The original five attributes are attributable, legible, contemporaneous, original and accurate. Later regulatory guidance added complete, consistent, enduring and available — the “plus”. The FDA’s data integrity guidance, the MHRA GxP data integrity guidance, PIC/S PI 041 and WHO’s data integrity guideline all describe data integrity in these terms, so ALCOA+ is effectively the common standard across markets.
The nine attributes
- Attributable — it is clear who performed an action or recorded data, and when.
- Legible — data is readable and permanent, throughout the retention period.
- Contemporaneous — data is recorded at the time the work is done.
- Original — the first capture of the data, or a verified true copy, is preserved.
- Accurate — data is correct and truthful, with any changes documented and justified.
- Complete — all data is present, including repeats, reprocessing and metadata, with nothing deleted or hidden.
- Consistent — data follows a consistent sequence, with dates and times in order and processes applied the same way.
- Enduring — data is recorded on durable, controlled media and lasts for the retention period.
- Available — data can be accessed for review, audit and inspection whenever needed, for its whole lifetime.
ALCOA+ is a set of principles, not a certification. No system is “ALCOA+ certified”. What matters is whether your records — paper, electronic and hybrid — show these attributes when an inspector looks at them, and whether your controls make failures unlikely and detectable.