A Chromatography Data System (CDS) is a complex software that can be configured to the specific needs of the user’s business process. As such it falls into the Good Automated Manufacturing Practice (GAMP) 5 Category 4 – Configured Products. The validation process is planned and follows along the phases proposed by GAMP 5 for configured products.
The Risk assessment stage of the CDS validation process is to carry out a risk assessment of each function of the User Requirements Specification (URS) determined on if the function is regulatory risk critical or not. The functional risk assessment is made according to the method- Failure Mode and Effects Analysis (FMEA).
The Overall Risk resulting from the Risk Assessment has identified all potential failures requiring mitigating actions/controls. Mitigating actions and testing controls during the PQ phase is implemented.
The final Overall Risk after implementation of Mitigating actions and testing controls during the PQ phase is not more than Medium.
Keywords: chromatography data system, validation of the CDS Software, risk assessment, laboratory data integrity
Developing Defense Strategies from Attack Probability Trees in Software Risk Assessment
