The Journal of Validation Technology
Vol. 24, Issue 3, Jun 2018

Let's take a look at what is ahead in this issue - a lot on inspection readiness and a lot of answers to your questions! Read on and get in touch with us. You're invited to collaborate with us!
Aris Koumandaros
This paper presents an overview of data integrity, defining the requirements for data reliability, providing a description of data-related issues, potential root causes, and US Food and Drug (FDA) regulatory requirements.
Alan M. Mancini
Paul L. Pluta
The following is part of the Compliance in Quality and Validation (CQV) series which presents real-life stories reflecting compliance problems in the pharmaceutical, medical device, and related industries.
Alice Krumenaker
In an FDA regulated industry, routine inspections occur on a regular basis. Because of the important role quality control laboratories play in the testing and release of products, they are often an area of focus during FDA inspections.
Amjad Ganma
What is risk and how do we begin to implement quality risk management systems? This paper illustrates the fundamentals of QRM and helps to adopt an action plan that keeps in mind potential threats.
Paul L. Pluta
The site VMP is a critical document. Early review of the VMP by regulatory auditors often sets the tone for the remaining days of inspection. A thorough and well-designed VMP demonstrates a well-run facility.
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