The Journal of Validation Technology
Vol. 23, Issue 1, Feb 2017

Adam Tessneer
Lou Killian
Rick Mineo
A Case Study on Implementation of an electronic Solution for Validation Life Cycle Management resulting in Productivity improvements greater than 100% and Cycle Time improvements greater than 50%.
Eugenie Webster (Khlebnikova)
This paper discusses acceptance sampling by attributes and statistics involved in the application of ANSI ASQ Z1.4: Sampling Procedures and Tables for Inspection by Attributes. The paper focuses on how statistical formulas calculated using Microsoft Excel can be used to develop accept/reject criterion for a single sampling plan, how to compare...
John E. Lincoln
Data integrity is a recent concern for the medical products industries, a result of the increased reliance on electronic software, records and signatures, stand-alone or networked. Initially there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe. But more must be done to ensure the integrity of CGMP documents / records...
Drew N. Kelner
Ira S. Krull
Robert J. Duff
Tamer Eris
This installment delves into robustness considerations for HPLC methods and identity and validation design for peptides characterization methods.
Tara Scherder
Explore the concepts and some specific aspects of statistical intervals that must be understood to mitigate the risk of wrongly failing a PPQ batch. It also presents a tiered sampling strategy that could be implemented to not only avoid this situation, but also optimize sampling.
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