12 ANALYTICAL AND LABORATORY EQUIPMENT
The connected laboratory I
Informatics infrastructure enables the fully integrated pharmaceutical laboratory. Trish Meek reports.
L’infrastructure informatique rend possible le laboratoire pharmaceutique entièrement intégré. Trish Meek fait son compte-rendu.
Eine IT-Infrastruktur ermöglicht das voll integrierte pharmazeutische Labor. Trish Meek berichtet.
n a 2013 report, Gartner analyst Michael Shanler advises that manufacturers
‘prioritise end-to-end informatics investments and align metrics for innovation, domain expertise, operational efficiencies and quality’. His recommendation is based on an observation that today’s laboratories ‘are, for the most part, disconnected’.
Te move to a connected laboratory is driven by the productivity objectives Shanler outlines—but also by significant technology improvements. Te paperless lab has been discussed for the past 20 years, but it is finally materialising.
LIMS/LES/SDMS enables lab managers to achieve full instrument integration, manage their methods and workflows.
Nowhere is this more evident than in pharmaceutical quality assurance/quality control (QA/
QC) laboratories. Few QA/QC lab techs still record their data by hand; but, while this is a critical step, it is only the first step in a bigger overhaul process. Tere’s far more to becoming a paperless lab than simply eschewing paper.
Labs must adopt a smart infrastructure that drives quality, not only in the lab, but throughout the organisation. An integrated informatics solution is the engine that drives quality product release and a culture of continual process improvement.
Quality by Design In 2004, the FDA introduced Quality by Design (QbD) in ‘Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach’. While this concept is not new to many industries,
this was the first attempt to apply these principles to the pharmaceutical industry. Quality by Design is built on the concept that well-understood products and processes are more efficient and produce higher quality products resulting in less product nonconformance.
Te FDA’s goal was to improve pharmaceutical companies’ productivity, to ensure patient safety and to prevent drug shortages in the marketplace. Uncompromising quality is essential to any pharmaceutical company. Informatics plays a critical role in ensuring that organisations realise the improved product quality and operational efficiency that adherence to QbD principles provides.
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