Stop Validating Computer Systems to Death!
By: Daniel R. Matlis, President
“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices. When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.
FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”
According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients. This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices. Additionally this single-mindedness has led to low rates of investment in automation and digital technologies.
Validation is an Obstacle to Implementing Technology in MedTech
Computer System Validation (CSV) has been a significant obstacle to the implementation of automation and digital technologies in MedTech. This is primarily due to a lack of clarity on the Agency’s part on CSV expectations for automation and technology systems. The FDA recognizes CSV is a barrier to implementation and is working swiftly on addressing this.
“There are two types of problems…Problem A is technical, Problem B is people/cultural. I think everyone would agree the harder problem is people/culture.” said Jason Spiegler, Sr. Director, Industry Portfolio Development at Siemens PLM. “Our mission in our medical device practice is to leverage our technology to help our customers improve the quality of life of their customers, by turning their ideas into reality. These events and the resulting outputs are designed to do this…to create meaningful dialogue to solve the real problems holding our industry back, which ultimately affects us and our families as consumers of medical devices. Siemens already provides holistic best in class software across the entire TPLC, enabling the Digital Enterprise. The technology exists. The real problem is to get the regulators, medical device firms, clinicians, etc to agree on how to drive improvement in a more rapid agile way, where technology can help them realize high product quality and innovation, and all the additional value that goes along for the ride.” added Spiegler.
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