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 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
Brexit and its impact on Pharma Compliance
The definite impact of Brexit on the Pharma Industry is, for the moment, vague. What is clear though, is that Brexit will have a big impact on the pharma supply chain and pharma compliance bodies. Due to Brexit the EMA must move to a new location, which is Amsterdam. All pharma compliance bodies which need to sit in an EU-country need to also move e.g.: QP, QPPV, Regulatory Affairs, etc. One advantage is, that after Brexit, the MHRA is only allowed to do inspections for medicines sold on the UK market like the FDA. It will be a long process…
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SMART quality & compliance
How to validate an autonomous self-patching system?
In 2016, the Defense Advanced Research Projects Agency (DARPA) of the United States Department of Defense organized the Cyber Grand Challenge. At this event, fully, autonomous systems with no human interaction attacked each other, but also developed patches for their own vulnerabilities. This event was carried out under lab conditions (simple operating system with few system calls, no file storage, exploiting and patching only via an interface to a central adjudicator system). It gave an outlook into the future of Information Technology as a whole, mostly in IT-Security and Validation. In future, we will see cyber-attacks run completely by Artificial…
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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
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
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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SMART quality & compliance
Top Four Mistakes to Avoid When Validating a GxP-Classified Computerized System
“An investment in knowledge pays the best interest.” –Benjamin Franklin Introduction Computerized system validation is a process and shall be followed the entire system life cycle. The validation of a computerized system starts often with a project and ends with its retirement. When validating a GxP-classified computerized system four typical mistakes shall be avoid which cause unnecessary cost. 1) Defining scope and starting validation strategy and planning at the very end The most important is to know what business wants and therefore what the scope is as all validation efforts will…
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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…
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SMART quality & compliance
Good Distribution Practice: Brief Overview
“In theory there is no difference between theory and practice. In practice there is.” – Yogi Berra Good distribution practice, also known as GDP, was originated by the World Health Organisation (WHO) and the European Economic Community. It was written as a set of guidelines for the pharmaceutical suppliers. Today these guidelines are issued by various regulatory bodies. Who is responsible for GDP and why is it important? The marketing authorisation holder is responsible for GDP which is useful for prevent and guarding against risks that can cause dire consequences through standards of practice. The WHO describes GDP as…
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