Situation_ VSAM Knowledge Solutions provided a resource to manage calibration, qualification and validation for 10 LC-MS/MS computerized systems on both hardware and software and for all 70 pieces of laboratory equipment and instrumentation used in the conduct of studies.
Obstacle__ 7 different software retrospective validations were to be completed within 1 year.
Actions __The resource managed the C&V group to deliver validation of the software and reviewed and completed and reported all SDLC deliverables and scheduled execution activities during production gaps. All software validation was templated using CA Validator software.
Results_ Software retrospective validation was completed on time and any deviations were resolved, implemented and closed.
