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PHARMA-COMPLIANCE5 MIN READ

Data Integrity Rescue Cards

Recall practical responses to common data-integrity failure modes using ALCOA+.

ALCOA+ What does ALCOA+ protect in one line? Think record truth over record neatness. But I did the check on time. I only wrote it later. Delayed GMP record entry. Your line Then we preserve both truths: when the check happened and when the record was actually entered, with the reason for late entry. Do not backfill the record to make it look contemporaneous. This avoids accusing the person while protecting contemporaneous and accurate documentation. Correction or backdating? A correction explains the truth. Backdating disguises the truth. What is the first move when a critical audit-trail anomaly is found? Preserve…

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