JVT Journal Articles
Vol. 24, Issue 1, Feb 2018

Allan Marinelli
If the client does not successfully define short and long-term objectives, the project will fail leading companies to potentially receive unnecessarily large amounts of FDA (Food and Drug Administration) 483 (s), warning letters, and other penalties.
Ivan Soto
This whitepaper summarizes the challenges found in the traditional validation process and the benefits achieved by implementing Validation Lifecycle Management Systems (VLMS).
William R. Porter
“Fake” or synthetic data, properly constructed, can be used as a tool for validating procedures and software used in the analysis and interpretation of experiments that can be modeled mathematically. Well-crafted “fake” data” must be granular, with the same level of granularity that would be encountered in the measurement of real data and must...
Roberta Goode
Process validation begins with determining risk, not only in the manufacturing process but also in the design and use of the device. Risk assessment and management is the logical foundation of engineering, especially in the medical device industry, and it is required by regulatory bodies.
Paul L. Pluta
The site Validation Approval Committee (VAC) has a vital responsibility to the manufacturing site and is critical to the success of the site validation program. Whatever structure and content, the site VAC should consider the VMP as their document. The VAC should consider themselves to be a surrogate FDA (or other regulatory agency) auditor when...