ALCOA+ is a shorthand for data integrity attributes used to help ensure that records are trustworthy throughout their lifecycle. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The “plus” commonly refers to data being Complete, Consistent, Enduring, and Available.
What do the ALCOA principles mean?
- Attribuibile: it is clear who created or changed the data and when.
- Leggibile: the record can be read and understood throughout its retention period.
- Contemporaneo: the information is recorded when the activity happens.
- Originale: the record is the first capture of the information or a verified true copy.
- Preciso: the record reflects what actually happened and is free from errors or unexplained changes.
The “plus” extends these attributes across the record’s lifecycle:
- Completo: all required data and relevant context are retained, including corrections and repeat results where applicable.
- Consistent: dates, times, sequences, and related records are coherent.
- Enduring: records remain protected and readable for the required retention period.
- Available: authorized people can retrieve records when needed for review or inspection.
How is ALCOA+ used?
Organizations use ALCOA+ to frame good documentation practices and assess data-integrity risks. The principles apply to paper, electronic, and hybrid records, including manufacturing data, laboratory results, quality events, and audit trails. Controls may include attributable user accounts, contemporaneous data capture, secure audit trails, backup and recovery, controlled corrections, and tested record retrieval.
ALCOA+ is a practical set of data-integrity attributes, not a standalone regulation or a substitute for applicable requirements. FDA guidance describes CGMP data integrity in terms of complete, consistent, and accurate data and uses the ALCOA attributes. MHRA guidance discusses ALCOA and explains that the “plus” attributes express the same lifecycle expectations.
ALCOA+ in digital manufacturing
A manufacturing system can support data integrity by capturing who performed a step, when it was completed, the values entered, and any subsequent changes. That support depends on suitable configuration, procedures, training, and review. A system feature alone does not establish that every record is complete or accurate.
See the FDA’s Data Integrity and Compliance With Drug CGMP guidance and the MHRA’s GxP Data Integrity guidance.