Client:Aurora Pharma Ltd.·Validation Env·Tenant ID:aurora-prod-01
Validated System · 21 CFR Part 11 · GxP-aware
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Range

Value Set Administration

Controlled vocabularies and master data for this client deployment. Changes are audited and effective-dated.

Value sets

Deviation Categories

Code: DEV_CAT · Global scope · Last updated 2025-03-22

CodeNameDescriptionActiveEffectiveRetiredScopeUpdated
MIX_EXCMixing time excursionMixing duration outside validated rangeActive2024-01-01Global2025-03-22
TEMP_DEVTemperature deviationProcess temperature out of specActive2024-01-01Global2025-03-22
DOC_ERRDocumentation errorBMR/eBMR data entry issueActive2024-01-01Global2025-02-14
EQ_FAILEquipment malfunctionUnexpected equipment behaviorActive2024-01-01Global2025-01-09
ENV_DEVEnvironmental excursionHVAC / cleanroom excursionRetired2023-06-012025-01-15Site2025-01-15
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