If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are necessary to bring needed medical products to market and monitor them to protect consumers and patients from unsafe products.

In this article, we won't explore audit management systems (AMS) in detail. Nor will we be determining whether an AMS is needed, since this depends on the number of audits and inspections we face. Instead, we’ll focus on how to modernize audit/inspection readiness, conduct, and closure using existing systems while incorporating a digital validation solution to support the audit/inspection.

Because audits and inspections are vital for public health, we must ensure they’re embraced, supported, conducted, and achieve their objectives. Let’s take a quick look at audits and inspections to understand the differences and challenges they bring to bear.

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