Auflistung Nach Schlagwort "Pharmaceutical industry--Data processing"
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Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2018)Computer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original ... -
CSV Program Implementation using a Risk Based Approach to align ICH with GAMP5
(Polytechnic University of Puerto Rico, 2016)it has been 29 years when Process Validation was created. Since then there has been a lot of creations of different types of validations. During the years there have been a lot of improvements in every validation ... -
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 ...