R
Randy-BCEC
It is a two question kind of day for me. We are an old company trying to create a quality system around what we do. As I get deeper, I am finding gaps and I am addressing them in procedures.
The plan is to have all the documentation in place by August 1 so that we have a few months to show evidence that we are using our complete quality system before our next FDA inspection.
So, my second question of the day is, do we need to do anything special to approve a particular procedure for use without having the complete system in place? Should I have written a Control of Documents procedure first? I really want to implement the different segments of the system as they get written instead of waiting until everything is done and approving everything at once.
The plan is to have all the documentation in place by August 1 so that we have a few months to show evidence that we are using our complete quality system before our next FDA inspection.
So, my second question of the day is, do we need to do anything special to approve a particular procedure for use without having the complete system in place? Should I have written a Control of Documents procedure first? I really want to implement the different segments of the system as they get written instead of waiting until everything is done and approving everything at once.