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One of the world’s top 10 global medical devices and pharmaceutical manufacturers was looking for prospective and retrospective validation of Commercial off-the Shelf (COTS) software tools used by their research department. The US Food Drug Administration (USFDA) has stringent guidelines for Computer Systems Validations (CSV). Successful validation demands that a number of underlying supporting processes are satisfactorily met. These processes include document management, change control, configuration management, requirements traceability, self-inspections and training. These procedures make the process critical as well as important. Syntel’s unique risk based frameworks and methodologies, coupled with customized tools and accelerators, contributed to quality compliance, productivity and efficiency.