Welcome to the seventh instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals.
In this edition, we examine why data integrity is the bedrock of GMP compliance – and how failure to uphold it can lead to regulatory action, reputational damage, or patient harm. With authorities like the FDA, EMA, and MHRA tightening expectations around electronic and paper-based records, robust data governance is no longer optional.
Discover how Rephine’s structured approach to data integrity audits, PQS integration, and cultural transformation helps life sciences companies go beyond checkbox compliance to build systems that regulators—and patients—can trust.
In today’s regulatory environment, data integrity is not just a technical requirement—it’s a cornerstone of trust.
Without transparent, reliable data, even the most sophisticated GMP systems risk collapse.
Auditable, accurate records are now the gold standard, and regulators are raising the bar.
Why Data Integrity Is Critical to GMP Compliance
In pharmaceutical manufacturing, data integrity is the foundation of trust—both for regulatory compliance and patient safety. Any gap in the integrity of production, laboratory, or quality control data can lead to regulatory warning letters, import bans, or, worse, harm to end users.
What Global Regulators Expect on Data Integrity
The FDA, EMA, MHRA, and WHO have all issued explicit guidance stating that data integrity violations are unacceptable. In recent years, it has become one of the most cited root causes of GMP non-compliance worldwide.
Core Requirements: ALCOA and ALCOA+ Principles
Authorities require that all GMP-related data—electronic or paper-based—be: – Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA and ALCOA+ principles) – Stored securely with access control, audit trails, and change management – Reviewed regularly with procedures that detect data manipulation or omission – Fully traceable and backed by validated systems
Common Causes of Data Integrity Failures
Data integrity breaches often stem from weak system design, poor documentation practices, or a culture where quality is deprioritized under operational pressure.
Rephine’s Approach to Data Integrity Auditing
Data integrity breaches often stem from weak system design, poor documentation practices, or a culture where quality is deprioritized under operational pressure.
✅ Third-Party Data Integrity Audits: We perform in-depth audits across manufacturing and QC operations, identifying weaknesses in system controls, documentation, user access, and electronic records.
✅ Gap Assessments and Remediation Plans: Rephine helps companies evaluate their compliance against EMA, FDA and WHO expectations, and develop realistic, prioritized action plans.
✅ PQS Integration: We assess how data governance fits within your Pharmaceutical Quality System, including deviation handling, batch release, and CAPA effectiveness.
✅ Audit Report Library: For clients qualifying CMOs or CROs, our high-quality audit reports provide visibility into data integrity risks in your supply chain—without redundant audits.
✅ Training and Culture Development: Rephine supports the creation of a compliance culture by training staff on the “why” of data integrity, not just the “how”.
From Risk to Resilience: Building a Culture of Data Integrity
Rephine’s focus on independent GMP audits, conflict-free assessments, and expert consulting ensures that your data systems can withstand regulatory scrutiny and operational demands. With the right controls, processes, and mindset, your organization can move from vulnerability to compliance confidence.
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.