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A Tale of Two Labs: When the FDA comes knocking at your bioanalytical lab…

27th Apr 2017

A tale of two labs… it really was the best of times, for one of them, that is. The other, well…

Okay, I’ll admit my literary prospects aren’t going to be golden highlights of my career – but picture the scene. Your bioanalytical lab has just landed a long-term strategic partnership with a leading biopharmaceutical company. With lowering margins and rising staffing needs, there’s a lot at stake in getting life-saving medicines to patients.

Your lab relies on E-WorkBook to drive scientific rigor, compliance, and quality control across the entire bioanalytical work stream. Your QA team harnesses IDBS’ Audit by Exception to quickly surface process exceptions that your method permits. All others are flagged for resolution at the time of execution, not after the fact.

So, when the FDA auditor comes knocking, you simply get them to log in to a controlled portal that contains the bioanalytical method, all the materials used to execute the method, every piece of equipment that was utilized, all exceptions that were encountered, and more importantly, their resolution.

It seems too good to be true, right?

Before you pass this off as a work of fiction, take a look at what the folks at AIT Bioscience have to say about their FDA audit, conducted entirely within E-WorkBook.

But, not every story ends so smoothly. How would a lab using more traditional methods to execute bioanalytical studies, cope when the FDA came knocking? As you’ve made it to the end of the blog, you’ll already know the answer – the audit report won’t be light reading… and don’t expect a happy ending.

If you’d like to make sure you’re ready to meet the FDA head on then talk to one of our experts today.

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Joe Rajarao