Qualio
Qualio offers a cloud-based Quality Management System (eQMS) tailored for life sciences, supporting compliance with various standards and regulations and providing a range of features and integrations.
Services
Qualio offers a comprehensive cloud-based Quality Management System (eQMS) tailored for life sciences. Their platform includes features for document management, design controls, risk management, training management, change control, audit management, CAPA management, supplier management, and quality analytics. The service aims to help companies streamline their quality processes and ensure compliance with various standards and regulations.
Industries Served
Qualio provides solutions for diverse industries, including medical devices, pharmaceuticals, biotech, cannabis, and software as a medical device (SaMD). Their platform is designed to support the specific needs of each industry, ensuring that companies can maintain regulatory compliance and manage quality processes effectively.
Regulatory Compliance
Qualio supports compliance with multiple standards and regulations crucial for life sciences. These include FDA 21 CFR Part 11, ISO 13485, ICH Q10, GxP, and FDA 21 CFR Part 820. The platform's features help companies ensure they meet these regulatory requirements seamlessly.
Integrations
Qualio offers integrations with several key business applications, enhancing its functionality and ease of use. Integrations include Asana, Azure DevOps, Jira, ComplianceWire, TestRail, Google Suite, Okta, Salesforce, and OneDrive. Additionally, Qualio provides a public API to facilitate seamless integration with other systems, making it highly adaptable to various business needs.
Certifications and Reviews
Qualio is ISO 9001 and ISO 27001 certified, demonstrating its commitment to quality and information security management. The platform has received positive reviews on platforms like G2, Capterra, GetApp, and SoftwareAdvice, with users often praising its ease of use and comprehensive features. Qualio supports a flexible pricing model to cater to the specific needs of life science companies, aiding in its high user satisfaction.