSA supplements the CSV approach for evaluating digital life sciences systems. The end goal for both CSV and CSA is to ensure that the software is not a threat to patient safety or product quality. However, CSA enables a more flexible and agile process.
In September 2022, the Food and Drug Administration (FDA) released a new draft guidance titled “Computer Software Assurance for Production and Quality System Software”. Although this guidance is targeted for computer systems and software as part of medical device production, it will set the tone for how the life sciences industry approaches software validation in general.
When finalized, the guidance for Computer Software Assurance (CSA) will supplement the FDA’s guidance for Computer System Validation (CSV) which has defined how life sciences companies approach digital systems since 2002. These changes have been eagerly awaited by the industry, as the CSV approach can be burdensome and time-consuming, especially due to extensive documentation requirements.
Since CSA is better suited to enable the use of modern digital solutions, including automation, cloud services and SaaS, it is enabling the industry to produce medicine of higher quality. In this respect, CSA can be seen as part of a broader industry trend which also includes the changes to the GAMP 5 Second Edition and the shift towards Pharma 4.0 digitalized solutions. Both CSA and GAMP 5 Second Edition recognize the cyclical nature of modern software development with frequent updates and feature releases, which requires a more agile and non-linear approach.
In this webinar, we will introduce the main points of CSA, compare CSA to CSV and explain what pharma companies can do to prepare for this new paradigm, for example by reevaluating and adapting their QA procedures.
The webinar will cover:
- An introduction to the background and regulatory framework including the FDA draft guidance for CSA.
- From CSV to CSA. Outline of the new paradigm.
- CSV vs. CSA. A summary of key similarities and differences.
- How to prepare a sound foundation for your organization’s implementation of CSA.
How can NNIT help? Overview of service offerings and next steps