Here you will find an overview of the publications and papers in which QFINITY employees have been significantly involved. Several of these publications are considered standard works in the industry and influence the day-to-day work of the industry.
GAMP Good Practice Guide: Computer GCP Systems and Data 2nd Edition
The ISPE has just published the second edition of the GAMP Guide to Good Practice for Validation and Compliance of Computerized Clinical Systems and Data. More than 50 industry experts, including QFINITY experts, have worked on the second edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and data currently available.
The update to the first edition, which was published in 2017, was necessary as significant progress has been made in the conduct of clinical trials in recent years. Some of these changes, such as decentralized clinical trials, have been accelerated by the COVID-19 pandemic. The changes in the industry have also prompted regulators to issue guidance such as the EMA’s “Guideline on computerized systems and electronic data in clinical trials” and the “Notice to sponsors on the validation and qualification of computerized systems for clinical trials”, which have been taken into account when updating the guide. The content was also significantly expanded to include information on real world data / real world evidence, data protection in clinical trials, artificial intelligence and data science, and decentralized clinical trials. Last but not least, the guideline had to be adapted to the 2nd edition of GAMP 5.
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On 1 February 2024, the 5th edition of the renowned work “Leitfaden Klinische Prüfungen von Arzneimitteln und Medizinprodukten” was published. Edited by B. Sickmüller, Ch. Gleiter and C. Hinze, with contributions from many experts, present a complete revision and expansion of the content in this latest edition. The book serves as a standard work and reference in its field and covers a wide range of topics. It examines in detail the regulations and methods of clinical research, including the practical conduct of studies, with a particular focus on clinical pharmacological aspects. In addition, it addresses crucial issues relating to the safety of medicinal products and medical devices in clinical trials.
QFINITY is pleased to have contributed to this edition. Marcus Schwabedissen, Frank Henrichmann, Dr Jenny Gebhardt and Oliver Herrmann have written the chapter on “Validation of computerised systems”. This book is a comprehensive resource for drug and medical device research professionals.
further links: find out more and order here.
GAMP 5 Guide 2nd Edition
Maintaining the principles and framework of the first edition, published in 2008, the second edition provides updates for applications in the modern world. That includes the increasing importance of service providers, evolving approaches to software development, and the expanded use of software tools and automation. The authors, which include QFINITY’s Oliver Herrmann and Frank Henrichmann, also emphasize the importance of “critical thinking” by knowledgeable and experienced SMEs in defining the reliable approach to probability.
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ISPE GAMP Good Practice Guide: Enabling Innovation
The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management provides information to assist with:
– Introducing new and improved approaches to software engineering,
– the use of “as a service” (XaaS) offerings, including the use of supporting tools.
The Guide helps regulated organizations identify appropriate quality and validation approaches to make the best use of their resources.
In this GAMP® Good Practice Guide, the authors, which include Oliver Herrmann and Frank Henrichmann of QFINITY, discuss how critical thinking based on product and process knowledge, as well as quality risk management, helps to remove potential barriers when introducing new and innovative technologies.
further links: find out more and order here
ISPE GAMP Good Practice Guide (GPG):
Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice
This ISPE GAMP GPG on compliant systems in clinical research offers recommendations on how to meet the specific challenges of the 21st century in the validation and operation of computerized systems in the GCP field. The authors of the guide, including QFINITY∞’s Oliver Herrmann and Dr. Jenny Gebhardt, consider the increasing number, complexity, costs and patient centricity of clinical trials and focus on the need to implement a new model of a virtually integrated drug development process. This process must be supported by highly integrated computerized systems (from statistical programming platforms, data capture systems and Interactive Response Technologies (IRT) solutions to mobile electronic patient diaries and, in the near future, wearables) to collect, process and analyse clinical data. This guide addresses all of these issues, which represent a major challenge for ensuring adequate control by sponsors and other stakeholders such as CROs and technology providers.
Further links: Get more information and order now here!
PUBLICATION: PHARMA TECHNOLOGY JOURNAL – IT-TRENDS IN THE GXP-FIELD
Renowned authors from industry, consulting and suppliers provide insight into current trends and their practical application in the GxP area. QFINITY∞ is represented among the authors by Oliver Herrmann and Dr. Jenny Gebhardt (“Validation of computer-based GCP systems: Grundlagen, Ansätze, Herausforderungen und Trends”) and Dr. Stefan Schaaf (“Enterprise Management Systems as a Basis for GxP Compliance in the Life Science Industry”).
Further Links: Get more information and order now here! – ISBN: 978-3-87193-302-8
