Topic: Computer Software Assurance
Computer Software Assurance (CSA) is a current quality initiative introducing a paradigm shift to enable more streamlined implementation of new technology by removing some computer system validation (CSV) barriers. Interestingly, this reminds me of March 1997 when the FDA finalized 21 CFR Part 11, the regulations for Electronic Records and Electronic Signatures. Part 11 was introduced to allow the adoption of new technology and provide guidance to support electronic signatures, something that had been adopted in less regulated industries many years prior. There was some confusion over the interpretation of Part 11 and it took companies months if not years to implement new SOPs and methodologies. CSA introduces a paradigm shift from testing and documenting everything in a software application to utilizing a risk-based approach to focus on the critical areas. In addition, CSA provides for the reliance on already conducted vendor assurance activities rather than having to reproduce the rigorous testing done by the vendor/provider. So, you may be thinking, what does this mean for the life science industry. Like the adoption and evolution of 21 CFR Part 11, it is going to be a process rather than an overnight change. The Experts at MEDVACON can assist your Life Science Company’s Quality and Information Technology Unit to work together to fully understand the principles identified in CSA and assist in revising the current Quality System to establish provisions for CSA methodology. This is a process involving a culture shift, and this will take time to adopt and eventually evolve into the new norm for testing computer applications. While this may seem daunting, MEDVACON can assist your organization with this journey every step of the way.