The End of Validation

December 09, 2019 Kevin Martin

A deep-dive into the FDA's new draft guidance for Computer Software Assurance for Manufacturing, Operations, and Quality System Software.

Since its inception, the Center for Devices and Radiologic Health (CDRH) has operated with the vision of providing patients with “access to high-quality, safe, and effective medical devices of public health importance first in the world.”

A department of the U.S. Food and Drug Administration (FDA), CDRH promotes quality medical devices and radiation-emitting products through facilitating innovation throughout the United States by advancing regulatory science, providing industry with consistent and transparent pathways for treatment and use, and assuring consumer confidence in marketing devices. Basically, CDRH authors the pathways to approval that manufacturers must follow during Step 3 of the five-step medical device development process, prior to FDA review.

To help steady the device industry’s regulatory plod when it comes to manufacturing software, later this year the FDA is issuing Draft Guidance or Computer Software Assurance for Manufacturing, Operations, and Quality System Software.

When compared to the pharmaceutical and biotech industry, it’s oft-noted that medical device manufacturers are behind their counterparts when it comes to software validation. The reason for the lag, it’s suspected, lies in the differentiation between the devices’ native software as opposed to the software used to manufacture the devices.

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Kevin Martin

Kevin has nearly 40 years of FDA regulated industry experience that includes management positions at Wyeth and J&J/McNeil Pharmaceutical. Kevin's experience spans projects conducted within QA, IT/IM, Manufacturing / Operations, Clinical and R&D. Kevin is a former member of the PhRMA Computer Systems Validation Committee, a former chair of the ISPE DVC CSV Sub-Committee, a former Core Team member for the PDA Part 11 Task Group, and past Chair of GAMP Americas Steering Committee, past Co-Chair of GAMP Global, and former Sponsor to the GAMP Risk Management Special Interest Group. Kevin has a Bachelor Degree in Chemistry from Delaware Valley College of Science and Agriculture and a Master of Engineering in Manufacturing Systems from Penn State University.
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