Publications that shape the industry.
QFINITY people are key contributors to the standard references of the GxP world - from ISPE GAMP guides to specialist books and journal articles. An overview of the publications that shape how the industry works day to day.
Knowledge that becomes a standard reference.
Below you'll find an overview of the publications and papers QFINITY people have played a significant part in. Several are regarded as standard references in the industry and still shape its day-to-day work.
How AI Will Transform Computerized System Validation
Article by Oliver Herrmann and Frank Henrichmann (QFINITY): how AI makes computerized system validation smarter instead of replacing it.
- AI-supported workflows: traceability, test evidence and audit-ready records
- Value tied to the inputs: clear processes, precise requirements, structured risk assessment
- Authors: Oliver Herrmann + Frank Henrichmann (QFINITY)
ISPE GAMP 5 Second Edition - 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 testing and documentation approach
- Efficiency from risk, not from routine - patient-centered
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.
The full track record.
The Importance of GAMP in the Pharmaceutical IndustryFrank Henrichmann (QFINITY) co-authored this iSpeak post (an ISPE blog format) together with Christopher Reid, Heather Watson and Sion Wyn. It sets out why GAMP 5 guidance provides the framework for validating and running computerized systems fit for purpose. Henrichmann's role as Chair of the GAMP Global Steering Committee underscores the point.
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Read the post at ISPE iSpeak↗
Computerized GCP Systems and Data, 2nd EditionThe second edition of the GAMP guide for validating and ensuring the compliance of computerized clinical systems - the most comprehensive guide of its kind, developed by 48 industry experts, including QFINITY.
→ Read the publication
Leitfaden Klinische Prüfungen - 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 - updated for modern software development, service providers and automation. On the core team of the revision: Oliver Herrmann and Frank Henrichmann (QFINITY).
→ Read the publication
Enabling Innovation - Critical Thinking, Agile, IT Service ManagementA guide to critical thinking, Agile and IT Service Management - helping regulated organizations identify the right quality and validation approaches. Co-authored by QFINITY.
→ Read the publication
GAMP RDI Good Practice Guide: Data Integrity - Key ConceptsA Good Practice Guide from ISPE GAMP RDI, co-created by QFINITY - the authority anchor of our data integrity pillar. It puts critical thinking and cultural excellence to work for data integrity in everyday practice and anchors ALCOA++ across the data lifecycle. Positioned under the GAMP Guide Records and Data Integrity and 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 the process, not the manual - and how an integrated enterprise management system connects quality, risk and governance into a working control loop.
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Read the article at Pharm. Ind. (ECV)↗
Validation and Compliance of Computerized GCP Systems and DataPractical guidance on validating and operating computerized GCP systems in the 21st century. Authors include Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY).
→ Read the publication
Processes as the Skeleton of Quality CultureDr. Stefan Schaaf (Q-FINITY Qualitätsmanagement) shows why quality culture needs ground to grow on: processes that are understood and documented. The turtle diagram, SIPOC and RACI make them visible and manageable - without that skeleton, improvement stays guesswork.
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Read the article on LinkedIn↗
Draft Addendum to ICH E6 Meets ALCOA: Moving Toward a Practical Definition of Data IntegrityAn article by Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY) in RQA's international New Year issue: a practical definition of data integrity in the GCP environment - through the ALCOA principles and a process- and risk-based view of the entire data lifecycle. Evidence that QFINITY's data integrity track record reaches back to 2016.
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View RQA Quasar↗
Validation of Computerized GCP SystemsA two-part series by Oliver Herrmann and Dr. Jenny Gebhardt (QFINITY): fundamentals and the regulatory framework (Part 1), handling data, data integrity and trends (Part 2) - risk-based, with data as the product of clinical research.
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Read the series at Pharm. Ind. (ECV)↗
IT Trends in the GxP EnvironmentCurrent IT trends in the GxP field - QFINITY on the author team, contributing chapters on the validation of computerized GCP systems and on enterprise management systems.
→ Read the publication
Validation and Data Integrity in eClinical PlatformsThe second concept paper from the ISPE GAMP R&D and Clinical Systems SIG - written against the backdrop of the EU Clinical Trials Regulation and the shift to electronic processes.
Computerized Systems in the GCP EnvironmentThe first concept paper from the QFINITY-led ISPE GAMP R&D and Clinical Systems SIG - reconciling the GAMP 5 principles with GCP requirements, using an EDC system as the worked example.
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