Tag Archives: data

Sinisa Belina, Amplexor
Soapbox

Beyond Compliance: The Business Case for Smart, Real-Time Quality Monitoring in Life Sciences Manufacturing

By Siniša Belina
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Sinisa Belina, Amplexor

The pandemic put unprecedented pressure on drug and medical device production, underlining the growing challenge of monitoring, analyzing, reporting and acting on quality. It became clearer than ever before that the more fragmented processes become, the more critical it is that they can be assessed and managed for consistent quality. At the same time, innovative tools and best practices have emerged.

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Emily Newton, Revolutionized Magazine
MEDdesign

How Is the Digital Transformation Making Medical Manufacturers More Agile?

By Emily Newton
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Emily Newton, Revolutionized Magazine

Growing pressure on the manufacturing industry from rising prices, new regulations and supply chain uncertainty have accelerated medtech’s digital transformation. COVID-19, in particular, has encouraged medical manufacturers to adopt more resilient and agile working practices. New technology can enable process changes and business strategies that help medical manufacturers become more flexible and responsive to changing…

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Medtech, innovation

Why Documents and Data Can No Longer Be Treated as Distinct Entities

By MedTech Intelligence Staff
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Medtech, innovation

If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.

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Romuald Braun, Amplexor
Soapbox

Smart IDMP: How to Ensure Preparations for ‘Data-Driven’ Future Are a One-Time Investment

By Romuald Braun
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Romuald Braun, Amplexor

EMA’s IDMP is not the pinnacle of data-based product/regulatory information management. It is simply the first in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. This article reviews best practices for companies looking to maximize the ROI of their data-driven process transformation initiatives by making them more broadly fit for the future.

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