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Oliver Herrmann Led the GAMP Track at the ISPE Europe Annual Conference 2026
At the ISPE Europe Annual Conference 2026 in Copenhagen (April 20-22), Oliver Herrmann, Founder and CEO of QFINITY, served as Track Lead for the GAMP track „Digital Compliance by Design: GAMP, AI, data integrity and digital validation in a digitalized world“.
The life sciences industry is going through a profound digital transformation. Cloud platforms, AI-enabled tools and automation are changing how systems are built, validated and operated. These technologies open up opportunities; they also bring new risks and regulatory expectations.
At the heart of the track was the question of how „compliance by design“ works in practice: building conformity into processes, systems and technologies from the start, so that innovation can proceed without putting GxP compliance at risk. A particular focus was data integrity as the foundation for AI: without trustworthy, well-governed data, AI systems cannot perform reliably, least of all in regulated environments.
The track featured contributions on:
The sessions centered on case studies, lessons learned and forward-looking perspectives on emerging technologies and upcoming regulatory developments.
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 statement
The client is an international company in pharmaceutical active ingredient research. Its services include researching and developing new active ingredients and building software platforms for specialized methods in this environment. The company became the target of a ransomware attack that encrypted large parts of its infrastructure, systems, and data, making them inaccessible. Because some of these data and systems were GxP-relevant, the restoration of IT services and functions had to be closely overseen – and fully documented from an IT quality management perspective.
To achieve this objective, the client required:
Project execution
At the start of the project, QFINITY recorded the recovery activities defined by the project team and evaluated their regulatory relevance. The results of the forensic analysis of the ransomware attack fed into this work, serving to review the effectiveness of existing quality management processes and optimize them where necessary. Based on this analysis, QFINITY developed a quality plan covering the following activities and areas:
Implementing this plan and the associated activities required intensive coordination with all departments to enable a fast, secure release of IT services and systems in full regulatory compliance.
Results and benefits
The project was completed successfully on schedule and within the planned budget because analysis, documentation, and release activities were appropriately scaled and efficiently coordinated. The restored IT systems and associated data fully meet all internal and regulatory requirements. Throughout the recovery, internal quality assurance continuously monitored the documentation in close coordination with the IT quality function, ensuring complete regulatory compliance and adherence to the highest internal quality standards. The resulting IT infrastructure meets the most stringent requirements for security, data integrity, and operational reliability.
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.
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 international company in pharmaceutical active ingredient research. Its services range from researching and developing new pharmaceutical compounds to building software platforms for specialized methods in this domain.
After years of significant growth through acquisitions, the company needed to consolidate its various quality management approaches into a harmonized global Quality Management System (QMS).
To achieve this objective, the client required:
Project Execution
In the initial phase, QFINITY analyzed the organization’s existing quality management systems and evaluated them against regulatory requirements and industry standards.
QFINITY then developed a new QMS concept covering the following areas:
As part of the implementation, QFINITY developed all necessary policies, directives, SOPs, work instructions, and document templates. It also created training materials for all relevant areas and planned and ran training sessions for the respective employee groups and departments.
Results and Benefits
The project was completed successfully on time and within the planned budget. Appropriately scaling the analysis, development, and rollout activities – and coordinating them efficiently – made this possible. Potential bottlenecks were identified early and avoided, keeping the overall project timeline on track.
The implemented global QMS significantly improved both efficiency and compliance. Globally harmonized processes and approaches ensured consistent compliance with regulatory requirements across the entire organization. Process efficiency increased substantially, and the company established a unified global understanding of quality.
The company’s internal quality assurance function reviewed the QMS approach and related documentation, and any inconsistencies identified were resolved promptly before rollout.
For more information about QFINITY’s case studies, check out our Project News.