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Structures quality evidence, corrective actions, owners and effectiveness checks.
Quality management · v3.2.0

CAPA Evidence Operator

A controlled CAPA working file with evidence, hypotheses, actions, owners and effectiveness checks.

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Problem this skill solves

CAPA files weaken when evidence, hypotheses, containment, corrective actions and effectiveness checks are mixed together or poorly traced.

Best moment to use it: Use it to prepare or repair a CAPA record that must remain auditable across investigation, action and effectiveness review.

How it works

What the agent actually does

  1. 01

    Structure

    Organizes the issue, scope, evidence, containment and applicable quality requirements.

  2. 02

    Test

    Separates confirmed causes from hypotheses and links actions to the conditions they address.

  3. 03

    Verify

    Defines owners, due dates, effectiveness evidence and quality-unit review gates.

What you receive

Concrete, reviewable outputs

  • Controlled CAPA working file
  • Evidence and hypothesis register
  • Action-to-cause traceability matrix
  • Effectiveness-check plan
Example in practice

A repeat deviation is separated into verified observations and three hypotheses, with tests and action owners defined before quality review.

What it does not do

It does not determine root cause without evidence, approve CAPA, release product or replace quality-unit authority.

Buyer

Quality, medical-device and pharmaceutical teams

Business result

A controlled CAPA working file with evidence, hypotheses, actions, owners and effectiveness checks.

Release stage

Validation release

Stripe Checkout remains disabled until payment, webhook and fulfillment configuration are verified. Final scope and delivery are confirmed before activation.

Purchase path

Pilot request

Pricing

$599 USD

Individual license · or $249/month with updates.

Compatibility

Agent Skills-compatible workspaces · ChatGPT · Codex · OpenAI API workflows

Trust record

Version 3.2.0

Last catalog verification: 2026-08-30. Evidence-first workflow with explicit human approval boundaries.

Commercial terms

Clear license.
Human accountability.

Individual commercial-use license; redistribution and resale require a separate agreement.

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