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by Beth Stackpole, Contributing Editor Posted on Monday, January 07, 2008 11:04:28 AM   | Abstract: | Driven by FDA regulations, medical device manufacturers are rethinking key business processes and implementing integrated systems to bolster their quality management practices. |
For years, as a quality manager in the medical device arena, Leticia Booth lived in fear of a Food and Drug Administration audit. Then, in October 2007, Booth came face to face with her biggest nightmare. Optos, the Marlborough, MA-based retinal imaging device manufacturer where she works, received five calendar days' notice of the FDA's planned on-site inspection of the company's production facilities and business processes to ensure regulatory compliance. Though the visit wasn't unexpected — Booth knew it would happen two years in advance — even the company's diligent, nearly yearlong preparation, which included implementing a quality management system from IBS America Inc., didn't allay her trepidation. When the day finally arrived for the FDA audit, the scheduled two- to five-day inspection was a wrap in just under four hours. The result: Optos passed all of the compliance benchmarks with flying colors. "Our records were impeccable. Our documents were impeccable. Everything was absolutely spotless," Booth says. "It was easy to do with [IBS] CompliantPro because everything was automatic and we weren't chasing down paper and paper-based signatures." [Click to continue] |