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AssurX CAPA Software

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Spec score 7.6 #11 of 23 in Corrective and Preventive Action Software

What it is

AssurX CAPA Software manages corrective and preventive actions from incident capture through investigation, assigned work, effectiveness checks, and closure. CAPAs can begin with audits, deviations, complaints, nonconformances, incidents, or risk assessments. Structured root-cause methods include 5 Whys, fishbone diagrams, 8D, and FMEA. Configurable workflows handle ownership, due dates, reminders, escalation, and approvals. Records can connect CAPAs with related issues, risks, changes, and supporting documents while preserving controlled records and audit trails. The software includes electronic signatures and a secure, time-stamped archive of record changes. AssurX lists support for FDA requirements and alignment with ISO and GxP requirements, including 21 CFR Part 820 and Part 11, EU MDR, ISO 9001, ISO 13485, and EU IVDR. Cloud and on-premises licensing use the same software, with an open API and integrations for ERP, PLM, MES, LIMS, CRM, and CMMS systems. Pricing is available on request.

Spec sheet

Purpose
The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure.Read 3 Oct 2026 · assurx.com
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.Read 3 Oct 2026 · assurx.com
API
AssurX says it offers an open API for integrations.Read 3 Oct 2026 · assurx.com
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.Read 3 Oct 2026 · assurx.com
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.Read 3 Oct 2026 · assurx.com
Support
Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours.Read 3 Oct 2026 · assurx.com
Founded
2000Read 28 Sep 2026 · assurx.com
Company history
AssurX says it was incorporated in California in March 2000.Read 3 Oct 2026 · assurx.com
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.Read 3 Oct 2026 · assurx.com
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.Read 3 Oct 2026 · assurx.com
HIPAA
AssurX states that it complies with HIPAA regulations and offers a Business Associate Addendum for covered entities.Read 3 Oct 2026 · assurx.com
Hosting
AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations.Read 3 Oct 2026 · assurx.com
Issue sources
CAPAs can originate from audits, deviations, complaints, nonconformances, incidents, and risk assessments.Read 3 Oct 2026 · assurx.com
Root cause analysis
It supports structured root cause analysis, including 5 Whys and fishbone methods.Read 3 Oct 2026 · assurx.com
Traceability
The product links CAPAs to related issues, risks, changes, and supporting documents, with controlled records and audit trails.Read 3 Oct 2026 · assurx.com
Workflow controls
Users can assign and track actions with ownership, due dates, escalation, approval controls, reminders, and configurable workflows.Read 3 Oct 2026 · assurx.com

Plans and prices

AssurX CAPA Software Priced on request Pricing not stated; request a demo Read 3 Oct 2026 · assurx.com

Every AssurX CAPA Software plan and price →

Strong points and limits

Strong points

  • Supports 5 Whys, fishbone, 8D, and FMEA
  • Includes effectiveness checks and electronic signatures
  • Provides audit trails and controlled records
  • Available in cloud or on-premises deployments
  • Offers an open integration API

Limits

  • Pricing is available only on request
  • Designed for regulated organizational environments
  • Deployment and integration scope require planning

Who it suits

AssurX targets organizations in regulated industries such as medical devices, pharmaceuticals, biotech, food, electronics, aerospace, energy, and manufacturing. It suits teams needing controlled CAPA workflows and compliance records.

Verdict

AssurX covers the full CAPA lifecycle with structured investigations, workflow controls, traceability, and compliance-oriented records. Cloud, on-premises, and API options support different deployment arrangements, while pricing requires a request.

Where Specifiction places it

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