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…
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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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