Electronic Batch Record Review-by-Exception Checklist

EBR Configuration and Validation

Establish the electronic record foundation.

• Is the electronic master batch record configured to reflect the approved master production and control record? *
• Are automated in-process checks, limits, and interlocks validated in the MES? *
• Are enforced sequencing and mandatory data entries configured to prevent skipped steps? *

Review by Exception Design

• Is the review-by-exception model defined so that automatically captured, in-limit data need not be re-reviewed manually? *
• Are exceptions, deviations, and out-of-limit events automatically flagged for mandatory review? *
• Is the risk-based rationale for the scope of exception review documented and approved? *

Exception Handling and Data Integrity

• Are all flagged exceptions resolved and dispositioned before batch release? *
• Are audit trails for the batch record reviewed for critical data as part of disposition? *
• Are corrections made with attributable, time-stamped, reason-documented entries? *

Release and Governance

• Does the quality unit perform the final review and approval of the electronic batch record before release? *
• Are role-based permissions and electronic signatures enforced for review and approval steps? *
• Is the EBR system maintained under change control and periodic review? *