CDS: A Chromatographic Data System (CDS) is a computerized system that facilitates the definition, management and execution of chromatographic-based analysis. It allows the management of the analytical instrument (i.e. changing the temperature of a column, the detector wavelength or the gradient between several solutions), the acquisition of data, its adequate storing and processing including reports generation.
CSV: Computerized System Validation (CSV) is defined in the following way by FDA: “Computer system validation is the process of providing a high degree of assurance through documented evidence that a computer system consistently meet(s) its pre-determined or intended use or quality attributes such as accuracy, security, reliability and functionality.”
Why Validate a CDS?
The regulatory inspections of these systems demonstrated the level of documentation provided by a vendor, which usually includes a significant amount of vendor-recommended requirements, testing scenarios and documented evidence of executed verifications including vendor quality unit final approval of executed activity. This vendor package is typically presented in several hundreds - even thousands - of pages; so, the frequently asked question is: Why do I need to perform a Validation activity if a vendor built/executed this significant amount of verifications?
The main reason for executing a Validation exercise is that the vendor is not necessarily aware of your specific intended uses of the system, including which role you plan to select for the execution of some activity, which configurations you are going to apply and which instruments you will use via the identified CDS.
For this reason, it is required to perform a set of customer-specific verifications (often termed Site Acceptance Testing = SAT), in addition to the vendor documentation (often termed Factory Acceptance Testing = FAT).
Clearly, a Validation exercise is required. The following provides more detail regarding the Validation activity.
Can the same vendor verifications be re-executed?
As stated earlier, the scope and goal of Factory Acceptance Testing and the System Validation are different. System Validation is focused on the intended use; this means that it is not required to verify each software functionality but the portions of the software, the functionalities and components that are required for the execution of the identified processes and analytical operations. For this reason, the Computerized System Validation should not be a simple repetition of existing verifications but should be focused on specific needs and formally identified as a set of requirements.
How to Validate a CDS