How will your company take advantage of the new FDA guidance on Computer Software Assurance (CSA)?

Keeping up with the ever-evolving FDA guidelines regarding regulatory requirements for Life Sciences (CFR21 Part 11) can be challenging. Interpreting and implementing regulations and guidance documents is a time consuming effort that requires a specialized skillset.

Recently the FDA has published guidance and encouraged the risk-based Computer Software Assurance (CSA) strategy. CSA is an evolution and clarification of the Computer System Validation (CSV) approach. CSV is the process of ensuring that your regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner. It has traditionally been implemented in a manner that relies on extensive formal testing of software features. A large set of documentation is generated to prove patient and product safety and reliability. There is often much redundancy in the testing performed by the Life Science Company implementing the system.

With the release of the CSA guidance, the FDA has clarified its stance that patient and product safety is far more critical than onerous documentation. CSA relies more heavily on determining the level of complexity and risk and then targeting formal scripted testing primarily on the highest-risk features of the software. Leveraging vendor documentation and eliminating duplication of effort wherever possible. Many of the same documentation elements are still found in CSA, but with less redundancy and a greater focus on GxP critical functionality.

What can the experienced validation consultants at Apps Associates do for you?

Apps Associates has been providing Oracle-based Life Science solutions for over 20 years. Apps Life Science validation CSA consultants maintain current FDA best practices. Cloud Based systems are particularly suited to leverage vendor documentation. Oracle builds and validates the hardware and base software. Oracle ERP Cloud is a configurable software package, placing it into the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practices (GAMP) category 4. Following a CSA approach, less formal testing will be required than with a custom software solution. Oracle’s quarterly release cycle combined with Apps Associates’ CSA validation approach makes it easy to implement new software features without interrupting the flow of business.

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