Qualio is a cloud-based quality management software platform tailored for life sciences companies in highly regulated industries such as medical devices, biotechnology, and pharmaceuticals. It aids in simplifying compliance with stringent industry standards like FDA 21 CFR Part 820 and ISO 13485, crucial for ensuring product safety and efficacy. With features such as document control, training tracking, NC/CA management, electronic signatures, audit trails, risk management tools, and SOP creation support, Qualio provides a comprehensive solution for maintaining quality and regulatory compliance. Its user-friendly interface fosters real-time collaboration among team members across different locations.
Founded by Robert Fenton and Damien Murtagh in 2012 to meet the specific needs of highly regulated life sciences industries, Qualio addresses challenges related to quality and compliance. Both founders leveraged their backgrounds in technology and business to develop a platform that streamlines compliance processes while enhancing quality control measures. Their commitment to innovation has driven the continuous evolution of Qualio since its inception.
Qualio competes with other providers like MasterControl, Greenlight Guru, and Sparta Systems but stands out due to its specialized focus on specific industry standards such as FDA 21 CFR Part 820 and ISO 13485. The platform's features include document control, employee training tracking, NC/CA management tools designed specifically for the life sciences sector's unique needs. Its user-friendly interface supports real-time collaboration among dispersed team members which enhances communication efficiency within organizations. These competitive advantages position Qualio as a robust solution suited for maintaining quality while ensuring regulatory compliance in the life sciences industry’s stringent environments.