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Consulting Company for Risk-based Quality Management, Quality Assurance, GxP-Compliance and Continuous Improvement of Processes, Data and Computerized Systems

We provide professional compliance services for pharmaceutical and medical device companies. We support start-up companies as well as SMEs and global corporations throughout the entire product lifecycle.

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Beratung, Unterstützung, Personal und Projekte
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Q-NEWS

Publication: ISPE GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and Data - Good eClinical Practice is out now!

This ISPE GAMP GPG on Compliant Systems in Clinical Research provides guidance on how to address the specific 21st-century challenges in the validation and operation of computerized systems in the GCP field. The Guide’s authors, including Q-FINITY’s Oliver Herrmann and Dr. Jenny Gebhardt, consider the increased number, complexity, cost and patient-centricity of clinical trials and focusses on the necessity of implementing a new model of a virtually integrated drug development process. This process needs to be supported by highly integrated computerized systems to collect, process and analyze clinical data, including everything from Statistical Programming Platforms, Data Capture Systems, and Interactive Response Technologies (IRT) solutions to Mobile applications for Electronic Patient Diaries and very soon wearables. The guide addresses all of these aspects, which pose a significant challenge for appropriate control by sponsors and all other stakeholders, such as CROs and technology providers

More Information: Order the ISPE GAMP Good Practice now

Publication: Pharma Technologie Journal - IT-Trends im GxP-Umfeld [IT trends in the GxP fields]

In this German-language publication, established experts from industry, consulting and suppliers provide insights into current trends and their practical implications in the GxP fields. Among the authors, Q-FINITY is represented  by Oliver Herrmann and Dr. Jenny Gebhardt ("Validierung von computergestützten GCP Systemen: Grundlagen, Ansätze, Herausforderungen und Trends" [Validation of computerized Systems: Basics, Approaches, Challenges and Trends]) and Dr. Stefan Schaaf ("Enterprise-Managementsysteme als Basis für GxP-Compliance in der Life-Science-Industrie" [Enterprise Management System as the Foundation for GxP compliance in the Life Sciences Industry]).

More information: Order this publication here ! - ISBN: 978-3-87193-302-8

ISPE GAMP D-A-CH News

Oliver Herrmann, CEO of Q-FINITY, will be replacing Dr. Heinrich Hambloch as Deputy Chair of the GAMP D-A-CH group and was introduced in his new role at the last GAMP D-A-CH meeting in Berlin.

 

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How deep should IT systems
be validated?
The GxP Fitness Check by Q-FINITY combines a compliance status audit, basic training, workshop and master planning to create an optimal basis for conducting upcoming IT validation projects in a risk-based manner and resource friendly (in accordance with the common standards such as GAMP, PIC/S). We do this on site and at an affordable price. request more information


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