Documentation 'R' Us
Posted: Tue Feb 03, 2009 9:23 am
We are building a new facility. All of the individual utilities and major pieces of equipment need qualifications - installation (IQ), operation (OQ) and performance or process (PQ). Each of those qualifications requires a protocol, reviewed and approved prior to its execution. I am not writing them, thank ghu, but I am part of the review and approval process. The two currently open on my computer are over 80 pages each. I thought I was up to my pupik in paperwork before.
And just think, once they've been completed, executed, approved and filed, someone from the FDA will come and read them in minute detail, with the purpose of making sure they actually do what they claim to do and the utility/equipment has indeed been successfully qualified. No wonder Washington bureaucrats are so crabby.
And just think, once they've been completed, executed, approved and filed, someone from the FDA will come and read them in minute detail, with the purpose of making sure they actually do what they claim to do and the utility/equipment has indeed been successfully qualified. No wonder Washington bureaucrats are so crabby.