Audit Ledger
Immutable record of all system activities and compliance events.
Stability study initiated for RGT-500 shelf life extension
#690C8C30Post-market complaint #CLM-IVD-0087 logged
#554A517CFirmware v4.2 V&V protocol submitted for review
#668B803AElectronic Signature: Clinical data reviewed by Medical Director
#CD94EADDCAPA #IVD-2025-031 containment action: Lot 2026-R045 quarantined
#F6509D73Change Order CO-IVDR opened for Class C transition
#29EBA1EDIVDR reclassification CR approved by Regulatory Head
#5BB1534FDocument QM-001 updated to version 5.0
#3AAC218CStability study initiated for RGT-500 shelf life extension
#6BBC314APost-market complaint #CLM-IVD-0087 logged
#DA7286D1Firmware v4.2 V&V protocol submitted for review
#287517A8Electronic Signature: Clinical data reviewed by Medical Director
#D421931BCAPA #IVD-2025-031 containment action: Lot 2026-R045 quarantined
#6E971829Change Order CO-IVDR opened for Class C transition
#444C6B68IVDR reclassification CR approved by Regulatory Head
#0807BD73Document QM-001 updated to version 5.0
#364DD65AStability study initiated for RGT-500 shelf life extension
#66FFC82DPost-market complaint #CLM-IVD-0087 logged
#24B980FAFirmware v4.2 V&V protocol submitted for review
#57C5B8A4Electronic Signature: Clinical data reviewed by Medical Director
#1D5D69A1CAPA #IVD-2025-031 containment action: Lot 2026-R045 quarantined
#AA029C0AChange Order CO-IVDR opened for Class C transition
#9F1223D8IVDR reclassification CR approved by Regulatory Head
#AE7CC890Document QM-001 updated to version 5.0
#CC6CE649