Prodigal
I apologize for the extended absence. I've been putting in tons of time not only on my day job, but also on my presentation for DIA CDM, which is coming up very soon. I've also been approached just today for a very short-notice but very desirable writing opportunity, so we'll see if I can pull that together in time.
I've been doing a lot of validation remediation lately. I'm on my second project now for one client, and I've been doing a fair amount of it internally as well. Even though I suspect validation remediation makes up a significant amount of time in a given validation consultant's work year, I have had the luxury of not having to come up against it much until recently. Everywhere I've worked, we've dealt with new systems and prospective validation that was done with knowledge of 21 CFR Part 11 and all predicate rules, so I flatter myself that our efforts were relatively comprehensive. Now, though, that I'm calling my own shots and bidding on my own projects, I'm finding that I'm running into validation remediation more and more -- companies don't mind spending the money to bring in someone versed in current guidance and regulations to set things to right because it benefits them so much, and I find it interesting work.
It's rather like figuring out a half-done jigsaw puzzle, with the added challenge of some of the rest of the pieces being missing and others being scattered around the building. I have to figure out what is there and if it was put together appropriately, and once I do that, I need to figure out what other pieces I can find and re-do the ones I can't find. In the end, I come out with a picture that, while it might not look as perfect as the original puzzle would have had it been completed on the first go, is perfectly serviceable and representative of what it was meant to be a picture of in the first place.
I've been doing a lot of validation remediation lately. I'm on my second project now for one client, and I've been doing a fair amount of it internally as well. Even though I suspect validation remediation makes up a significant amount of time in a given validation consultant's work year, I have had the luxury of not having to come up against it much until recently. Everywhere I've worked, we've dealt with new systems and prospective validation that was done with knowledge of 21 CFR Part 11 and all predicate rules, so I flatter myself that our efforts were relatively comprehensive. Now, though, that I'm calling my own shots and bidding on my own projects, I'm finding that I'm running into validation remediation more and more -- companies don't mind spending the money to bring in someone versed in current guidance and regulations to set things to right because it benefits them so much, and I find it interesting work.
It's rather like figuring out a half-done jigsaw puzzle, with the added challenge of some of the rest of the pieces being missing and others being scattered around the building. I have to figure out what is there and if it was put together appropriately, and once I do that, I need to figure out what other pieces I can find and re-do the ones I can't find. In the end, I come out with a picture that, while it might not look as perfect as the original puzzle would have had it been completed on the first go, is perfectly serviceable and representative of what it was meant to be a picture of in the first place.
posted by m at 11:06 AM
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