SMART quality & compliance
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 example. Data Integrity in general Data Integrity is the maintenance and assurance of the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data Integrity in the GxP-Environment Data Integrity presents a major challenge to biotechnology and pharmaceutical companies as information needs to…
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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…
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SMART quality & compliance
15th DIA Conference on European Electronic Document Management
Two of our consultants recently represented KVALITO at the 15th DIA Conference on European Electronic Document Management, held on December 2-3 in Berlin, Germany. A wide range of interested parties attended the conference, from big pharma (Pfizer, Sanofi, Bristol-Meyers Squibb, GSK, Bayer, Novartis, Roche), health authorities (FDA, BfArM, Egyptian Ministry of Health, MHRA), providers and vendors, to hear new information about electronic document management in the area of clinical trials and pharmacovigilance. Key topics that emerged from the conference presentations and discussions included: Upcoming EU Clinical Trial Regulation: Discussion and presentation about the upcoming clinical trial regulation and its impact…
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