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Featured

Toon Lambrechts / Unsplash

Lessons From GAMP 5
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively. One notable exception is ISPE’s GAMP 5: “A risk-based approach to compliant GxP computerized systems.” More…

FDA Compliance

Preparing Your Quality System for AI-Enabled Asset Management

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

It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet.…

Manage Change

A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…

What Is an FDA Auditor Looking For?

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. Better still, you can also find a posted list of…

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

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

In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct…

Marked for Life

In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance. Because direct part marking plays a key role in ensuring traceability and unique device identification (UDI) conformity, it’s…

New NIST Reference Strengthens Quality Control for Biological Drugs

A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…

more articles
Bluestreak Launches Laboratory Information Management System
Bringing clarity, control, and compliance to laboratory operations
Stopping Recalls Before They Start
Advanced 3D laser scanning for food and medical packaging inspection
QuickVault by Veeva Launches Regulatory and Submission Management Functionality
Helps speed medtech approvals
82% of Physicians Question Safety and Quality of Medical Products They Prescribe
New study reveals declining confidence in regulators and an increase in medical misinformation
Rockwell Automation Launches PharmaSuite 12.00
Accelerates secure, scalable deployments
NAPT Announces Proficiency Testing Risk Analysis Module
No extra charge to the metrology community
IQVIA Named a Front-Runner in Generative AI Innovation
Report by industry research and analysis firm Everest Group
LabWare Launches ASSURE
New SaaS platform comprises food product safety, quality control, and regulatory compliance
MDIC Presents the Accelerate Sustainable Capability Pilot Study
Raising the bar for quality standards in medical devices
American Systems Registrar and Orion Registrar Rebrand to Amtivo in the US
Working to unify, simplify certifications
Olympus Presents VISERA S
New imaging platform supports patient comfort, improved diagnostics, streamlined workflow
more news

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