Accurate (ALCOA)

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).

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Your response lacks assurance that your EM testing results are accurate and reliable.

   FDA · FDA Warning Letter · 2025-11-25

2. You failed to accurately document microbiology sampling and testing results for components used in your over-the-counter (OTC) drug products.

   FDA · FDA Warning Letter · 2026-06-02

3. Poor or deficient sterility test facilities or controls can result in inaccurate data used by customers in determining final drug product batch disposition.

   FDA · FDA Warning Letter · 2022-08-30

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.