COMPLIANCE ACCELERATED Case Study 1 MicroMed Executives Offer Insights Not too long ago, Fridays at MicroMed Cardiovascular Inc. meant sitting down around a big table with a pile of documents—all the CAPAs, noncompliance issues, and product design changes for the week. The goal: to review and approve all the documents in one sitting. It was decidedly not a TGIF occasion. All stakeholders picked a document, reviewed it, and tried to make sense of all the changes before passing it to the next person. “It was our ritual every Friday,” said Sailesh Saxena, MicroMed’s CFO. “In my mind, the process was error prone. It was manual and wasted a lot of valuable time.” Anthony W. Williams, VP for operations, agreed. “We spent four hours [every Friday] managing documentation, discussing it,

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