The Journal of Validation Technology
Vol. 26, Issue 4, Aug 2020

Barry McManus
The focus of IT ecosystems protection and monitoring reflects the discussions with IT departments on data integrity and security. The same discussion may have been neglected when it came to software. This paper discussed the defensive approach to building software for computerised systems and briefly discussed some of the techniques and processes...
Martin J. Lipa, Kevin O’Donnell, and Anne Greene
Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice. This paper presents a two-part literature review on this topic. First is a review of how other...
Kim Huynh-Ba
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Laure L. Larkin
Scientists and regulators have warned the industry about the importance of creating a Disaster Plan for over three decades. We have experienced industry disruptive weather events like Hurricanes Katrina and Maria, geological events including Fukushima, industrial accidents like Deep Water Horizon and Chernobyl, and now a global pandemic like COVID...
Paul L. Pluta
Validation Case Studies and Compliance Case Studies are ongoing features in the Journal of Validation Technology (JVT) and Journal of GxP Compliance (JGXP), respectively. These features have provided a forum for validation and compliance professionals to discuss their actual work experiences – problems and solutions that may be helpful...
Allan Marinelli
There are many methods or ways of writing a Validation Plan with respect to information technology platforms/software, relational database management systems, electronic document management systems, enterprise resource planning (ERP) for cloud-based software systems, and related items.  This paper discusses fundamental elements by...
Nadia Esani and Joseph Brennan
The outbreak of the coronavirus disease (COVID-19) and the subsequent announcement of a global pandemic in March 2020 has profoundly altered the working day routines of many people. This paper explores how aspects of normal daily working life for the regulatory professional have changed from the pre-pandemic to how it may look post-COVID-19, and...
Cliff Campbell
This paper introduces and discusses the concept of intrinsic compliance as an enabler of accelerated and economical qualification/validation. It utilises rudimentary set theory in support of this objective. It also defines a number of technical terms, including process parts, facility counterparts, composite objects, relational data, risk flags,...
Yeleiny Machin, et. al.
The recombinant human interferon α2b (rec-hIFNα2b) is used to treat cancer and viral infections such as SARS-CoV-2. The rec-hIFNα2b quantification immunoassay uses as main biological reagent the CBIFNα2.3 monoclonal antibody (mAb). However, this mAb recognizes a conformational epitope on rec-hIFNα2...
Cliff Campbell
In this episode, Stacey and Cliff speak about new ways of thinking across the industry that aim to ensure appropriate, risk-based, least burdensome validation, with a focus of validation activities, instead of the traditional "are we compliant?" mentality.
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