TABLE OF CONTENTS There are a number of concepts and terms that we need to get right before we start the detailed journey into validation of your CDS in the following chapters of this book.
Let us start from the beginning and ask this fundamental question as there are a number of reasons for validating your CDS.
Investment protection. How much money does your laboratory waste buying software and systems that fail to meet expectations? Validation is a way of building quality into a system and increases the chances that the chromatograph and its software will meet expectations. Therefore, the investment that an organisation makes is protected from purchase on a whim or, worse, from the end of year budget spend. You know the scenario; your boss puts his/her head round the door and asks if you can spend / /$100,000 in 3 weeks (get three competitive quotes, assess the systems, raise the PO and have the empty box delivered to stores by the end of the financial year). Perhaps this always happens only in other organisations?
Consistent product quality. Product quality should be considered in a broad context. The product of a laboratory is information on which to base decisions. Therefore, in R&D laboratories software validation is used to ensure that the results you generate to support product development are correct. Chromatography is a key analytical technique that is heavily involved with R&D and manufacturing and it is important to know data...
