Why do we need a document control process?
Oh, if only I had a nickel for every time I’ve been asked that question. Or this one:
“Ok, Michelle, the quality manual and training are important – got it. But what’s all this kerfluffle about documentation? We write most things down, and have nice, neat binder files…….documentation is all you regulatory people ever seem to worry about”
Well, yeah. 🙄 But there are good reasons why regulatory nerds like myself get so wound up about documentation. And those nifty new binders you put together just before the FDA inspection won’t do you any good if you don’t have a solid document control process to back them up.
Because controlled documents are THE ONLY WAY to show compliance with the CFR (THE ONLY WAY, do you hear me?)
A robust document control process is what keeps your documentation organized and up to date, because the FDA hates outdated files almost as much as they hate missing files. Almost.
If it isn’t documented, IT DIDN’T HAPPEN, and you won’t be able to convince the FDA otherwise.
Side note – screen captures do not a controlled document make. Write that down.
If you didn’t do it, DON’T DOCUMENT IT (no maintenance by the pen, please. And no frantic last-minute CAPA printing and signing parties either)
Check out my website for even more cool regulatory stuff: https://leanraqa.com/
My YouTube channel has even more fun stuff: https://www.youtube.com/watch?v=rkV74D5i1Ts