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US FDA Pilot Program Speeds Off-The-Shelf Software Validation

 
• By Elizabeth Orr

The Computer System Validation pilot program is exploring ways for device manufacturers to save time in implementing new information technology tools that support quality systems and other operational functions. One strategy under review: letting companies rely on software manufacturers’ own validation for low-risk functions. Also: A quality assurance manager at device-maker Zoll Medical weighs in on his company's participation in the pilot.

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Device companies could speed the validation process for some new software by relying more heavily on software manufacturers' own validation procedures for low-risk functions, a little-noted US FDA pilot program has found.

The Computer System Validation (CSV) pilot launched in March 2016 and grew from an attempt by FDA to clarify its...

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