Qualio favicon Qualio VS QEdge eQMS favicon QEdge eQMS

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.

QEdge eQMS

QEdge eQMS is an industry-ready, GxP-compliant enterprise quality management system tailored for the pharmaceutical and life sciences industries. This platform centralizes essential quality processes, such as change control, deviation, investigation, CAPA, market complaint management, and vendor qualification on a single, configurable dashboard. The system provides seamless integration with ERP, LIMS, and MES solutions, optimizing organizational workflows while supporting regulatory compliance and robust audit trails.

Backed by over 25 years of domain expertise, QEdge eQMS leverages advanced technology including generative AI for analytics, customizable data-driven dashboards, and automated document management. Its features enable efficient handling of documentation, streamlined audit management, effective training scheduling, automated PQR/APQR generation, and cloud readiness to enhance operational efficiency and regulatory adherence for life science enterprises.

Pricing

Qualio Pricing

Contact for Pricing

Qualio offers Contact for Pricing pricing .

QEdge eQMS Pricing

Contact for Pricing

QEdge eQMS offers Contact for Pricing pricing .

Features

Qualio

  • 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.

QEdge eQMS

  • Configurable Workflows: Adaptable modules to fit various business scenarios and regulatory needs
  • Automated Document Management: Centralized control of manuals, SOPs, BMRs, and work instructions
  • AI-Enabled Analytics: Advanced data analysis and reporting powered by generative AI
  • Comprehensive Training Management: Auto-scheduling, certification, and compliance tracking
  • Vendor Qualification: Streamlined communication and approval management with vendors
  • Process Control: Unified change control, CAPA, deviation, investigation, and risk assessment
  • Audit Management: Detailed audit trails and compliance support for regulatory inspections
  • Seamless Systems Integration: Compatible with ERP, LIMS, and MES platforms
  • User-Driven Dashboards: Customizable and interactive reporting features
  • Cloud-Ready Solution: Secure, scalable cloud infrastructure ensuring availability and security

Use Cases

Qualio 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.

QEdge eQMS Use Cases

  • Automating quality event management for pharmaceutical manufacturing
  • Centralizing compliance documentation and issuance
  • Scheduling and tracking workforce training and certifications
  • Managing change control and deviation workflows for life science operations
  • Generating regulatory-compliant product quality review reports
  • Facilitating vendor qualification and document exchanges
  • Conducting risk assessments and audit management with robust traceability

FAQs

Qualio 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.

QEdge eQMS FAQs

  • Is QEdge eQMS suitable for regulatory compliance?
    Yes, QEdge eQMS is designed to comply with international regulatory requirements such as 21 CFR Part 11, EU, and MHRA regulations.
  • Can QEdge eQMS integrate with existing ERP or LIMS systems?
    Yes, QEdge eQMS offers seamless integration with ERP, LIMS, and MES platforms to centralize data and streamline workflows.
  • Does QEdge support automated document issuance and control?
    Yes, QEdge includes automated document management features for issuing, tracking, retrieving, and controlling compliance documents.
  • What kind of analytics capabilities does QEdge provide?
    QEdge leverages generative AI to offer advanced analytics, customizable dashboards, and automated report generation for quality management.

Uptime Monitor

Uptime Monitor

Average Uptime

99.7%

Average Response Time

181 ms

Last 30 Days

Uptime Monitor

Average Uptime

99.56%

Average Response Time

1536.8 ms

Last 30 Days

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