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…

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…

ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026

QFINITY will be represented at the ISPE AI in Life Sciences Summit 2026 in Boston. The event will take place from 22–23 June. It brings together international experts from the fields of life sciences, validation, compliance, and digital innovation. Its…

ISPE EU Annual Conference | 20.-22. April 2026

Meet QFINITY on site at the ISPE EU Annual Conference 2026 in Copenhagen and learn how digital compliance, AI, and GxP requirements can be brought together in a safe, future-proof, and practical way. Event: ISPE EU Annual Conference 2026 Location:…

ACDM26 Conference with QFINITY | 15-17 March 2026

QFINITY will participate in the ACDM26 Conference in Berlin. The international conference is one of the leading events for professionals in Clinical Data Management and clinical research. In addition, it attracts those in regulatory affairs and digital innovation in the…

Volunteer Profile on Frank Henrichmann published in pharmaceutical Engineering

Our Senior Executive Consultant Frank Henrichmann is featured in the latest issue (January/February 2026) of Pharmaceutical Engineering. The magazine of the International Society for Pharmaceutical Engineering (ISPE) regularly publishes “volunteer profiles,” including the current one on Frank Henrichmann. The article…

Expert Article published in Pharmaceutical Engineering

Our expert article “How AI Will Transform Computerized System Validation” has been published in the latest issue of Pharmaceutical Engineering, the journal of the International Society for Pharmaceutical Engineering (ISPE). The article has also been published as a Feature Article…

Panel Discussion with QFINITY on the future of clinical computer systems

QFINITY took part in a key panel discussion at the Montrium’s Clinical QAI Day. The panel discussion focused on the future of clinical computer systems. The demands for quality and compliance in clinical environments continue to rise. At the same…

Successful Workshop on “Implementing an AI Solution in a Pharma 4.0 Context”

At this year’s ISPE Annual Meeting & Expo 2025, a successful GAMP & Pharma 4.0 Workshop took place, co-led by Frank Henrichmann together with Martin Heitmann, Brandi Stockton, and Paige Kane, PhD, CPIP, as well as several other experts. Under…

Frank Henrichmann Appointed Chair of the ISPE GAMP Global Steering Committee

QFINITY is pleased to announce that Frank Henrichmann, Senior Executive Consultant at QFINITY, has been appointed Chair of the ISPE GAMP Global Steering Committee. In this role, he succeeds Charlie Wakeham, whose exceptional commitment and inspiring leadership have significantly shaped…