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Four Scary Life Science Quality Management Stories
100% real, 100% anonymized, 100% scary
FDA Inspections on the Rise
Consulting the FDA’s Case for Quality program
In Pursuit of Quality Excellence
Four data layers that matter
Report Details Conveying Systems in Food and Beverage Industry
The Food and Beverage Industry 2023 State of Conveying on industry trends, top concerns, objectives
The Importance of a Document Management System
Without it, manufacturers face risks of recalls, compliance issues, and lower productivity
The Ultimate Guide to ISO 14155:2020 for Medical Devices
Understanding the standard is essential
Risk Management in ISO 13485
The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Validation Life Cycle Management Speeds Auditing, Facilitates Regulatory Inspections
An excellent technological tool that improves quality and compliance
Health Systems Need More Insight Into Inventory, Supply Chain
Amid rising prices, medical device supply chains need greater scrutiny and standardization
Tiny Magnetic Beads Could Help to Quickly Detect Pathogens
Findings point to faster way to find bacteria in food, water, and clinical samples
Build Your Culture of Quality With These Four Foundational Principles of Quality 4.0
Take this opportunity to prepare for the future
What FDA QSR and ISO 13485 Harmonization Means
QMSR for medical device companies
Five Necessary Steps to Maintain a Reliable CAPA Process
CAPA systems require continuous management, effectiveness checks, and support
Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry
The answers will reveal the truth about your product and get it to market faster
Linking Design Controls and Risk Management in the QMS
Automation maintains a living document and integrates risk management
Embracing AI-Driven Technology to Augment Quality and Regulatory Activities
The benefits of AI in healthcare have been identified by many global regulators
Studying Food Safety Through Measurement
Whatever you eat, NIST is working to keep it safe
Overcoming Blockers to Digital Quality Management
Don’t wait until something bad happens to make a change
How a Purpose-Built eQMS Improves Compliance in Life Science Organizations
A lack of integration hampers quality compliance across a product’s life cycle
Five Foundational Steps of a CAPA Quality Process
A well-defined CAPA program is a framework for quality and effectiveness

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