Structural Analysis
Structural Analysis

Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies

By Kim Ehman, Ph.D., Sandi Schaible, Sherry Parker, Ph.D.

Intensive chemistry requirements are creating massive data sets of chemicals, all of which need to be assessed for biological safety. This deluge of data is making equivocal results far more common than ever before. Fortunately, manufacturers can take steps to mitigate risk and support the safety of their products.

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Medtech, innovation
Medtech, innovation

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

By MedTech Intelligence Staff

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
Soapbox

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

By Romuald Braun

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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