Wednesday November 25 2009 | Biotechnology feed | All feeds
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Samaras & Associates, Inc.
Download detailed PDF Members: 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.
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