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Lessons From GAMP 5

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Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms.

Preparing Your Quality System for AI-Enabled Asset Management

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What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

Manage Change

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A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety.

What Is an FDA Auditor Looking For?

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Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam.

AI ‘Co-Pilot’ Can Reduce Prescription Errors That Put Patients at Risk

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Take two aspirin and call me in the morning: If only prescribing medications were as simple as that.

Marked for Life

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Lasers enable safe, scratch-resistant marking that’s more durable than ever.

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In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance.

New NIST Reference Strengthens Quality Control for Biological Drugs

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A team of NIST researchers, including Srivalli Telikepalli (shown here), developed a standard reference material that will help biopharmaceutical companies better detect these particles in their drug products.

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A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders.

Pharmaceutical Serialization

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Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina.

Carrying Out a Supplier Audit

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Good supplier management is one of the most important methods of building a safe and effective medical device.

5 Key Elements of an Effective CAPA System

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The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS).

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