What Compliance Software Vendors Won't Tell You About FDA Audits and Real Plant Life
Most pharma and food plants spend $200K-$500K annually on compliance software that catches zero violations auditors actually care about. Here's what your vendor isn't saying about what actually matters in an FDA inspection.
There is a persistent lie baked into every pitch deck for pharmaceutical and food manufacturing compliance software, and it costs plants real money every year. The lie sounds like this: install our platform, feed it your data, and you will pass your FDA audit. What actually happens is plants wind up with a bloated database, a team of people feeding excel spreadsheets into a software box, and auditors who still find the same problems they found last time.
The problem is not that compliance tech is useless. It is that vendors sell the fantasy of passive compliance: the idea that software can do the work for you. It cannot. Compliance is not a technology problem. It is an operations problem with a technology component.
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