Validation is broadly applied across the organization to ensure that products, equipment, processes, software and systems operate as designed and intended. Successful validation practices bring together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements. Manufacturers of medical devices must validate any process, including any associated equipment and software, whose entire output is not or cannot be fully verified by inspection. Critical processes that must be validated include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage and distribution.
Synergy Bioscience is experienced in the validation of many types of equipment, processes and systems used in a wide variety of medical device applications. We use a risk-based approach to validation that analyzes each risk for potential harm and likelihood of occurrence in order to focus testing around the most critical functions. To properly evaluate these risks, our staff includes engineers and scientists who understand the technical functionality of the process. We work closely with each client to tailor validation projects to their exact needs.