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Quality Risk Management Strategies for Computer Systems Validation
(Polytechnic University of Puerto Rico, 2014)
Quality Risk Management is something
that has been gaining attention in the regulated
industry because it is listed as regulation in various
regulatory agencies such as FDA, ICH, ISO, ISPE
and other involved regulatory ...
Smart Camera Mimics Humans Decision Making Process in a Vial Crimp Quality Automated Inspection Process
(Polytechnic University of Puerto Rico, 2013)
Crimp quality is an important attribute
in the vial filling process. It protects the sterility of
the product from manufacturing until it is dispensed.
A pharmaceutical company performed a Failure
Mode and Effect ...
Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
(Polytechnic University of Puerto Rico, 2013)
In the pharmaceutical industry every
product and every process associated with risks.
To maintain product quality throughout the product
life cycle, too much time and resources are
allocated. Risk is described in recent ...