The Journal of Validation Technology
Vol. 21, Issue 3, Oct 2015

What constitutes a data integrity issue? Which data is critical? Should we take a risk based approach? This article will provide answers to these challenging questions and solutions about how to perform regularly audit trail reviews.
Joseph Wood
Duncan Chadly
Thomas W. Patapoff
Terry Hudson
Adeyma Arroyo
In this study, the root cause of a staining phenomenon observed during cleaning studies performed using a specific lot of ethylene propylene diene monomer (EPDM) rubber coupons was investigated. Scanning electron microscopy and stereomicroscopy were employed to understand the mechanism of staining. Results suggest stains were artifacts of the...
Tim Sandle
This paper discusses the MALDI-TOF technology and outlines the advantages and disadvantages with the system. Microbial identification plays an important role in pharmaceutical processing. Microbial identification can be defined as "microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being...
One of validation biggest challenges is relying in paper based processes. Paper based validation is very costly and inefficient. Electronic document management systems sometimes appear to be an adequate solution, but they have their own challenges.
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