Letting non-software engineers validate standard software saves much money, Vogel, Ph.D., writes. "Non-software engineers should be able to validate most software categorized as off-the-shelf or embedded," he says. Higher-priced software engineers must validate custom-developed, complex, or highly risky software.
The article covers the regulatory background, what kinds of software must be validated, what FDA definitions of verification and validation, key validation components, and the concept of 100% verifiable output.
Vogel's article, "Validating Software for Manufacturing Processes," can be read online at http://www.devicelink.com/mddi/archive/06/05/006.html.
Vogel is a top national expert in medical device software development and validation. Intertech, in Norwood, Mass., offers requirements management, development services, validation services, consultation, workshops, and training to medical device manufacturers nationally. For more information, contact Vogel at 781-255-5420 or Email Contact. Web: www.inea.com.
Contact: Henry Stimpson Stimpson Communications 508-647-0705 Email Contact David A. Vogel Intertech 781-255-5420 Email Contact