FDA-regulated industry has a problem. And although it has more than one, this one is significant. Despite being the primary method of communication with the US Food and Drug Administration during FDA inspections, writing is a significantly under-emphasized skill. FDA Investigators determine a company’s state of compliance through the company’s written documents. And although many companies try to talk their way through inspections, you can’t talk your way out of bad documents.
As virtually everyone in the industry knows by heart, in the eyes of the FDA, if it wasn’t documented, it wasn’t done. The Writing for Compliance® corollary to that rule is: “If the FDA Investigator can’t understand what you did, and why you did it, and why the action was in conformance with FDA requirements and expectations, you might have well not have done it.”
During our development and delivery of the Writing for Compliance® Workshop, we have identified that the vast majority of people that are tasked with writing and reviewing compliance-implicated documents have had little to no training in specific writing skills. Of all prior respondents, 66% had 1 or less college writing course. Of all prior respondents, 85% had 1 or less business writing course. However, two-thirds of respondents think compliance implicated writing is a significant problem. And only 10% of writers consider themselves experts, despite over 40% writing frequently and 58% reviewing frequently.
We don’t think it’s a stretch to ask: Could this be why we often have significant problems during FDA inspections?