Welcome to the April 2018 issue of Journal of Validation Technology! Now in its 24th year of publication, JVT has a proud history and tradition of providing valuable lead-edge information and perspectives to major industry topics. Our journals were originally conceived by a small group of scientists seeking answers to everyday validation problems...
IVT Ken Chapman Award winner, Cliff Campbell, remembers the late validation pioneer, Ken Chapman. The process validation fundamentals that Chapman developed are explored.
ENGINEERING CASE STUDY: In this JVT Special Feature, industry experts introduce a new, automated process that provides a compliant, productive, simplified ASTM E2500 methodology. Learn more about this exciting new technology.
Cybersecurity threats are a clear and present danger that looms over every company no matter what the size. Compromise, destruction or theft of data held within validated systems can inflict significant damage or result in significant non-compliance violations.
Due to the significant number of guidance documents published by regulatory agencies and high volume of related observations data integrity has become a very hot topic for the pharmaceutical industry.
In recent years standards-setting organizations such as the United States Pharmacopoeial Convention, ASTM International, and the International Organization for Standardization (ISO) have created guidance on how to detect and designate outliers in sets of measured values. These are compared.
The success of data governance education is significantly influenced by the relationship training and development has with senior management and data stewards.