Glossary
Accurate (ALCOA)
The property of a record being free from error and correctly reflecting the facts and the activity performed.
Details
'Accurate' in the ALCOA principles is a data integrity attribute about whether a record truthfully represents what actually happened; it is a different concept from accuracy in analytical procedure validation, which is the closeness of a measured value to the true value. PIC/S PI 041-1 §7.5 explains that the accuracy of records is secured not by one control but by several elements of the quality system — qualification, calibration and maintenance of equipment together with computerised system validation, data review procedures that confirm the procedure was followed, deviation management including root cause analysis, impact assessment and CAPA, and trained people who understand why the procedures and records matter. Inspections cite manual transcription errors, unvalidated spreadsheet formulas, unit and rounding errors, corrections and overwrites made without a reason, values that changed after transfer between systems, and the absence of the input and output accuracy checks required by 21 CFR 211.68(b).
