AssurX CAPA Software

C tier on Corrective and Preventive Action SoftwareScore 6.2 · #9 of 23

Android app: Not listed
Free plan: No
Runs on: api, self-hosted, Web

assurx.com

Summary

AssurX CAPA Software manages corrective and preventive actions from the first incident record through investigation, assigned work, effectiveness checks and closure. CAPAs can begin with audit findings, deviations, complaints, nonconformances, incidents or risk assessments. Root-cause analysis methods include 5 Whys, fishbone, 8D and FMEA. Configurable workflows help assign action owners and due dates, set reminders and escalations, and route approvals. Records can connect CAPAs to related issues, risks, changes and supporting documents, with controlled records and audit trails for traceability. The software includes electronic signatures and effectiveness checks. AssurX says the solution supports FDA requirements and aligns with ISO and GxP requirements; listed standards include 21 CFR Part 820 and Part 11, EU MDR, ISO 9001, ISO 13485 and EU IVDR. The company describes Part 11 compliant signatures and audit trails, plus a time-stamped archive of electronic record changes. Cloud and on-premises licensing are available, with the same software in either deployment. AssurX also offers an open API and says it integrates with ERP, PLM, MES, LIMS, CRM and CMMS systems. Pricing is available on request.

Who it is for

AssurX CAPA Software suits organizations in regulated environments that need to track investigations, corrective actions and effectiveness checks. The company names medical devices, pharmaceuticals, biotech, food, electronics, aerospace, energy and manufacturing as intended industries.

What is good

Tracks CAPAs from incident capture through closure.
Supports 5 Whys, fishbone, 8D and FMEA.
Links actions with risks, changes and documents.
Available through cloud or on-premises licensing.
Includes electronic signatures and audit trails.

What to know first

Pricing is available on request.
No public price is listed.
Support is for designated company contacts.

Verdict

AssurX CAPA Software covers investigation, action tracking, records and effectiveness checks in one CAPA process. Organizations should request pricing and confirm that its listed compliance support fits their requirements.

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, FMEAassurx.com
Effectiveness checks: Yesassurx.com
Electronic signatures: Yesassurx.com
Audit trail: Yesassurx.com

Facts

Purpose: The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure.assurx.com · 3 Oct 2026
Root cause analysis: It supports structured root cause analysis, including 5 Whys and fishbone methods.assurx.com · 3 Oct 2026
Workflow controls: Users can assign and track actions with ownership, due dates, escalation, approval controls, reminders, and configurable workflows.assurx.com · 3 Oct 2026
Issue sources: CAPAs can originate from audits, deviations, complaints, nonconformances, incidents, and risk assessments.assurx.com · 3 Oct 2026
Traceability: The product links CAPAs to related issues, risks, changes, and supporting documents, with controlled records and audit trails.assurx.com · 3 Oct 2026
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.assurx.com · 3 Oct 2026
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.assurx.com · 3 Oct 2026
Hosting: AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations.assurx.com · 3 Oct 2026
API: AssurX says it offers an open API for integrations.assurx.com · 3 Oct 2026
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.assurx.com · 3 Oct 2026
HIPAA: AssurX states that it complies with HIPAA regulations and offers a Business Associate Addendum for covered entities.assurx.com · 3 Oct 2026
Support: Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours.assurx.com · 3 Oct 2026
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.assurx.com · 3 Oct 2026
Company history: AssurX says it was incorporated in California in March 2000.assurx.com · 3 Oct 2026