The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To address this, GxP was established and its compliance is mandatory in the healthcare environment. The GxP is a generic...
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KVALITO Consulting
So long Jasmine, wishing you all the best!
So long Jasmine, we wish you all the very best! Jasmine Lee recently graduated with her PhD in Medical Biochemistry. She has been a great asset to our clients and our team, and we will surely miss her! Jasmine's positive can-do attitude...
Business Case: Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends to publish a new guideline in the Fiscal Year 2021 (FY 2021) [R1]; "Computer Software Assurance (CSA) for Manufacturing,...
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, but artists who design and make the instruments that other artists use." ― Robert Bringhurst A...
AHK Malaysia
Over 60% of the global population is located in the APAC region, which is emerging as a considerable commercial opportunity for biopharma, pharmaceutical, medical device, and healthcare companies. With ongoing reform to healthcare systems...
New Microbiology Laboratory
In the pharmaceutical industry, ensuring compliance with regulatory requirements is of the utmost importance. Laboratory Equipment Validation (LEV) is a key aspect of this compliance, as it verifies that equipment and systems in the...
Untapped Potential
Rapid changes in employment trends, propelled by digital transformation; as our roles and responsibilities change, so must our working models. Take a look at KVALITO's flexible approach in placing highly skilled workers to client projects...
Data Integrity- where GxP, IT-Security and Data Privacy come together
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...
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...
