QT9 QMS vs ZenQMS

QT9 QMS is quality management software for regulated manufacturers, built to automate compliance and quality processes. It includes more than 28 modules, such as document control, audit and risk management, CAPA, inspections and supplier evaluations. Configurable workflows, approval controls, email alerts, reporting, timeline traceability and Excel exports support quality operations. Deployment can be cloud, on-premise or hybrid, with hosting in the U.S. and Europe. QT9 says the browser-accessed system needs no installation and works on PC, Mac and Linux. It describes the software as pre-validated with IQ/OQ/PQ and compliant with FDA 21 CFR Part 11, and lists support for ISO 13485, ISO 9001, EU MDR and AS9100. Security features listed include end-to-end encryption, two-factor authentication and role-based access; the maker also states 99.9% cloud uptime. QT9 QMS integrates with QT9 ERP and supports API connectivity. The company says it has served regulated manufacturers since 2005. Pricing is custom based on users and deployment requirements, and a free trial is available.

ZenQMS is a cloud electronic quality management system for GxP-regulated life sciences organizations. It brings document control, training, CAPAs, deviations, complaints, change controls, audits, supplier management, electronic signatures, risk management and quality reporting into one service. The browser-based application requires no local installation, while Android and iOS access are listed. ZenQMS says its platform is validated for GxP under GAMP 5 Category 4 and FDA system-validation guidance, with documentation for each release. It lists ISO 9001:2015, ISO 27001:2022, SOC 2 Type II and USDM Cloud Assurance, and says electronic records and signatures comply with 21 CFR Part 11. Integrations include Okta, Entra ID, Active Directory and Salesforce. A documented API provides read access to several quality records, and a visual builder creates two-way connections without developers. Human support covers setup through go-live; Documents and Training typically go live in an average of 90 days. Pricing is on request.