CAPA System Setup

CAPA System Setup

CAPA System Setup

Problem: When nonconformances recur, it is usually because the organization lacks a disciplined, visible way to capture issues, investigate causes, and track actions to closure.

Solution: Our CAPA System Setup packages establish a structured corrective and preventive action process across your sites and functions. We define intake channels, classification rules, workflow stages, roles, and approval thresholds, then align them with your chosen tools. Templates for investigations, action planning, verification, and effectiveness reviews are built into the method. Your teams gain a clear, repeatable way to respond to issues, and leadership gains line of sight to trends, overdue actions, and systemic risks.

* Package pricing is fixed-scope. Changes to scope, additional sites, or additional standards are quoted separately.

* Hourly equivalent row reflects the effective rate if the same work were billed on a T&M basis — packages typically represent 15–25% savings vs. hourly.

* All packages include: project kickoff, stakeholder briefing, deliverable review cycles, and 30-day post-delivery support.

Fixed-Scope Service Packages

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Assess $5K–$12K

Foundation $35K–$55K

Integrated $75K–$120K

Full IMS $120K–$180K

Gap Assessment & Readiness Report

IMS Policy & Scope Design

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Procedures & SOPs

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CAPA System Setup

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KPI & Objectives Framework

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Staff Training — IMS Awareness

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Internal Auditor Training

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Cross-Standard Integration

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AI Governance Module (42001)

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Pre-Certification Audit

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Certification Body Coordination

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90-Day Post-Cert Support

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Typical Timeline

2–4 wks

3–5 mos

6–10 mos

9–14 mos

Hourly Equivalent*

$250/hr

$250/hr

$250/hr

$250/hr

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Share your ISO, risk, or compliance needs, and we will respond promptly with clear next steps, suitable engagement options, and confidential guidance aligned with your current audit timeline.