SMART events
You’re invited! Data Integrity Breakfast
When? November 21, 2017, 8:30 AM Where? KVALITO HQ, Dornacherstrasse 101 4053 Basel – CH Agenda: 8.30 AM – 9.10 AM Networking & French Breakfast Sponsored by KVALITO 9:10 AM – 9:15 AM Welcome & Introduction Magdalena Kurpierz (CEO & Founder, KVALITO) 9:15 AM – 9:45 AM Data Integrity – Regulatory Background Anne Woitzik (Life Science Consultant, Data Integrity, KVALITO) 10:00 AM – 10:45 AM Real world data integrity case Anne Woitzik (Life Science Consultant, Data Integrity, KVALITO) 10:45 AM – 11:00 AM Q&A, Wrap-Up and Quiz (including prize) Anne Woitzik (Life Science Consultant, Data Integrity, KVALITO) …
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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…
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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Your computerized Medical Device is 5 years old, outdated and possibly evil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?…
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SMART quality & compliance
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 schützen muss. Denn wie auch in einem anderen Artikel in diesem Blog (Data Privacy in the Age of Digital Health) erwähnt, zählen die persönlichen Gesundheitsdaten eines Patienten zu den sensibelsten Daten, die es gibt. Ein durchschnittlicher Angestellter in einem Großunternehmen in den USA verwendet 27 Cloud-Dienste, da diese häufig für das Business einfach einzurichten sind. Das führt jedoch zu erhöhten Gefahren und einer wachsenden Schatten-IT. In einem Großunternehmen in den USA werden im…
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SMART quality & compliance
GxP Compliance: Back To Basics
“Make it right today, better tomorrow”. -F. Schnettelker If a drug is being produced in a GxP compliant manner, there are various specific guidelines that must be adhered to. In principle, computer systems associated with the life cycle of a product must meet certain criteria. The pharmaceutical industry must follow certain rules: Secure logging All system activities related to research, development and manufacturing must be registered by the users. This logged data cannot be amended, even by the admin responsible. Auditing Reconstruction of decisions and potential mistakes made in the development and manufacturing of a regulated product must be documented…
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SMART quality & compliance
Digital Health Compliance
“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You may have heard a friend talk about it, heard something on the news, or even downloaded an app. Whatever it is, digital healthcare is becoming the IT thing. More and more digital health applications are installed on smartphones, a number that is foreseen to grow exponentially. The United States alone is investing some 1.6 billion dollars…
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SMART quality & compliance
Data Integrity
If you are in the pharmaceutical or in the medical devices industry and cannot sleep at night that may very well be due to a lack of confidence in the integrity of the data of your company or your contract partners such as laboratories and manufacturers. If you are in the industry and are not concerned it might still not be a good sign. As a matter of fact, many companies apparently ignored the risks that lurked within their and their vendors’ systems and processes. Now they have to take the responsibility. Significant reputational damage, import bans, and the immense…
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