Enabling GxP-Compliant Cloud Services through Global QMS Enhancement

A CDMO wanted to use cloud services – including hosting GxP-relevant systems. QFINITY evolved the global quality management system so that Infrastructure as a Service, Infrastructure as Code, and cloud operation and monitoring are covered in a fully GxP-compliant way…
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IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments

After a ransomware attack, a drug-discovery company had to recover GxP-relevant systems and data – fully documented. QFINITY guided the recovery from an IT quality management perspective: from forensically grounded quality planning through integrity-assured data migration to validated release. Problem…
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Global QMS concept for an international pharmaceutical company: design and implementation

Grown through acquisitions, an international pharmaceutical company needed a harmonized global QMS. QFINITY designed and implemented it along GAMP 5 and ITIL – across infrastructure, software development, and computerized system validation – including a training concept and a worldwide rollout.…
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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

A mid-sized pharmaceutical company introduced and validated a high-performance AI and analytics platform. QFINITY extended the validation strategy to the specifics of computerized systems with AI components, revised CSV processes and SOPs, and supported training, supplier qualification, and validation documentation.…
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Development of a validation framework for computerized systems incl. introduction and validation of a study management system

A university hospital introduced a clinical study management system. QFINITY built a tailored validation framework, ran the vendor audit as part of supplier qualification, and continuously advised the study center on national and international regulatory requirements. The project This project…
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Creation of a global quality management system

A globally positioned service provider, grown through acquisitions, needed a single QMS for IT and computerized systems. QFINITY harmonized the processes in line with GAMP 5 and ITIL – from concept through the design and documentation of individual processes to…
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INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY

A pharmaceutical manufacturer implemented a computerized particle monitoring system within a tight production window. QFINITY analyzed the manufacturer’s and SAT documentation and derived a highly efficient documentation approach that enabled implementation and release on time and in regulatory compliance. The…
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INTRODUCTION OF A DOCUMENT MANAGEMENT SYSTEM (DMS)

A company replaced its paper-based and outdated document processes with a central document management system. QFINITY took on both project and validation lead – from requirements-based system selection through a validated prototype to the phased replacement of the legacy system.…
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