Have you ever thought about what is the ‘fil rouge’ that connects all regulations applicable to the pharmaceutical...
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Theranostics: The Future of Precision Medicine
The term "theranostics" is a combination of "therapy" and "diagnostics"; it is an emerging field that combines into a...
How Web and Mobile Applications as Medical Devices are Transforming Healthcare Delivery: Trends and Predictions
Introduction Mobile Health (M-Health) technology, using mobile devices like smartphones and tablets, has been rapidly...
What’s the difference between a Regulation and a Directive?
A regulation shall be applied in its integrality in all the European Union. Unless a directive sets out an objective...
How to Increase Quality Through Risk-Based Business Process Mapping
Introduction Nowadays, more and more companies are starting to grow and lose visibility of the organization’s global...
FDA Forced to Evolve its Toolkit Amidst Mounting Inspection Backlog during the COVID-19 Pandemic
Impact of COVID-19 on FDA Inspections The COVID-19 pandemic profoundly disrupted the FDA's inspection...
Top 5 GxP Controls
The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To...
Can the Use of Unlicensed Font on your Website, Marketing Materials, or Packaging amount to a Copyright Breach?
"Type designers are, at their best, the Stradivari of literature: not merely makers of saleable products,...
What is and what is not a Software as Medical Device (SaMD)?
The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the...
Agile and Scrum in GxP Environments – How does it Work in Practice?
“Intelligence is the ability to adapt to change.” (Stephen Hawking) Introduction To date, classical methodologies,...
Precision Medicine
Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel...
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...