Qualio

Qualio is a quality management platform built for life sciences companies, combining document control, training management, supplier quality management, design controls, risk management, change control, audit management, and CAPA/NCR workflows in one system. The vendor's site also describes an AI-powered gap analysis feature, called Compliance Intelligence, that maps existing documents against regulatory controls and tracks compliance status across frameworks such as FDA, ISO, MDR and GxP standards.

The product is aimed at medical device, pharmaceutical, biotech, cannabis, software-as-medical-device and contract research organization companies. It is described as a cloud-based software provider, with cloud storage included in the subscription, and the site states it is ISO 27001 certified. Plans are organized around a Foundation tier for teams formalizing quality management for the first time, a Growth tier for organizations managing multiple markets and frameworks, and a Scale tier described as custom for enterprise-grade or multi-site operations.

Pricing is not published on the site; the pricing page asks buyers to request pricing or talk to sales for a tailored quote, and states an implementation fee applies to all plans. The FAQ describes the model as an annual recurring subscription. The site is explicit that some capabilities, such as the Custom Framework Builder, AI Remediation Guidance, Automated Evidence Collection, Continuous Regulatory Monitoring, and Developer API, are only available on the Growth plan, while additional regulatory frameworks and additional edit users carry added fees. Integrations are tiered by plan: Foundation includes core integrations plus a development-tools catalog, while Growth unlocks a fuller catalog including Salesforce, HubSpot and Zendesk.