What are the ALCOA+ principles?
The ALCOA+ principles are nine criteria regulators use to judge the integrity of regulated (GxP) data. ALCOA stands for attributable, legible, contemporaneous, original and accurate. The plus adds complete, consistent, enduring and available. The FDA, MHRA, WHO and PIC/S all build on ALCOA+, in manufacturing and in wholesale distribution alike.
Source: GxP Data Integrity Guidance and Definitions (MHRA)
T. LozerCompliance Strategy Specialist · entroit GmbH
· Updated
The nine principles
| Principle | What it means in the warehouse |
|---|---|
| Attributable | Every transaction shows who made it. A shared login breaks this principle. |
| Legible | Data stays readable for years, even without the software that created it. |
| Contemporaneous | Staff record each step as it happens, not from memory at the end of the day. |
| Original | The first capture counts, such as the scan or the measured value, not a copy of it. |
| Accurate | The value is correct. Plausibility checks catch impossible values. |
| Complete | Nothing is deleted silently. Corrections and repeats stay visible. |
| Consistent | Timestamps and sequence are right, and a batch carries the same data on every document. |
| Enduring | Data and audit trail outlast the retention period and any change of system. |
| Available | Data is ready within minutes during an inspection, not days. |
Some guidance documents speak of ALCOA++ and add traceable: every change must be traceable back to the original record.
Where ALCOA+ comes from
In the early 1990s, an inspector at the US Food and Drug Administration (FDA) summed up five qualities of good records in the acronym ALCOA to train colleagues. As records went digital, European regulators added four more. The UK regulator, the MHRA, set out ALCOA+ in its guidance on data integrity.
Why ALCOA+ matters in wholesale
No law cites ALCOA+ as a clause. But the principles sit inside the requirements for documentation and computerised systems, in Good Distribution Practice (GDP) just as in EU GMP Annex 11. During a GDP inspection, inspectors measure goods receipt, batch records, temperature data and the audit trail against them.
How an inventory management system meets ALCOA+
You can meet each principle through diligence, or through a system that enforces it. An inventory management system for pharmaceutical wholesale or for medical devices stamps every transaction with the user and a timestamp automatically. It keeps versions of values instead of overwriting them. Mandatory fields prevent gaps, and a single data model keeps every document consistent.