Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns
• By Shawn M. Schmitt
Capturing and analyzing product quality data appears to be a hiccup for many firms, but the problem can be addressed through the use of proper tools and effective monitoring of quality data sources, FDA officials explain. When quality data is added to a manufacturer’s CAPA system and properly analyzed, device problems may be discovered more quickly. Further, firms that inadequately define data sources in their procedures and mishandle information coming out of those sources will attract the notice of FDA investigators. “I would urge you to sit down with the investigator and show them your quality data elements and where the data is coming from, as well as how that information is analyzed,” said Phil Pontikos, FDA’s national expert on medical devices. “If you share those processes upfront, I think it will help expedite the inspection.”
Many device manufacturers aren’t doing a good job of capturing and analyzing product quality data – a misstep that could lead to FDA regulatory action, agency officials say.
“I’m sure most firms would say they have their quality data sources clearly identified. I’m going to tell you that...
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