Part II: Overview In the previous article, we discussed that AI has great potential to revolutionise the healthcare...
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Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (I)
Part I: Overview These days human life is touching Artificial Intelligence (AI) in one way or the other, for example,...
Computerised System Validation vs Computer Software Assurance by the Example of ERP System Validation
The pharmaceutical, biotech, and medical device industries are subject to strict health authority regulations to...
Better Prepared with a Health Check?
CC BY-SA 3.0 NY "By failing to prepare, you are preparing to fail". – Benjamin Franklin FDA published an announcement...
Patient Safety First – A New EU Directive to Protect Public Health from Falsified Medicines
“It is health that is real wealth and not pieces of gold and silver.” Mahatma Gandhi Imagine you have a bacterial...
GMP for Excipients
GMP for Excipients Version Infographic
Keeping Up with Digital Trends
“Enterprise architecture and technology innovation leaders using enterprise architecture to master emerging and...
Your computerized Medical Device is 5 years old, outdated and possibly evil
Do you remember the hacked Hospira infusion pump in 2015, which was a big story in the news and forced an FDA product...
eMDR (Electronic Medical Device Reporting)
Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21,...
The Medical Internet of Things Is Here and It Must Be Secured
Security is like the brakes in your car. It slows you down, but it also makes it possible for you to go a lot faster....
Eight Critical Success Factors to be considered in Times of Organizational Change and Transformation in Regulated Environment (Practical View)
"The Only Thing That Is Constant Is Change" (Heraclitus) In today's globalized and fast-changing world, it is very...
Top Four Mistakes to Avoid When Validating a GxP-Classified Computerized System
“An investment in knowledge pays the best interest.” –Benjamin Franklin Introduction Computerized system validation is...