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Conformance1

Conformance1

Tools for conforming to standards, goals and processes

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AssurX QMS

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AssurX is a highly configurable quality management and regulatory compliance platform designed for manufacturing, life sciences, energy, and other regulated industries. The system enables organizations to automate quality processes, manage risks, and streamline workflows while ensuring compliance with industry standards such as ISO, FDA, and OSHA. With both cloud and on-premise deployment options, AssurX provides flexibility for organizations looking to scale their quality management operations efficiently.

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SKU: SOFT-007 Category: Software
  • Description
  • Additional information

Description

Key Features and Benefits

  • Workflow Automation – Customizable workflows help standardize processes for compliance, audits, document control, and CAPA.
  • Regulatory Compliance – Supports compliance with FDA 21 CFR Part 11, ISO standards, OSHA, and industry-specific regulations.
  • Audit Management – Schedules, tracks, and reports on internal and external audits, ensuring transparency and accountability.
  • Risk Management – Identifies and mitigates quality risks through data-driven insights and automated alerts.
  • Supplier Quality Control – Manages supplier relationships with performance tracking, issue resolution, and compliance monitoring.
  • Document & Training Management – Ensures controlled access to documents, tracks revisions, and automates training assignments.
  • Integration Capabilities – Seamlessly connects with Microsoft 365, Salesforce, NetSuite, and other enterprise systems.
  • CAPA Management – Implements corrective and preventive actions efficiently with automated tracking and notifications.

Key Differentiators

  • Highly Configurable – Allows businesses to tailor workflows, reports, and compliance tools without requiring deep coding expertise.
  • Enterprise-Ready – Scalable for organizations of any size, from small teams to global enterprises.
  • Flexible Deployment – Available as a cloud-based or on-premise solution, depending on company requirements.
  • Strong Customer Support – High ratings for responsiveness and implementation guidance.
  • Industry-Specific Solutions – Trusted by life sciences, manufacturing, energy, and heavily regulated sectors.

Additional information

Software Features

Access Controls/Permissions, Alerts/Notifications, Audit Management, Change Management, Complaint Management, Compliance Management, Corrective and Preventive Actions (CAPA), Defect Tracking, Document Coding and Control, ISO Standards Management, Maintenance Management, Quality Control, Risk Management, Supplier Quality Control, Training Management

Available Pricing Models

Per License, Per Year

Free Trial

No

Company Location

California, Morgan Hill, USA

Years in Business

30

Number of Employees

125

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