Tech riderRev. 3 Oct 2026
AssurX CAPA Software
- 1Runs onAPI, self-hosted, Web
- 2CostsNot stated by the maker
- 3Root-cause methods5 Whys, Fishbone Diagram, 8D, FMEA
- 4Effectiveness checksYes
- 5Electronic signaturesYes
- 6Audit trailYes
5 lines stated Written from the maker's own pages: assurx.com
Overview
AssurX CAPA Software is ranked #10 of 23 in corrective and preventive action software on Specifiction. It runs on API, Self-hosted, Web.
AssurX CAPA Software plans and pricing
All plansCompared 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
Company
- Founded
- 2000assurx.com · 28 Sept 2026
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Where it ranks on Specifiction
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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