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Conformance1

Conformance1

Tools for conforming to standards, goals and processes

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Qualio

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Qualio is a cloud-based quality management system (QMS) designed for life sciences companies looking to streamline compliance with FDA, ISO, and GxP regulations. It centralizes document control, audits, CAPA, and risk management while ensuring transparency through automated workflows and audit trails. The platform serves as a single source of truth for all quality-related activities, helping organizations improve efficiency and compliance readiness.

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SKU: SOFT-009 Category: Software
  • Description
  • Additional information

Description

Key Features and Benefits

  • Regulatory Compliance – Supports FDA, ISO 13485, GxP, and other regulatory requirements.
  • Document & Change Management – Centralized repository with version control, approval workflows, and audit trails.
  • Training Management – Tracks employee training progress and compliance requirements.
  • Supplier Quality Control – Manages supplier performance with configurable workflows and approval processes.
  • Risk & Audit Management – Supports proactive risk assessments and ensures audit readiness.
  • CAPA & Non-Conformance Tracking – Automates corrective and preventive actions for quality events.
  • Customizable Workflows – Adapts processes to match specific quality and compliance needs.
  • Integrations – Connects with Jira, Asana, Confluence, Okta, and TestRail for seamless workflow management.

Key Differentiators

  • Life Sciences Focus – Tailored for medical devices, biotech, pharmaceuticals, and contract research organizations.
  • Cloud-Based & Scalable – Supports remote teams with real-time access to quality data.
  • Continuous System Improvements – Regular updates based on customer feedback enhance the user experience.
  • User-Friendly Interface – Simplifies quality management tasks for both small and large organizations.
  • Dedicated Customer Support – Highly rated customer service with responsive assistance.

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, Document Management, Equipment Management, Inspection Management, ISO Standards Management, Maintenance Management, Quality Control, Risk Management, Supplier Quality Control, Task Management, Training Management, Workflow Management

Available Pricing Models

N/A

Free Trial

No

Company Location

California, San Francisco, USA

Years in Business

10

Number of Employees

125

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