eQMS Ilmu Hayati 15 butir
Data Integrity (ALCOA+) Assessment Checklist
Daftar periksa ini dalam bahasa Inggris.
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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