The batch record states the instrument was calibrated. The maintenance system shows calibration overdue on the date of use.
Step-by-step process flow:
Today
The reviewer trusts the record, because checking the maintenance system for every instrument is not practical.
The agent
Reads instrument IDs from the record and calibration history from the maintenance system for the dates of use.
Next
A follow-up to maintenance and QA, tracked until assessment.
Release, certify or disposition a batch
Close a deviation, investigation or CAPA
File anything with an authority
Write to your systems outside the transitions you approve
Send a message without a named person's approval
Contact a regulatory authority or a customer
Promote itself to a higher autonomy level
Make you compliant. Compliance decisions and accountability stay with you.
REVIEW AND REGULATION
The reviewer sees
The instrument, the date of use, the due date and the record statement, side by side.
Regulation
21 CFR 211.68 and 211.160(b)(4), equipment and instrument calibration.
What does the agent do for an instrument used past its calibration due date?
The agent reads instrument IDs from the record and calibration history from the maintenance system for the dates of use.
What does the reviewer see?
The instrument, the date of use, the due date and the record statement, side by side.
What happens after the reviewer confirms?
A follow-up to maintenance and QA, tracked until assessment.
Does the agent make the decision?
No. The agent prepares the finding and a named person decides. The agent never releases, certifies or dispositions a batch, never closes a deviation, investigation or CAPA, and never files anything with an authority.
Which regulations apply?
21 CFR 211.68 and 211.160(b)(4), equipment and instrument calibration.
Send an export for one batch or lot and see the workspace run on your own data.
