Publications that shape the industry.
QFINITY consultants are key contributors to the standard reference works of the GxP world. These include ISPE GAMP guides, technical books and journal articles. This overview shows the publications.
Recent work on AI, GAMP 5 and disaster recovery.
Here you will find publications QFINITY consultants have contributed to, as authors or as interviewees, from the September 2026 interview back to the 2014 concept papers.
Building Trust In AI For Computerized System Validation
Frank Henrichmann (QFINITY) in conversation with Life Science Connect: where AI can be relied on in computerized system validation, where human judgment remains indispensable and which controls make the difference.
- Reliably automated: completeness, traceability and consistency
- Stays with people: judging whether evidence is adequate and assessing deviations
- Automation bias and cognitive ease call for independent technical controls that hold even when human review slips
Human-in-the-Loop as an Illusion of Control?
In AI-supported GxP processes, human review often offers less protection than the audit narrative promises. Frank Henrichmann and Oliver Herrmann (QFINITY) describe a multi-layered control system that establishes detectability.
- Automation bias, the plausibility trap and review fatigue can reduce Human-in-the-Loop (HITL) to a gesture
- CSV use cases: test review and traceability agents, where a green light replaces analysis
- HITL as one layer in a control system of people, process and technology
How AI Will Transform Computerized System Validation
Oliver Herrmann and Frank Henrichmann (QFINITY) show how teams can use AI to make computerized system validation smarter without giving up its role as evidence.
- AI-supported workflows: traceability, test evidence and an audit-ready evidence trail
- The value depends on clear processes, precise requirements and a structured risk assessment
ISPE GAMP 5: Second Edition - Neues Denken für eine effiziente Validierung (New Thinking for Efficient Validation)
German-language article by Oliver Herrmann and Frank Henrichmann (QFINITY) on the GAMP 5 Second Edition: a reform, not a revolution.
- Critical Thinking (new appendix) before formal compliance
- CSA as a scalable approach to testing and evidence
- Efficiency comes when effort follows risk and patient proximity
Quality Considerations in Disaster Recovery
QFINITY article (Henrichmann, Herrmann, Schwabedissen; with M. Stroebe/Janssen) on the role of quality management in disaster recovery for regulated environments.
Guides, books and articles since 2014.
The Importance of GAMP in the Pharmaceutical IndustryFrank Henrichmann (QFINITY) co-authored this iSpeak post (ISPE's blog format) together with Christopher Reid, Heather Watson and Sion Wyn. It sets out how the GAMP 5 Guide informs the validation of computerized systems and the assessment of their fitness for the intended use (fit for purpose).
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Read the post at ISPE iSpeak↗
Computerized GCP Systems and Data, 2nd EditionThe second edition of the GAMP guide covers the validation and compliance of computerized clinical systems. It was developed by 48 industry experts, among them members of the QFINITY team.
→ Read the publication
Leitfaden Klinische Prüfungen (Guide to Clinical Trials) - Validation of Computer SystemsIn the standard reference on clinical research (eds. Sickmüller, Gleiter, Hinze, 5th edition), QFINITY (Schwabedissen, Henrichmann, Gebhardt, Herrmann) wrote the chapter "Validation of Computer Systems": validation comes from process knowledge, not from IT.
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View the book at ECV↗
GAMP 5 Guide, 2nd EditionThe second edition of the GAMP 5 Guide includes updates on software development, service providers and automation. Oliver Herrmann and Frank Henrichmann (QFINITY) were on the core team of the revision.
→ Read the publication
Enabling Innovation - Critical Thinking, Agile, IT Service ManagementThe guide covers Critical Thinking, Agile and IT Service Management. It helps regulated organizations determine appropriate quality and validation approaches. QFINITY authors contributed to it.
→ Read the publication
GAMP RDI Good Practice Guide: Data Integrity - Key ConceptsQFINITY contributed to this ISPE GAMP RDI Good Practice Guide. The guide explains the key concepts of data integrity: the ALCOA principles, data governance, the data lifecycle, records by design and a depth of control that follows data criticality. It belongs to the GAMP RDI series of guides (Records and Data Integrity) and is aligned with GAMP 5.
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View the guide at ISPE↗
Enterprise Management Systems as a Basis for GxP ComplianceDr. Stefan Schaaf (Q-FINITY Qualitätsmanagement) shows why GxP compliance depends on how processes actually work in practice. He also explains how an integrated enterprise management system connects quality, risk and governance into one control loop.
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Read the article at Pharm. Ind. (ECV)↗
Validation and Compliance of Computerized GCP Systems and DataThe guide offers practical guidance on validating and operating computerized GCP systems. Its authors include Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY).
→ Read the publication
Processes as the Skeleton of Quality CultureDr. Stefan Schaaf (Q-FINITY Qualitätsmanagement) sets out why quality culture needs a skeleton: processes that are understood and documented. The turtle diagram, SIPOC and RACI make them visible and manageable.
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Read the article on LinkedIn↗
Draft Addendum to ICH E6 Meets ALCOA: Moving Toward a Practical Definition of Data IntegrityThe article by Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY) appeared in RQA's international New Year issue. It develops a practical definition of data integrity in the GCP environment from the ALCOA principles and a process- and risk-based view of the entire data lifecycle.
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View RQA Quasar↗
Validation of Computerized GCP SystemsThe two-part series by Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY) covers the fundamentals and the regulatory framework in Part 1; Part 2 covers data handling, data integrity and trends. It follows a risk-based approach and treats data as the product of clinical research.
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Read the series at Pharm. Ind. (ECV)↗
IT Trends in the GxP EnvironmentThe book covers the IT trends that shaped the GxP field at the time. QFINITY authors contributed sections on the validation of computerized GCP systems and on enterprise management systems.
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Validation and Data Integrity in eClinical PlatformsThe second concept paper from the ISPE GAMP R&D and Clinical Systems SIG was written against the backdrop of the EU Clinical Trials Regulation and the shift to electronic processes.
Computerized Systems in the GCP EnvironmentThis was the first concept paper from the ISPE GAMP R&D and Clinical Systems SIG, which QFINITY led at the time. It reconciles the GAMP 5 principles with GCP requirements, using an EDC system as the worked example.
Who publishes at QFINITY.
Members of the QFINITY team contributed to the publications on this page. They cover the areas we work in: validation, data integrity, GCP systems, quality management and AI in the GxP environment.
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