Quality operations

Quality

Agentic support for quality teams that need faster triage, cleaner evidence, and fewer loose ends — without turning CAPA into chaos.

Map this workflow Governance & validation

GxP quality workflows with reviewable outputs

USDM designs agents to handle bounded quality work: intake, pattern matching, evidence assembly, and follow-up routing while quality owners retain approval authority.

Operating layers

Govern · Prepare · Build · Validate · Scale

Decision rights

Human-owned, evidence-backed.

Concrete workflow example

Deviation triage and CAPA evidence pack

Shorter deviation intake cycles and cleaner CAPA starters without weakening quality ownership.

Inputs

• Deviation intake fields
• prior deviations/CAPAs
• SOPs
• training records
• related audit observations

Agent tasks

• classify the event
• retrieve related records
• draft a source-linked summary
• flag missing evidence
• route to the quality owner

Evidence output

• source links
• draft/reviewer history
• classification rationale
• escalation log

Where agents fit

Useful work, not magical work.

These are the places where a governed agent saves time without taking over the decision.

Deviation intake

Classify events, pull related records, and draft the first-pass summary for review.

CAPA support

Assemble supporting evidence, connect prior issues, and surface likely corrective themes.

SOP and training gaps

Compare a case to current procedures and flag missing instructions or outdated references.

Periodic review

Summarize trends across complaints, deviations, and change records for the quality team.

Use cases

What the team can actually do.

Triage deviation and complaint intake before it reaches a human queue.

Draft CAPA starters with linked evidence and affected records.

Find recurring quality signals across logs, audits, and investigations.

Prepare review packages for quality councils and leadership.

Route missing evidence or approvals back to the right owner.

Human decision points

Humans own the regulated decisions.

impact assessment

disposition

CAPA approval

closure decision

What agents cannot do

No hidden authority.

close a deviation

approve CAPA

change product disposition

replace QA sign-off

Controls and governance

The brakes are part of the design.

If the workflow touches regulated records or operational decisions, the controls need to be visible, testable, and boring.

Only approved record sources are used for retrieval and drafting.

No final disposition, impact assessment, or closure happens without human review.

Every draft links back to source records and reviewer actions.

Thresholds for escalation are defined up front and tested during validation.

Human team role

Domain specialists stay accountable.

Quality leaders define the taxonomy, approve the escalation rules, and sign off on anything that changes disposition, compliance status, or release timing.

Common systems

QMSeQMSdocument controltraining systemsaudit evidence repositories

Other domains