We evaluate the processes governing every clinical applications, systems, software, hardware, and equipment involved in your research, to certify your end-products’ quality, safety, and efficacy, and ensure rigorous compliance with regulatory requirements.

Equipment Processes

Our Quality Assurance experts conduct process validation studies, and establish documented evidence that your equipment is capable of continuously delivering high quality results. We plan the study by designing thorough validation protocols that include definitions of your product’s desired specifications along with descriptions of the study’s testable criteria and parameters, testing techniques, and validation methodologies. We conduct Process Performance Qualification studies by simulating actual production conditions, leading series of tests, and analyzing data using statistical methods to determine the standard output for subsequent quality control, detect the equipment’s limits and tolerances, and identify the process variation causes for adjustment and prevention purposes.

Systems and Software

Validation of Regulated Clinical Systems