Agent
Event detected
Out-of-spec assay flagged from the batch system and opened as a record.
T+0 min
Where the days go
Days a record stays open
Today
With agents
Record drafting
9 days → 4 hours
Evidence gathering
6 days → same day
CAPA follow-up
14 days → continuous
Root-cause investigation
unchanged — human work
Root cause doesn't move. That's the work you want your specialists doing.
One deviation, end to end
Agent
Record drafted
Narrative written to your template with linked batch, equipment, and training data.
T+18 min
Human
Root cause
Investigator reviews the assembled package and determines cause.
T+1 day
Human
Disposition
QA decides product impact and approves the classification.
T+1 day
Agent
CAPA tracked
Owners and due dates followed up automatically until every action closes.
T+2–30 days
Agent
Effectiveness verified
Evidence gathered on schedule and the conclusion drafted for sign-off.
T+90 days
What the inspector sees
Agent actions are recorded exactly like human ones — actor, timestamp, prior value, reason. Nothing is a black box, and nothing sits outside the approval chain.
Audit trail · DEV-2481
Complete
08:14:02
Agent
08:32:47
Agent
08:32:48
System
11:06:19
J. Okafor
11:41:55
M. Reyes
11:41:56
Agent
Controls