Medtech, innovation
Medtech, innovation

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

By MedTech Intelligence Staff
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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
Romuald Braun, Amplexor
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Smart IDMP: How to Ensure Preparations for ‘Data-Driven’ Future Are a One-Time Investment

By Romuald Braun
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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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