Bioequivalence and Bioavailability Forum

Dear Ohlbe,

❝ I'm not sure I could totally blame them considering the recent accumulation of data integrity issues reported in warning letters. See the latest (...)

Wow, thanks for bringing this to my attention. Some really, really scary sh!t going on there.
Interesting that the FDA are commenting, actually almost helping, the inspectee define the appropriate role of the Data Integrity Consultant. Or let's call her/him a DIC to spare the keyboard.
The FDA is clearly telling the inspectee here that even though the actual errors, e.g. tampering with the balances, may have been done by lab personnel they want an ID of people in management who are and/or were responsible and their potential present influence can be contained as a PA. This is an elegant and useful way of saying that the inspectee can't take the easy way out and just point fingers at some lab technicians, fire them and expect that it all goes away.

Finally, I completely love the term "management behaviour", which is part of what the DIC must look at.
There's clearly an unmeet need here; I imagine ASQ, CfPIE, RABQSA etc will soon establish trainings called something like "Assessing management behaviours for DICs".
_{[CfPIE: Feel free to trademark that title. It's all yours.]}