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Overcoming Blockers to Digital Quality Management

May 16, 2023 by MATT LOWE

Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in a regulated industry, processes tend to get more locked in because compliance is at stake. That was certainly the case when I worked in the medical device industry. The company I worked for used a paper-based system, and although I could see the benefits of digitizing, I wasn’t able to convince my superiors. It was only when we had a run-in with the U.S. Food and Drug Administration (FDA) and received a Form 483 that things started to change.

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