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Life Science companies, which trade in a regulated industry that is essentially risk-conscious, are cautious when assessing an enterprise-wide learning management system (LMS) to ensure that the system adheres to the requirements of EU Annex 11 and 21 CFR Part 11. However, few LMSs provide this functionality at several depths and in certain cases this is not found until after the system is purchased.
Life science companies are increasingly investing in holistic talent management systems (TMS), where learning management presents an important feature. However, the question that arises at this juncture is what exactly does FDA anticipate the company to validate?
Today, data integrity has become an important regulatory topic in quality management. It refers to the consistency and accuracy of stored data, and presents a major challenge to biotechnology and pharmaceutical companies that can either make or break the outcome of a specific product.
Clinigen Group is a global specialty pharmaceuticals and services company headquartered in Burton on Trent in the UK. Started in 2010 by CEO Peter George merging the companies Keats Healthcare, Clinigen and Clinigen Healthcare, the organisation now provides services in over 130 countries. As well as the UK, the company has offices in the US, Japan, Australia, South Africa and Singapore.
In clinical settings, POCT provides rapid diagnostic information to help make clinical decisions as early as possible in the care and treatment of patients.
Despite the complementary nature of the fluorescence lifetime technique, most users found this unsuitable because of the size, cost and complexity involved to operate the instrument. Although the cost of instruments has reduced considerably, including the size and complexity of operation, before the introduction of the new EasyLife-X system, some users were still wary of using the fluorescence lifetime technique.
In ratio fluorometric experiments a scanning monochromator is useful for investigating intracellular cation concentrations. This article describes the various benefits of using the scanning monochromator.