Biotech and medical device companies are regulated by national and international regulatory bodies (FDA 21 CFR Part 11-820 & IS0-13485.75). There are strict guidelines that must be followed, especially when the goods produced by these companies are for human-use or clinical studies. Computer System Validation (CSV) is one of those compliance requirements and is part of the Quality Management System within pharmaceutical and medical device manufacturing. In addition, it is a good business practice to ensure that the equipment/systems used in the production or testing of product for human-use are compliant. That, it functions as expected and the safety of the user, environment, and security of the computer system (CSV) is not comprised. Many businesses invest so much money on equipment and computer systems, but they ignore key essentials to the quality and performance of their computer systems. Thus, leading to waste of resources and unforeseen delays in their product’s approval.
For further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us.