The fourth revolution has already occurred in manufacturing. Industry 4.0 is a fact, and the different industries must focus on adapting the new technologies in their processes. The new technology revolution will and has indeed already affected businesses. Take a look at its impact on the...
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The sustainable environment is a subject under consideration for all participants in the supply chain for a long time. We outlined the key first “green steps” from the Pharma industry in our free whitepaper. They could be the beginning of the road towards environmentally friendly manufacturing...
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When we mention the topic “traceability”, the term “visibility” comes automatically in our minds It`s normal because the idea behind the implementation of track & trace systems is to be achieved a real-time view of the supply chain, by which the route of the products could...
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What were the expectations of serialization? What did happen in reality? We have discussed serialization`s challenges before and we could definitely say that because of their diverse nature and different level of difficulty, the individual supply chain participants adapt and deal with them in various ways....
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Yes, traceability is a “must” nowadays. In recent years people and industries have put trust in track and trace systems for the good of the whole supply chain. The definition for traceability is simple – the process of tracking the origin and the whole way of...
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"There are no plans to extend the 2023 deadline for enforcing the interoperability requirements" said Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research. The US Food and Drug Administration is working “full tilt” towards implementing...
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The International Coalition of Medicines Regulatory Authorities (ICMRA) released a report which provides technical recommendations, strongly focused on interoperability. The document is drawn up by the ICMRA in cooperation with WHO (World Health Organization). The referred recommendations are continuation of ICMRA`s 2017 paper, which analyzed...
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EU MDR`s impact on legacy medical devices Medical Devices Regulation (MDR) completely changes the legislation and business processes regarding the production and distribution of medical devices. We have already considered the topic of MDR`s changes and requirements, but not the impact on the legacy medical devices. In...
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How to evaluate a cloud service provider? Cloud services are not already a “tabu” for the pharma industry. In fact, despite the established notion that the pharmaceuticals prefer services and solutions that are on-premises, nowadays they are strongly focused on using new technologies. The innovative solutions...
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The widespread development of technology, together with the effects of the pandemic, has drastically changed the behavior of the pharmaceutical industry. According to a recent survey, we’ve conducted, 67% of pharmaceutical companies had to shift their plans for digital transformation in 2020 due to the COVID...
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