ZenQMS

What is ZenQMS?

ZenQMS is a cloud-based quality management system designed specifically for Life Sciences companies, offering an affordable and easy-to-use solution to stay compliant with GxP and ISO requirements. Founded in 2009 by industry veterans, ZenQMS provides a 100 cloud-native application that meets all 21 CFR Part 11/Annex 11 regulations, enabling small to large-scale organizations in the Biotech, Biopharma, CRO, CDMO, Medical Device, Lab, Packaging, Logistics, GxP Software, and Consumer Products sectors to effectively manage their quality processes

Highlights

• Comprehensive document management: Manage the entire document lifecycle from draft to retirement, create approval workflows, collaborate on drafts, and export data in PDF format
• Robust training capabilities: Create course syllabi, assign proficiency tests, log training events, send alerts, and generate reports for managers
• Advanced change control: Define change management processes, manage subtasks, create workflows, provide role-based access, and generate reports
• Integrated issue tracking: Log issues for internal/external sites, assign to investigators, conduct root-cause analysis, and communicate with stakeholders
• Centralized audit management: Manage recurring audits for multiple sites and store documents within a secure portal.