Complete and sign batch records

Completing a batch record turns an in-progress run into a permanent, signed document. This is the final quality control gate before a batch is released.

Complete the run

1. Confirm every step in the issued record has been executed.
2. Check that all required measurements, in-process checks, and lot entries are filled in.
3. Resolve any failed checks or open deviations before moving on.
4. Mark the record complete.

A record with missing data or unresolved failed checks should not be completed. Close the gaps first so the document is accurate and defensible.

Review and sign

Compliant production typically needs two roles:

Role	Responsibility
Operator	Performs the steps and records the data
Reviewer / QA	Independently checks the record and signs to release

1. The reviewer verifies the completed record against the procedure.
2. Each required sign-off is captured, identifying who performed the action and when.
3. The reviewer applies the final signature to release the batch.

Separation of duties matters: the person who recorded a step generally should not be the one who verifies it. Use distinct sign-offs to preserve the audit trail.

Lock the record

Once signed, the record is closed and becomes read-only. Corrections after closing are made through a documented amendment, never by editing the original.

Next steps

A closed record feeds lot genealogy and traceability so you can trace every batch end to end.