No. 3 of 23 ·Corrective and Preventive Action Software

AssurX CAPA Software

Web · Self-hosted · API

Freedom report

One barScore 5.4

Free tierNo free tier on record
Open codeNo open-source code on record
Runs widely1 of 6 device platforms
DocumentedPlans, terms and facts published

AssurX CAPA Software is ranked #3 of 23 in corrective and preventive action software on Freedom251. It runs on API, Self-hosted, Web.

AssurX CAPA Software plans and pricing

All plans

AssurX CAPA Software Not published Pricing not stated; request a demo assurx.com · 3 Oct 2026

Compared on corrective and preventive action software

Root-cause methods: 5 Whys, Fishbone Diagram, 8D, FMEA
Effectiveness checks: Yes
Electronic signatures: Yes
Audit trail: Yes

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The record

Purpose: The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure.
Root cause analysis: It supports structured root cause analysis, including 5 Whys and fishbone methods.
Workflow controls: Users can assign and track actions with ownership, due dates, escalation, approval controls, reminders, and configurable workflows.
Issue sources: CAPAs can originate from audits, deviations, complaints, nonconformances, incidents, and risk assessments.
Traceability: The product links CAPAs to related issues, risks, changes, and supporting documents, with controlled records and audit trails.
Electronic records: The CAPA datasheet describes 21 CFR Part 11 compliant electronic signatures and audit trails, plus a secure, time-stamped archive of changes to electronic records.
Integrations: AssurX says it integrates with ERP, PLM, MES, LIMS, CRM, and CMMS systems, and names SAP, Salesforce, Oracle, PTC/Windchill, and ServiceNow among examples.
Hosting: AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations.
API: AssurX says it offers an open API for integrations.
Security: AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant, and uses 256-bit encryption for data in transit and at rest.
HIPAA: AssurX states that it complies with HIPAA regulations and offers a Business Associate Addendum for covered entities.
Support: Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours.
Intended users: AssurX describes its platform as built for organizations in highly regulated environments and names industries including medical devices, pharma, biotech, food, electronics, aerospace, energy, and manufacturing.
Company history: AssurX says it was incorporated in California in March 2000.

Where it ranks on Freedom251

Best Corrective and Preventive Action Software in 2026#3 of 23

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Sources

assurx.com/corrective-and-preventive-action-softwa· checked 3 Oct 2026
assurx.com/wp-content/uploads/resources/brochures/· checked 3 Oct 2026
assurx.com/integration/· checked 3 Oct 2026
assurx.com/assurx/· checked 3 Oct 2026
assurx.com/assurx-certifications-regulations-stand· checked 3 Oct 2026
assurx.com/technical-support/· checked 3 Oct 2026