Intelligence and automation
Q Agent and alerts
Hand Q Agent a goal and it works it across the QMS (logs complaints, opens investigations, drafts root cause analyses, runs triage and signal detection, flags, emails and schedules), waiting for your approval. Alerts tell the right people when a record needs them.
In the portal: /app/q-agent
Give Q Agent a task
- Person
1. Write the goal
What should Q Agent do?
- Person
2. Choose autonomy
Ask before every action, or create drafts
- AI drafts
3. Plan and work
Reads records, proposes actions
- Person
4. Approve or dismiss
Each action, with an optional note
- System
5. Actions run in your name
- AI drafts
6. Final report
Outcome, what it did, waiting on people
- Records Q Agent creates start in review and still need a qualified person to review and sign.
- Step 1: Open Q Agent, write the goal (10 to 4,000 characters) and choose what it may do without asking: Ask before every action, or Create drafts without asking (flags, emails and schedules still wait).
- Step 2: Choose Start task. It keeps working if you leave the page.
- Step 3: When a task shows Needs your approval, choose Approve (or Approve and send) or Dismiss for each action. Stop task ends it.
| Action | Runs without asking under "create drafts" |
|---|---|
| Log a complaint, open an investigation, draft the root cause analysis | Yes |
| Run backlog triage, run signal detection | Yes |
| Flag a record, send an email, schedule a recurring agent | No: always waits |
Rule: Nothing is ever signed or closed by Q Agent.
Alerts, rules and watches
The Alerts tab lists active and resolved alerts: Acknowledge, Resolve… with a note, or Ask Q Agent to work this. Rules and watches are checked every 15 minutes.
| Built-in rule | Raised after |
|---|---|
| Possible adverse event without a decision | 24 hours (critical) |
| Complaint awaiting a decision | 5 days |
| Investigation open past its target | 30 days |
| CAPA actions not yet decided | 14 days |
| Batch review exceptions open / batch on hold or returned | 3 / 7 days |
| Process signals not dispositioned | 2 days |
| Prior-approval change without an RA decision | 7 days |
| Record unsigned for a long time | 90 days |
| Agent proposals or Q Agent tasks waiting for approval | 24 / 4 hours |
Also: critical investigation open, validation activities overdue and scheduled agent failed. Watches (up to 15) are plain-language conditions such as "particulates" or "supplier issues". Administrators set who is emailed, from which severity, and escalation of unacknowledged critical alerts under Alert rules; each person sets their own alert emails.