The Journal of Validation Technology
Vol. 22, Issue 4, Aug 2016

Frank E. Matos and Jennifer Reyes
The MALDI-TOF is a rapid identification system that identifies microorganisms by creating a finger print of highly abundant proteins that is compared to a library of known species to produce an identification result to the genus or species level. A comprehensive and well-structured Laboratory Equipment Qualification Program (LEQ) facilitated the...
Tim Sandle
The aim of this paper is to assess the current regulations relating to computer system validation, focusing on software (although reference is also made to hardware). The paper provides some best practice advice for the risk assessment of computerized systems.
The Annual Product review (APR) is one of the most critical and useful tools that a company has in its quality arsenal. If done properly, it will be a decision making tool for validation, production, quality investigations, process optimization, training, and quality systems development. These are just a few of the uses, however, as this paper...
Alexander Delli Paoli, Jr.
Filtration and distribution of air are operations of the heating, ventilation, and air conditioning (HVAC) process that deliver processed air at the desired flow rate, pressurization, containment, and particulate quality to maintain desired conditions in the facility or manufacturing process. These functions are the “dry side” of HVAC. Filtration...
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