# Agentic workflow automation for quality teams
Agentic workflow automation uses orchestrated AI agents to carry out routine quality work across your systems: gathering, checking, drafting and chasing. Each agent works inside defined guardrails, can draft but not approve, and hands decisions to your people.
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## How the architecture works
An orchestrator agent plans the task, routes parts of it to specialist agents and assembles the result. The specialists each read the systems they are allowed to: an intake agent on the complaint inbox, an investigation agent on the QMS and batch records, a trending agent on LIMS and MES, a batch review agent on electronic batch records, and a document agent on the document system.

## Routine work agents take on
- Preparing the morning quality huddle: what changed, what needs attention today
- Chasing overdue CAPA actions, with a drafted reminder for each owner
- Assembling the annual product review (APR/PQR) data pack
- Triaging incoming complaints into a drafted record with quoted evidence
- Ranking an open backlog by risk, with the reason for each flag

## The guardrails
- Least-privilege access for each agent
- Draft-only writes: an agent can propose a change, an email or a flag, and cannot make it final
- Human approval gates before anything is sent or recorded
- Every tool call in the audit trail, so an inspector can follow how an output was produced
- Models and prompts under change control

## Your qualified people decide
- Approvals, dispositions and reportability calls stay with qualified people. Agents bring them the work.
- Each agent has a defined intended use that your quality unit has approved.

## Frameworks this work is built to
- 21 CFR Part 11
- EU GMP Annex 11
- EU GMP Annex 22 (draft)
- GAMP 5 (2nd ed.)
- ICH Q9(R1)

## Included
- Orchestrator and specialist agents
- Least-privilege access
- Draft-only writes
- Human approval gates
- Audit trail

## Questions about agentic workflow automation

### What is an AI agent in a quality system?

A software component that uses an AI model to plan and carry out a bounded task with tools: reading records, searching documents, drafting text. In a quality system each agent has a defined intended use, only the access it needs, and no authority to approve.

### Can an agent change or approve a GxP record?

No. Agents read and draft. Anything that would change a record, send a message or record a decision waits for a qualified person to review and approve it, and the approval is attributed to that person.

### How is this different from robotic process automation?

Robotic process automation replays fixed steps in fixed screens. An agent can read unstructured records, decide which sources it needs and write a sourced draft. That flexibility is why it is bounded by access limits, draft-only writes and approval gates.

### Which task should we automate first?

One that is routine, well understood and low risk if a draft is wrong: huddle preparation and overdue chasing are common starting points, because a person reads the result before acting on it.

## Related services
- QMS digitizationConfigured on the platform that fits your size and product type.
- AI-assisted investigationsThe AI drafts. Your investigators and QA decide.
- Connected quality dataYour QMS linked to plant and lab systems for trending, recurrence detection and earlier signals.
- Validation of AI-enabled systemsRisk-based validation following GAMP 5 (Second Edition) and computer software assurance principles, documented for inspection.

## Talk it through with someone who has run a plant
Bring your backlog, your systems map or one investigation that keeps coming back. We will tell you plainly what we would do and what we would leave alone.
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In the first meeting we cover
- Your current QMS and how it connects to MES, LIMS and ERP
- Where deviations, CAPAs and change controls slow down
- Whether a readiness assessment makes sense, and what it would cover

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Source: https://qlogix.ai/services/agentic-workflow-automation
QLogix · contact@qlogix.ai · +17146639012