FDA-regulated validation in clinical and nonclinical environments (Regulatory Affairs)

System validation is a multiphase process which demonstrates that a laboratory instrument or piece of medical equipment functions as intended, is “fit” for use per acceptance criteria, and meets the Food and Drug Administration’s (FDA’s) guidelines and user expectations. It is field testing from the end user’s perspective, above and beyond the detailed testing performed by developers and manufacturers. The clinical environment (i.e., involving humans) has more validation requirements than the preclinical environment (i.e., involving animals or invitro) due to the different usage, yet the foundation is the same [1]–[5]. System validation is performed at the end-user company’s site, except for devices identified by the FDA that are to be tested at the manufacturer’s site.