Tag Archives: compliance

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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Structural Analysis

Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies

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

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

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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