In a regulated plant, the product can be perfect and the audit can still fail, because the records are not trustworthy. That is what data integrity is about.
For pharmaceutical, biotech, and medical-device manufacturers, the data behind every batch, every piece of equipment, and every quality check has to be as reliable as the product itself.
This guide explains GMP data integrity in plain terms, the ALCOA principles that define it, and how the way you capture operational data either protects or undermines your compliance.
See our guide to the CMMS side of GMP evidence.
Data integrity, under Good Manufacturing Practice, means the data your operation generates is complete, consistent, and trustworthy across its entire life, from the moment it is created to the moment it is archived.
Regulators including the FDA and EMA treat data integrity as central to GMP, because if the data cannot be trusted, neither can the product decisions made from it. Data-integrity findings are among the most common and most serious issues in regulatory inspections.
Regulators describe trustworthy data with the ALCOA framework, later extended to ALCOA+.
ALCOA+ adds that data should also be complete, consistent, enduring, and available. Together these are the test an auditor applies to your records.
Most data-integrity problems are not fraud. They are the predictable result of manual processes. A value written on paper at the end of a shift is not contemporaneous. A shared login breaks attributable. A number transcribed from a machine to a logbook to a spreadsheet loses original and invites error. Every manual handoff is a place where integrity weakens, which is exactly what auditors probe.
The most reliable way to satisfy ALCOA is to remove the manual steps. When operational data is captured automatically from the equipment, in real time, with each entry tied to a user and a timestamp, you get attributable, contemporaneous, original data by design rather than by discipline.
This applies directly to the production and maintenance records a regulated plant lives on. Equipment monitored in real time produces a timestamped, attributable record of how it ran. Maintenance and calibration tracked in a CMMS produce an audit trail of who did what and when.
Quality data tied to the line, in the spirit of statistical process control , is captured as it happens. The same automation that improves OEE also hardens data integrity, because both depend on accurate, real-time, tamper-resistant data.
For electronic records and signatures, the FDA's 21 CFR Part 11 sets the specific expectations: secure audit trails, access controls, and validated systems. Data integrity is the broader principle; Part 11 is one of the rulebooks that enforces it for electronic systems. Software used for production and maintenance records in a regulated plant should support these controls so your electronic data stands up to inspection.
Attributable, Legible, Contemporaneous, Original, and Accurate. ALCOA+ adds complete, consistent, enduring, and available. Together they define what regulators consider trustworthy data.
Because product-quality and patient-safety decisions are made from the data. If the records cannot be trusted, the product cannot be trusted, which is why data-integrity findings are treated as serious in inspections.
It removes the manual steps where integrity breaks. Data captured automatically from equipment, with user attribution and timestamps, is contemporaneous, attributable, and original by design, which is what ALCOA requires.
No. Data integrity is the overall principle that data must be trustworthy. 21 CFR Part 11 is a specific FDA regulation for electronic records and signatures that enforces parts of it.
Fabrico captures production, downtime, quality, and maintenance data automatically and in real time, with the timestamps, user attribution, and history that data integrity demands, so the same records that drive your OEE also stand up in an audit. Book a short demo to see how it would fit a regulated plant, or start with the OEE basics.
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