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AssurX CAPA Software
What it is
AssurX CAPA Software manages corrective and preventive actions, taking records from incident capture through investigation, assigned actions, effectiveness checks and closure. Teams can open CAPAs from audits, deviations, complaints, nonconformances, incidents and risk assessments. Structured root-cause methods include 5 Whys, fishbone diagrams, 8D and FMEA. Configurable workflows track action owners and due dates, with reminders, escalations and approval controls. CAPAs can be linked to related issues, risks, changes and supporting documents, with controlled records and audit trails. 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 datasheet describes compliant electronic signatures and a time-stamped archive of changes to electronic records. Cloud and on-premises licensing options use the same software. An open API and integrations with ERP, PLM, MES, LIMS, CRM and CMMS systems are also listed. Pricing is available on request.
For and against
For
- Supports 5 Whys, fishbone, 8D and FMEA methods.
- Tracks action owners, due dates and approvals.
- Links CAPAs with related issues, risks and documents.
- Offers cloud and on-premises licensing.
- Includes electronic signatures and audit trails.
Against
- Pricing is available only on request.
- Deployment choices are cloud or on-premises licensing.
- Technical support is for designated company contacts.
The verdict
AssurX CAPA Software covers the CAPA lifecycle with configurable controls, cause-analysis methods and linked records. Organizations should request pricing and confirm the deployment and support arrangement that fits their teams.
Who it suits
The software is intended for organizations in regulated environments, including medical devices, pharma, biotech, food, electronics, aerospace, energy and manufacturing. It may suit teams that need structured CAPA workflows and traceable records.
Plans and prices
AssurX CAPA Software
Pricing not stated; request a demo
Read 3 Oct 2026 · assurx.com
On the record
- API
- AssurX says it offers an open API for integrations.assurx.com · read 3 Oct 2026
- Company history
- AssurX says it was incorporated in California in March 2000.assurx.com · read 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 · read 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 · read 3 Oct 2026
- HIPAA
- AssurX states that it complies with HIPAA regulations and offers a Business Associate Addendum for covered entities.assurx.com · read 3 Oct 2026
- Hosting
- AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations.assurx.com · read 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 · read 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 · read 3 Oct 2026
- Issue sources
- CAPAs can originate from audits, deviations, complaints, nonconformances, incidents, and risk assessments.assurx.com · read 3 Oct 2026
- Purpose
- The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure.assurx.com · read 3 Oct 2026
- Root cause analysis
- It supports structured root cause analysis, including 5 Whys and fishbone methods.assurx.com · read 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 · read 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 · read 3 Oct 2026
- Traceability
- The product links CAPAs to related issues, risks, changes, and supporting documents, with controlled records and audit trails.assurx.com · read 3 Oct 2026
- Workflow controls
- Users can assign and track actions with ownership, due dates, escalation, approval controls, reminders, and configurable workflows.assurx.com · read 3 Oct 2026
