Managing Automation - January 2008 - (Page 36) [JANUARY 2008] Transformation Integration TechWatch Industries [ TRANSFORMATION ] Giving Up the Driven by FDA regulations, medical device manufacturers are rethinking key business processes and implementing integrated systems to bolster their quality management practices. B Y B E T H S TA C K P O L E PAPER CHASE or 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 paperbased signatures.” Like Optos, many manufacturers in the medical device arena are ready to give up the paper chase when it comes to quality management practices. Spurred on by ever more stringent FDA directives that regulate everything from how companies develop and manufacture products to how they respond to customer-driven corrective and preventive actions (CAPA), medical device makers are taking a fresh look at their outdated paperbased quality procedures and limited Word document and spreadsheet-based systems. They are implementing software platforms to modify and streamline quality-related business processes in an ma January 36 2008 Illustration: Stephanie Carter
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