can u give me the mothod to validate the chromatographic software validation. along with the method to calculate the difference between values obtain manually that to a given by software
Can you tell me what CDS you are looking at? I have qualified PerkinElmer’s TotalChrom CDS in the past. If you are looking at the whole system, then there are many MANY things you need to take into account, such as data storage, data retrieval, user access… and this has to be tied into your company policies/SOPs. I have encountered many people who think that just because a CDS says its 21CFR Part11 compliant then they dont have to do anything with it. They fail to realise that the onus falls on them to set it up and use it in a compliant way! These are all things you need to take into account when looking at these systems.
I agree with Trio . There are Books written on CDS validation showing the importance of CDS validation in RnD departments of bio companies.
there are certain criteria: Like how many clint machines, how many instruments are involved which will let you know how good the validation should be. The "Back and restore’, is an important aspect.
More directly you can look for the CDS validation book in Google books. Limited preview available. but if you are lucky you may find the section for method validation.