FDA Validation Help


Thread Starter


My company is currently involved with cGMP compliance activities, and have come to the Bailey DCS system. We are not a "batch" operation, so, it is difficult to "validate" the system, as you would a "batch" process. (ABB already sells a batch product, which, I believe comes with validation issues in mind [electronic signature stuff, etc.]
There are "lots" of consultants out there who can "validate" our system, but we would rather learn the process ourselves.
Any help or a pont in the right direction would be appreciated.
qc_man, NWSCO

Anthony Calia

My company provides electronic inspection systems to the pharmaceutical community, and every system we install (vision, bar code etc.) requires validation. You will find that the validation requirements of each company differ, and that some have painted themselves into a corner by using validation consultants who get paid by the pound of paper they produce.

Your best bet is to view other validation protocols executed by this company, and look at the structure and content. Once you have an outline, you can produce a similar document which addresses the system you installed. If you choose to use a consultant, hold onto your shorts....
Thanks, Anthony. I totally agree with your comments. Is there a place to get "sample" validation protocols? I have even thought about 3rd party software packages, but I am failing to find any.