by
DR » Mon Sep 12, 2005 12:30 pm
If you are in a regulated lab, it will not be worth your time to go down this road because of validation issues. To accomplish CDS validation to the satisfaction, you will need to have executed protocols demonstrating that the software behaves as expected with all sorts of inputs, that it is not fundamentally alterable (this means having source code & compiler available), that the raw data files are secure and not alterable etc. etc. etc.
If you already have lots of data in Agilent's format, I suggest purchasing a CDS from a vendor that deals with that particular format. What you are really purchasing is the reputation that the vendor has with regulatory agencies, technical support, and the vendor takes on the responsibility of validating the software (not your particular applications of it), maintaining source code, answering technical questions during audits etc. etc.
It isn't cheap, but it beats heck out of the alternatives.