Quick Tip: Simplify CSV with a risk-based approach
A more flexible regulatory environment is now emerging to support rapidly changing technology including AI/ML and a risk-based approach to software validation is acceptable.
Are you feeling the heavy burden of excessive testing and documentation when doing software validation?
You are not alone! A compliance-focused mindset in the medical device industry has resulted in a heavy burden for software testing and documentation even in applications that do not directly impact product quality or patient safety. Our industry has been slow to adopt the latest technology in computer and automated data processing systems that can help improve quality and safety of medicinal products and medical devices. Further, changes to currently validated systems becomes a herculean task due to perceived documentation requirements for regulatory compliance.
Even the FDA seems to have realized this problem! In a newly released draft guidance related to software used as part of production or the quality system, the agency is emphasizing the need for a risk-based approach.
The new buzzword is Computer System Assurance (CSA), not validation. The focus is on Quality, and not on testing for the sake of testing and documentation.
Applying critical thinking can help you to use a risk-based approach. Think about your patients and users first. Develop your testing strategy based on risk, not based on an arbitrary requirement. Take a hard look at your procedures and work instructions to make sure they focus on risk when defining requirements for testing and documentation.
We need to have procedures and work instructions written for the benefit of people who do the work, not for the benefit of auditors.
Regulatory agencies realize that technology is moving fast. FDA, in particular, is creating a more flexible regulatory framework for software-based devices.
We have a unique opportunity in this new environment to help accelerate product innovation by taking a risk-based approach in meeting regulatory requirements.
