IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments

In this case study, the focus is on the restoration of IT systems following a ransomware attack. It also considers ensuring compliance and data integrity through targeted IT quality management in a GxP-regulated environment. Problem statement The client is an…
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Global QMS concept for an international pharmaceutical company: design and implementation

This case study focuses on the design and implementation of a global QMS concept for an international pharmaceutical company. Problem Statement The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the…
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Development of a framework for the validation of computer-aided systems with AI components and introduction and validation of a high-performance AI and analytics platform

The project This project involved the introduction and validation of a high-performance AI and analytics platform and the development of a framework for the validation of computerized systems with AI components. The first step was a review of the CSV…
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Development of a validation framework for computerized systems incl. introduction and validation of a study management system

The project This project, at a university hospital, involved the introduction and validation of a study management system, including the development of a framework for the validation of computerized systems and the training of staff. A central component was the…
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Creation of a global quality management system

The project This project involved the creation of a global quality management system. QFINITY supported a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform quality management system for all areas…
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INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY

The project QFINITY supported a manufacturer of pharmaceutical products in the implementation and validation of a computerized particle monitoring system. This project included processes and services in the area of validation planning and execution. It also included the coordination and…
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INTRODUCTION OF A DOCUMENT MANAGEMENT SYSTEM (DMS)

The project This project is about the introduction of a document management system (DMS). QFINITY assumes the combined role of project manager and validation manager. With the support of QFINITY, a system selection was carried out that ensured the requirements…
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