Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy. Take patient data of clinical studies, for...
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How to validate an autonomous self-patching system?
In 2016, the Defense Advanced Research Projects Agency (DARPA) of the United States Department of Defense organized the Cyber Grand Challenge. At this event, fully, autonomous systems with no human interaction attacked each other...
Sponsored by KVALITO – HBA Connect: It’s All About Networking and Lipstick Leaders
A casual get together to celebrate International Women's Day and connect with peers. The highlight of the evening will be the presentation of the "Lipstick Leaders" project by the artist Daniel Eisenhut, "What is Woman Leadership? Is...
Keeping Up with Digital Trends
“Enterprise architecture and technology innovation leaders using enterprise architecture to master emerging and strategic trends must plan for a radical, long-term (2020 to 2025) evolution of the user experience for both customers 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Your computerized Medical Device is 5 years old, outdated and possibly evil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 recall? A laptop with applicable software was connected to the maintenance port, which was an Ethernet Network port, of...
eMDR (Electronic Medical Device Reporting)
Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010), which demands registration of any medical devices, which meets the definition of a medical device before starting...
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. (Gary Hinson) On the Chaos Communication Congress in December 2015 in Hamburg, Germany, there was a talk about medical...
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 common that life science companies around the globe not only buy and sell entire subsidiaries but also single parts of...
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 a process and shall be followed the entire system life cycle. The validation of a computerized system starts often with...
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 processes. In order to gain access in Europe your company must follow the current European Commission framework which is...
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 Life-Science-Industrie hier besondere Anforderungen, da dieser Wirtschaftszweig Patientendaten und geistiges Eigentum...
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 drug manufacturing. The drug controls seizures called Spritam, manufactured by Aprecia Pharmaceuticals. FDA have also...
Sponsored by KVALITO Scenario Planning – How to Think Differently About the Future
Event description As leaders and managers, you are feeling the constant pressure of global competition and unrelenting changes that are taking place in your business landscape. Your challenge is a difficult one: to formulate strategies...
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 shown in the implementation of digital health functions and solutions in the company and its products. The most valuable...
Compliance für die Gesundheit 2.1
Durch neue technische Entwicklungen wird der Traum von der personalisierten Medizin langsam aber stetig Wirklichkeit. Themen wie Digital Health und Industrie 4.0 spielen hier eine wichtige Rolle, denn erst durch die Vernetzung beider...
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 management of medical products are carefully examined and analyzed in order to ensure amenability with present...
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, federal agencies and the pharmaceutical industry started a real war against counterfeiting and diversion. Track and trace...
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 characteristics Global Batch Traceability (GBT) is a SAP application, which operates across various systems and products. It...
Keep Calm and Stay Patient… So Much More Is Coming! -“FDA and the Drug Quality and Security Act”
“Companies spend millions of dollars on firewalls, encryption and secure access devices, and it’s money wasted, because none of these measures address the weakest link in the security chain". – Kevin Mitnick ...
