SMART events
You’re invited! Data Integrity Workshop in Barcelona, Spain – March 01, 2019
If you would like to join this Data Integrity Workshop, you can get your ticket via Eventbrite or send us an e-mail: julia.lopez_guimet@kvalito.ch. Please note that participation is limited to 30 We are looking forward to meeting you in Barcelona!
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SMART quality & compliance
GDPR- Changes in Data Privacy Protection Affects Multinational Businesses
This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46 EC. The GDPR is a complex piece of legislation comprising 11 chapters, 99 articles and 173 recitals. The aim of the GDPR is the protection of the data privacy of each individual (data subject). In short, the protection against abusive data processing, the protection of the right to informational self-determination, the protection of personal rights in data processing, as well as privacy protection must be ensured to be compliant with GDPR. The following article…
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SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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SMART quality & compliance
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 devices with new functions like a Bluetooth connection by a pacemaker to connect them to smartphones or a gateway for telemedicine. But with each connection to the outside world, a device becomes vulnerable which must be secured in a way that this connection cannot be used to harm patients. Last year the FDA pronounced a recall…
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