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What’s this whole QA thing anyway?

Posted Oct 23 2008 1:44pm

Friends and family are often perplexed by what I do. People in fields related to health care are often unsure of what I do. Even Pharma colleagues in other departments hold some misconceptions as to what a Quality Assurance Auditor actually is.

A few years ago, I told my cousin (whose father is an accountant) that I’m an auditor. That surprised her since her father is involved in financial audits and she knew my background was in the sciences (and not in a financial field). I explained that I audit for compliance with FDA regulations and that seemed to clear it up some, but I’m sure it was still a little foggy even then.

Even a young physician I was seeing for the first time (for a yearly physical) asked what a “Clinical Auditor” was since I had indicated that as my profession on his intake form. “Well”, I answered, “do you ever conduct Clinical Trials here? ” Understanding stole across his face. “Oh, that kind of auditor”. He laughed nervously. I get that a lot from physicians, especially younger physicians who haven’t had a lot of actual exposure to regulated research….they often view me like I’m from the IRS. Not to malign the IRS, but I think you take my meaning.

Here it is in a nut shell: In the pharmaceutical industry, a QA Auditor is concerned with evaluating either the methods, systems, and processes for the research or production of drugs. We have many standards in the form of laws, regulations, conventions, etc., but essentially it distills down to two big ones:

1) Safety (Is this substance safe for the intended population to be using?) and

2) Data Integrity (Does the evidence that shows that the substance does what it is suppose to any good?)

Now that’s a pretty high level definition that does little to explain the “when, where, how, or why” of the matter. “What”, for that matter, is still a little vague. Don’t worry, I’ll be building on this. Stick with me.

~TJK

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