Raising the Bar in GxP Compliance – Part 19: Data Integrity & ALCOA+: Building Trust in Every Data Point
Welcome to the nineteenth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals. In this edition, we focus on data integrity—the cornerstone of credible, compliant GxP operations. As global regulators like the FDA, EMA, MHRA, and PIC/S continue to emphasise ALCOA and ALCOA+ principles, the demand for accurate, attributable, and enduring data has never been greater. From lab records to computerised systems, organisations must ensure that data is not only complete and consistent but also protected by a robust quality culture. Discover how Rephine supports clients in embedding these principles into daily practice to drive sustainable compliance and inspection confidence.
In today’s data-driven GxP environment, integrity isn’t optional—it’s fundamental.
Regulators expect data to be complete, consistent, and readily accessible, making ALCOA+ principles essential to every compliant operation. Weak data governance is now a red flag for deeper systemic issues.
Why Data Integrity Matters in GxP Environments
In the highly regulated pharmaceutical and biotech industries, data integrity is not simply a documentation requirement — it is the foundation upon which regulatory compliance, product quality, and ultimately patient safety are built. Any compromise in data integrity can undermine the entire GxP compliance system, leading to regulatory findings, product recalls, or even market suspensions.
What Is ALCOA? The Foundation of Trustworthy Data
One of the most universally recognised frameworks for ensuring data integrity is the ALCOA principle, expanded in many cases into ALCOA+. Both concepts are central references in multiple regulatory guidelines, including FDA, EMA, MHRA, and PIC/S.
Breaking Down ALCOA: The Five Core Principles
The acronym ALCOA summarises five essential attributes that all GxP data must meet:
- Attributable: It must be clear who performed an action and when.
- Legible: The data must be readable and permanent.
- Contemporaneous: Data must be recorded at the time the activity is performed.
- Original: The first recorded data or a certified true copy must be retained.
- Accurate: Data must reflect the real observation or measurement, without error or manipulation.
The Evolution to ALCOA+: Reinforcing Data Integrity
Over time, regulators have extended ALCOA into ALCOA+, adding further dimensions to reinforce integrity:
- Complete: All data, including repeated measures, aborted runs, deviations, must be included.
- Consistent: Data must follow a consistent chronology and sequence.
- Enduring: Data must be retained securely over its entire lifecycle.
- Available: Data must be readily accessible for review and audit at any time.
Why Data Integrity Failures Are a Red Flag for Regulators
Major inspection agencies consistently highlight data integrity breaches as one of the most serious non-conformities. Typical failure modes include:
Common Data Integrity Breaches in Pharma
- Backdating records
- Incomplete laboratory raw data
- Unauthorised changes to electronic records
- Lack of audit trails
- Shared passwords and uncontrolled system access
Such violations signal not only procedural gaps but often point to weak quality culture and insufficient management oversight.
How Rephine Supports End-to-End Data Integrity
Our Approach: From Gap Assessments to Quality Culture
At Rephine, we integrate data integrity assessments across both third-party audits and GxP consulting services, ensuring our clients:
✅ Identify and remediate weak points in their data governance systems.
✅ Validate computerised systems to comply with 21 CFR Part 11 and Annex 11.
✅ Implement robust audit trail reviews, periodic reviews, and access control mechanisms.
✅ Strengthen quality culture to promote real-time, accurate, and reliable data recording.
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.