Glossary
ALCOA+
The principle that data must be attributable, legible, contemporaneous, original, and accurate, and must also stay complete, consistent, enduring, and available.
Source · WHO Quality Assurance of Medicines Terminology Database, ALCOA+; WHO guideline on data integrity
Details
ALCOA+ is the practical standard that data be attributable, legible, contemporaneous, original and accurate, and in addition complete, consistent, enduring and available. Inspections do not stop at whether the principle is written into a procedure; they check whether it is actually implemented, looking at shared accounts, records made after the fact, discarded temporary records, missing data, change history, and whether records can still be retrieved years later. Look at raw data, metadata, audit trails, review records, privilege management, and retention and backup procedures across the whole data lifecycle.
Related sections
Related terms
Source
WHO Quality Assurance of Medicines Terminology Database, ALCOA+; WHO guideline on data integrityGRM Regulatory Glossary
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