SMART quality & compliance
Block Chain Technology and the Pharmaceutical Industry – A good fit?
“Undoubtedly, it’s best applications are yet to come.” Alex & Don Tapscott on the Blockchain technology in “Blockchain Revolution” Picture Source: https://media.licdn.com/mpr/mpr/AAEAAQAAAAAAAAyNAAAAJGYyOTRjN2Q4LTA3ZjctNGU2Ny04NWYyLWRjNDA2YzljNjdlNw.jpg, 21.06.2017, 15:42 Uhr Blockchain – what it is and why it is the technology of the future? Blockchain is the technology of the future: With its decentralized database structure, providing the user with yet unprecedented data security and integrity standards by maintaining data records which are tampering-resistant, the blockchain methodology has already conquered the finance sector with the invention of bitcoin. But this technology is much more than its first implementation as part of the cryptocurrency bitcoin would suggest: it is…
Read More >
SMART quality & compliance
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 in August 2016 to focus on part 11 inspections in near future. The future is now. Project tollgates, health checks, periodic reviews, assessments, audits, real time monitoring. What is the best way to always be prepared and ready for Health Authority inspections? Computerized systems and projects vary in size and complexity ranging from few users by supporting a simple business process to thousands of users supporting multiple business processes. Furthermore, projects can range from single location to a global rollout…
Read More >
SMART quality & compliance
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 employees as conversational systems, augmented reality (AR), virtual reality (VR) and continuous/contextual user experiences radically change the way people interact with systems.” Gartner, 14 October 2016 Report. Picture this: presently, a digital stethoscope with the ability record and store data such as heartbeat and respiratory sounds. Tomorrow, the same stethoscope could function as an “intelligent device” by collecting massive amounts of the same data, correlating it with diagnostic…
Read More >
SMART quality & compliance
Your computerized Medical Device is 5 years old, outdated and possibly evil
“With the rise of the Internet of things, one part of IT becomes more important where no one thinks about it. – Firmware” Florian Schnettelker Do you remember the hacked Hospira infusion pump in 2015, which was a big story in the news and forced a FDA product recall? A laptop with applicable software was connected to the maintenance port, which was an Ethernet Network port, of this pump and the hacker got soon access to the medical library of this pump and also the Wi-Fi credentials of internal hospital network. But how and why did this happen?…
Read More >
SMART news
2016 – 3 years KVALITO Consulting Group!
“Every journey of a thousand miles begins with a single step.” (Lao Tzu) Please join us in celebrating this milestone which started three years ago as a great journey. We must be proud of what we have achieved since June 2013. We started as a little team with one corporate client in Switzerland, and based on excellence and our clients trust we continued our journey in 2014 with our offices in the Czech Republic and Germany and last year with our office in Ireland adding several more corporate clients, small and medium-sized enterprises as well as start-ups. We as a…
Read More >
SMART quality & compliance
Data Privacy In The Age Of Digital Health
“Without privacy there is no trust, which is what the best individual healthcare requires” – Florian Schnettelker 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 asset for a patient is his/her personal health data. This topic becomes more and more important with the rise of digital health solutions in our daily personal and business life. Laws and Regulations In many countries there are laws and regulations issued in…
Read More >
SMART quality & compliance
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 Bereiche entsteht eine individuelle und kosteneffektive Medizin. Weitere Punkte, die hier hinein spielen, sind der wachsende Kostendruck im Gesundheitswesen, den verschiedenste Regierungen in den Griff zu bekommen versuchen, und gestiegene Compliance-Anforderungen. Ein Beispiel dafür, wie die verschiedenen Faktoren mit einander interagieren, sei nun im Folgenden erwähnt: Ein implantierter Sensor erkennt im Blut eines Patienten auffällige Werte. Diese Werte werden per Funk über das Internet an den behandelnden…
Read More >
SMART quality & compliance
A Master Data and IDMP Compliance DEADLINE!
Lead Author: Tanja Rohark Would you like an update everytime we write a blog post? Subscribe here! * indicates required Full Name * Email Address * Company Work Position
Read More >
SMART quality & compliance
Implemention a Smart Quality Management System
– “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” ~William A. Foster Implement A Quality Management System Effectively and Efficiently Today’s fast changing business environment demands from a company increased flexibility, openness and security. Stakeholders expect transparency, highest quality and compliance ensuring product quality, patient safety and data integrity. In fact, companies operate in a highly competitive environment, which ruthlessly challenges their activities. Businesses need to stay ahead of the opposition. In order to achieve it, they must deliver products…
Read More >