Emerging technologies are quickly playing a greater role in how the Pharmaceutical and Life Sciences Industry collects, stores and interprets its data. Mixed Reality platforms are becoming more widespread in the application of displaying andinterrogating this data. This paper summarises the trials of an initiative supported by KENX USA, TU Dublin and BioPharmaChem Ireland (BPCI). […]

The Food and Drug Administration (FDA) has recently proposed dramatic changes to the current Computerized System Validation (CSV) approach that is being used by most companies in the Life Science Industry. Although not yet released, the proposed Computer Software Assurance for Manufacturing, Operations, and Quality System (CSA) guidance will assist manufacturers overcome several barriers to […]

Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has very slow cloud adoption rate. One of the potential reasons for this phenomenon, as highlighted by GAMP Cloud Special Interest Group (SIG ) is the lack of regulatory and […]

In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater […]

A big reshuffle has been made in one of the principal guidelines for Commissioning & Qualification (C&Q) within the pharmaceutical industry today. The changes seek to improve the application of Quality Risk Management (QRM), a growing element of regulatory expectation. This research investigates the impact and implications of the changes to a key area of […]