Managing critical systems is a key endeavor whose central focus is the validation lifecycle. Throughout the validation lifecycle, the focus is on functionality, usability, reliability, performance, and supportability. The validation lifecycle consists of the initial validation and subsequent reconfirmations, both on a periodic basis and as the result of a system change or an incident. For FDA regulated firms, validation is mandated in the Code of Federal Regulations (21CFR211.68 and 21CFR820.30(g). Properly managing the validation lifecycle is a complicated task; it can be dramatically simplified with the proper tools and techniques.
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.
There is a correct way of validating an automated system (a priori validation), an acceptable way (a posteriori validation), and a myriad of incorrect or incomplete ways of validating a system. The correct way, consistent with ISO/IEEE guidelines, is to implement the requirements management process concurrently with the conceptualization, design, development, and testing processes. When this has not been done correctly - since one cannot travel back in time - there still exists an acceptable means of system validation. This consists of developing a thorough hazard analysis, usually based upon the system's operative specifications and a HAZOP study (often augmented by a FTA or FMEA). From this is derived a comprehensive validation test plan which addresses issues such as critical decision paths, alarms & sensors, security, ergonomics, algorithms & recipes, power loss & restoration, and application code evaluation. Specific test protocols are developed, executed, and the results analyzed, documented and used as baseline data for subsequent reconfirmation efforts. These results support the formulation of a structured assurance case.
Samaras & Associates, Inc. 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. Samaras & Associates, Inc. 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 V&V) and the equipment user's perspective (validation of automated/computerized systems). We bring to these activities a detailed, comprehensive, and modern understanding of electronics, electromagnetics, software engineering and human factors engineering knowledge that are often not adequately dealt with in such endeavors. We espouse a zero-base documentation approach.
Dr. George Samaras is a registered Professional Engineer (MD#13006) a Certified Quality Engineer (ASQ #47957) and a Certified Professional Ergonomist (BCPE#950). 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.