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Life-Sciences eQMS 15 items

Data Integrity (ALCOA+) Assessment Checklist

Evaluates GxP data against the ALCOA+ principles to confirm records are attributable, legible, contemporaneous, original, and accurate. Use for self-inspection, supplier audits, and data governance review.

ALCOA+21 CFR 21121 CFR Part 11MHRA GxP Data Integrity Guidance

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Data Governance

  • Is there a documented data governance program defining data integrity roles, responsibilities, and controls? *
  • Has a data criticality and risk assessment been performed for key GxP systems and processes? *
  • Are both paper and electronic (hybrid) records controlled to prevent gaps in the true record? *

Attributable

  • Can every entry be traced to a unique, identified individual who made it? *
  • Are shared/generic login accounts prohibited for GxP-critical systems? *

Legible and Enduring

  • Are records permanent, legible, and made in indelible media (no pencil, correction fluid, or overwriting)? *
  • Are corrections made by single-line strike-through with initials, date, and reason? *

Contemporaneous

  • Are records made at the time the activity is performed? *
  • Are system clocks synchronized and protected from user modification? *

Original and Accurate

  • Is the original record or a certified true copy retained? *
  • Are results accurate, free from errors, and verified against the source? *
  • Is there evidence that no unauthorized deletion or reprocessing of data occurred? *

Complete, Consistent, Available

  • Is all data including repeat/reanalysis and metadata retained (nothing selectively excluded)? *
  • Are data and their audit trails available for review throughout the retention period? *
  • Record the date of the last data integrity audit trail review.

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