Qualification Execution Checklist

Equipment: Electronic Lab Notebook / Data Capture (if used for GMP)

Subcategory: NDDS – CSV / Data Integrity for NDDS

Area: System

DQ/IQ/OQ/PQ Flags: Critical/Yes/Yes/Yes

CSV Required: Yes

Pre-Start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

GDP compliance ensured
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained