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Big Food Is Ripe for a Revolution
The wine industry shows how eco-friendly production can benefit both companies and consumers
Six Ways to Improve Product Quality in Food Manufacturing
A crucial method for differentiation (and profitability) in a tight market
Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance
A tardy response will be costly and painful
Transforming Quality Operational Data Into Business Insights
Data-driven decisions are only as good as the data that drive them
Global Regulatory Harmonization
How manufacturers can best prepare as the FDA moves to adopt ISO 13485:2016
FDA to Sunset Alternative Summary Reporting Program
The agency seeks to balance expedient exemptions against public transparency about medical devices
Will New EU Medical Device Regulation Hit Tongue Depressors Before Defibrillators?
European MDR update: Lowest risk medical devices must comply by May 26, 2020
Eliminating the Digital Divide in Life Sciences, Part 3: The Truth About Cloud Security
Three-quarters of life sciences CIOs and IT execs say security risks are main reason for opposing cloud technologies
Eight Things You Need to Know About the European Medical Device Regulation
Setting up for long-term success
What to Make of FDA’s Secret Cache of Device Adverse Events
Questions linger about FDA processes that seem to favor medical device companies
Eliminating the Digital Divide in Life Sciences, Part 2
Confronting the fear of being displaced by machines
Eliminating the Digital Divide in Life Sciences, Part 1: Compliance Concerns
The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry
Big Data: Your Health vs. Your Privacy
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.
Ensuring Food Safety With Quality Management Software
A cloud-based QMS can help address common international standards and regulations
Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
Particularly in regulated industries, you really do want to know what goes into the sausage
Power Moves: Turning Compliance Into True Quality
A primer for life science manufacturers
Life Science Regulations, Compliance, and the Move Toward QMS Software
A timeline of FDA and Sparta System activities
FDA Milestones
Easing regulatory compliance
Taking a Risk-Based Approach to Drug Inspections
A concise history of FDA’s risk-based Site Selection Model
Proactive Processes in High-Reliability Organizations
What can we learn from the organizational cultures of different industries?

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