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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...
Medical Device Legislation in the European Union – Revision of Current Framework including Unique Device Identification (UDI) Regulation is Coming Soon?
If you place a medical device on the market your company must comply with the relevant legislation and corresponding...
Cloud-Sicherheit in der regulierten Life-Science-Industrie
Die Sicherheit von Cloud-Lösungen ist ein wichtiges Thema in nahezu allen Wirtschaftsbereichen, jedoch gelten für die...
FDA approves first ever 3D Printed Drug
The FDA has approved the first ever drug created via 3D Printing technology, a decision which can lead to a new era of...
Data Privacy In The Age Of Digital Health
What do you think is the most valuable asset of every patient in the world? The thinking behind this question is...
Compliance für die Gesundheit 2.1
Durch neue technische Entwicklungen wird der Traum von der personalisierten Medizin langsam aber stetig Wirklichkeit....
A Master Data and IDMP Compliance DEADLINE!
Author: KVALITO Consulting Group
Stricter… Harsher… Narrower…? GMP guide improvement of best practices in the area of Quality
The pharmaceutical industry is a highly regulated and controlled sector of economy. Development, manufacturing, and...
The clock is ticking! From planning to execution: e-pedigree and serialization
“The price of no action is far greater than the cost of a mistake” ― Meg Whitman FDA regulations State governments,...
Do It Better And Faster – Batch Management & Global Batch Traceability
"Quality is everyone's responsibility" - W. Edwards Deming Batch: Material or Product Quantity with similar...