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AssurX CAPA Software
What AssurX CAPA Software is
AssurX CAPA Software manages corrective and preventive actions from incident intake through investigation, assigned work, effectiveness checks, and closure. CAPAs can begin with audit findings, deviations, complaints, nonconformances, incidents, or risk assessments. Teams can investigate causes with methods including 5 Whys, fishbone diagrams, 8D, and FMEA, then assign owners and due dates, set reminders and escalations, and apply approvals through configurable workflows. Records link CAPAs with related issues, risks, changes, and supporting documents, while maintaining audit trails and controlled records. AssurX says the solution supports FDA requirements and alignment 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 software is offered with cloud or on-premises licensing, and AssurX says the software is identical in either deployment. It also offers an open API and integrations with ERP, PLM, MES, LIMS, CRM, and CMMS systems. Pricing is on request.
Who it suits
It is intended for organizations in regulated environments, including medical device, pharmaceutical, biotech, food, electronics, aerospace, energy, and manufacturing industries. It may suit teams that need traceable corrective-action workflows and controlled records.
What it does well
- Tracks CAPAs through effectiveness checks and closure
- Supports 5 Whys, fishbone, 8D, and FMEA
- Links records to issues, risks, changes, and documents
- Cloud and on-premises licensing options
- Includes an open API
What to know first
- Pricing is available on request
- Technical support is limited to designated company contacts
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| AssurX CAPA Software | Pricing not stated; request a demo | On request |
As assurx.com lists them, read 3 Oct 2026. The maker's own page has the final word.
Getting started
- Visit the AssurX CAPA Software website.
- Request a demo and pricing from AssurX.
- Choose cloud or on-premises licensing.
- Use the open API or listed integrations to connect other systems.
Verdict
AssurX CAPA Software combines structured investigation, configurable action tracking, and traceable records. Its cloud and on-premises licensing options serve organizations managing corrective actions in regulated settings.
Questions
How much does AssurX CAPA Software cost?
Pricing is available on request.
What platforms does it support?
The listed platforms are API, self-hosted, and web.
Can it be hosted in the cloud or on premises?
Yes. AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations.
Which root cause methods does it support?
Listed methods are 5 Whys, Fishbone Diagram, 8D, and FMEA.
Does it support electronic signatures and audit trails?
Yes. The product includes electronic signatures and audit trails; AssurX describes its electronic signatures and audit trails as compliant with 21 CFR Part 11.
What systems does it integrate with?
AssurX says it integrates with ERP, PLM, MES, LIMS, CRM, and CMMS systems, with SAP, Salesforce, Oracle, PTC/Windchill, and ServiceNow among its examples.
Facts from AssurX CAPA Software's own pages
- API
- AssurX says it offers an open API for integrations. · assurx.com, 3 Oct 2026
- Company history
- AssurX says it was incorporated in California in March 2000. · assurx.com, 3 Oct 2026
- Compliance use
- AssurX says its CAPA solution supports FDA requirements and alignment with ISO and GxP requirements; the product page lists 21 CFR Part 820, 21 CFR Part 11, EU MDR, ISO 9001, ISO 13485, and EU IVDR among relevant regulations and standards. · 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
- Founded
- 2000 · assurx.com, 28 Sept 2026
- HIPAA
- AssurX states that it complies with HIPAA regulations and offers a Business Associate Addendum for covered entities. · 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
- 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
- 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
- Issue sources
- CAPAs can originate from audits, deviations, complaints, nonconformances, incidents, and risk assessments. · assurx.com, 3 Oct 2026
- 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
- 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
- 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
- Traceability
- The product links CAPAs to related issues, risks, changes, and supporting documents, with controlled records and audit trails. · 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