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Qualio
Next-Generation eQMS for Life Sciences

What is Qualio?

Qualio delivers a comprehensive electronic quality management platform tailored for the life sciences sector, supporting companies with document management, risk mitigation, and regulatory compliance. Its intuitive user interface simplifies the process of creating, distributing, and storing quality documents, ensuring organizations can maintain audit readiness, automate training compliance, and manage complex supply chains.

Equipped with AI assistance for core quality processes, Qualio drives operational efficiency and supports continuous improvement. Integrated analytics and seamless connectivity to business-critical applications empower teams to maintain compliance with evolving standards and accelerate routes to market while fostering a culture of quality throughout the organization.

Features

  • AI Assistance: Supports core quality processes with artificial intelligence.
  • Document Management: Build, distribute, and store quality documents centrally.
  • Automated Training Compliance: Standardize and automate employee training records.
  • Change Control: Manage product lifecycle and quality events efficiently.
  • Risk Management: Identify, prevent, and resolve risks proactively.
  • Supplier Management: Centralize and oversee supplier relationships.
  • Analytics Dashboard: Visualize and analyze quality metrics in real time.
  • Audit Readiness: Maintain a continuous state of compliance with regulatory standards.
  • Integration: Connects with key business applications for shared quality data.
  • Scalable User Licenses: Flexible plans accommodate growing organizations.

Use Cases

  • Streamlining quality management for medical device companies.
  • Digitizing and automating pharmaceutical quality processes.
  • Ensuring compliance with FDA, ISO, and ICH regulations.
  • Managing supplier and supply chain risk for biotech firms.
  • Automating employee training and competency tracking.
  • Supporting product lifecycle management from concept to delivery.
  • Facilitating audit preparation and documentation for regulatory bodies.
  • Enabling compliant growth for cannabis and contract research organizations.

FAQs

  • Is Qualio priced as a one-off or recurring cost?
    Qualio offers an annual recurring subscription model to customers.
  • Can user licenses be added as the company grows?
    Yes, Qualio subscriptions can be expanded with additional user licenses at any time.
  • Does Qualio support multiple instances for different sites or companies?
    Multiple instances can be added on the Growth and Scale plans, allowing management of multiple sites or companies.
  • How long does Qualio take to implement?
    With proper preparation, Qualio’s average implementation period is 30–60 days, supported by an expert onboarding team.
  • Is data storage included in the subscription?
    Cloud data storage is included in all Qualio subscriptions, with ISO 27001 certification ensuring security.

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Last 30 Days

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