S&A specializes in complex automated systems validations (particularly the software and human factors aspects), that are normally not well treated by other firms (but are of increasing concern to the FDA). Our focus is on functionality, usability, reliability, performance, and supportability. We provide customized training, techniques, and tools that achieve a complete and correct system validation. We assist both the system developers (from conceptualization through installation) and the system users (from acceptance through reconfirmations) in properly implementing the validation lifecycle. We iteratively emphasize, in the context of good project management principles and practices, proper risk analyses (FTA, FMEA, HAZOP), proper requirements management, "just right" reliability engineering (for hardware, software, and human factors), and requisite documentation (e.g., see "SOPs: Facts, Flaws, and Fallacies") that will delight both your management and your regulators. We excel at helping you solve thorny problems at a reasonable price.
S&A provides training, consultations, and technical assistance to your firm's technical staff responsible for solving FDA-mandated (21 CFR §211 and §820) regulatory engineering problems. S&A has worked with the full range of FDA-regulated clients, including members of the top-ten pharmaceutical firms, biomedical equipment vendors, R&D firms, and brand new start-ups. We specialize in validation problems related to automated system development, from both the equipment manufacturers' perspective (software-based systems V&V) and the equipment user's perspective (computer systems validation). We bring to these activities a comprehensive, modern understanding of electronics, electromagnetics, software engineering and human factors engineering knowledge that are often not adequately dealt with in such endeavors.S&A's principal is George M. Samaras, PhD, DSc, PE, CPE, CQE. Dr. Samaras is a professional engineer (PE, MD#13006), a professional ergonomist (CPE, BCPE#950), and certified quality engineer (CQE, ASQ #47597). He received his basic training in Electrical Engineering (BSEE) and earned doctorates in both Physiology (PhD) and Industrial Engineering (DSc); he has a number of biomedical equipment patents and an extensive list of scientific publications in biomedical research. Dr. Samaras worked for the U.S. FDA/CDRH as a scientific reviewer and as Associate Director of Electronics and Computer Science. He was the CEO of a FDA-listed biomedical engineering firm for a decade. He has conducted clinical and laboratory biomedical research, while on the faculty of a major medical school; he has been on the faculty at two major engineering graduate schools teaching technical management, project management, and ergonomics. He is, or has been, a member of the NSPE, IEEE, IIE, IVT and ISPE.