Laboratory Data Review Checklist

Form ID: AA-CHK-QCL-DATA-REVIEW-EVT  |  Version: 1.0

Document Information

SOP: SOP-QCL-DATA
WIN: WIN-QCL-DATA-REVIEW
Checklist Type: Laboratory Data Integrity
Data Record ID: __________
Sample / Lot #: __________
System / Logbook: __________

Checklist Items

# Requirement Yes No N/A Objective Evidence / Comments
1 Laboratory data entries are complete, legible, and attributable to the individual performing the activity.
2 Data entries are contemporaneous and recorded at the time the activity was performed.
3 Original data or true copies are retained and protected from unauthorized modification.
4 Any data corrections are properly justified, documented, and approved in accordance with procedure.
5 Electronic data systems and audit trails support data integrity and are reviewed as required.

Approval

Performed By Date Signature
QA Review Date Signature

Electronic Record Statement:
This checklist is a controlled GMP record. Electronic entries and approvals are governed by the Quality Management System. Any use of controlled paper forms during validated system downtime shall be reconciled and reviewed by Quality Assurance.