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!
Read More >
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…
Read More >
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…
Read More >
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) …
Read More >
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…
Read More >
SMART quality & compliance
A Master Data and IDMP Compliance DEADLINE!
Lead Author: Tanja Rohark Would you like an update everytime we write a blog post? Subscribe here! * indicates required Full Name * Email Address * Company Work Position
Read More >
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…
Read More >
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…
Read More >
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…
Read More >