QMS

ZenQMS is an electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including pharmaceutical companies, CROs, CMOs, and biotech firms. It is designed to support quality operations from preclinical stages through full commercialization, providing a single source of truth for quality processes across the organization.

The platform is validated for 21 CFR Part 11, Annex 11, and relevant GxP and ISO requirements. It is delivered as a pure SaaS solution hosted on Amazon Web Services, with a guaranteed uptime above 99.99% and automatic access to all new releases without IT involvement. All modules are available to all team members from day one, and pricing is structured without per-seat or per-module charges.

Training Module

• Automated reminders notify users of new and past-due training assignments
• Supports creation, completion, and tracking of training events, including SOP reviews and on-the-job training
• Training reports can be pulled by individual, course, or group
• Supports SCORM file uploads for robust training and testing
• Includes expert-authored GMP, GLP, and GCP training content integrated directly into the system

Documents Module

• Tracks the full document lifecycle from draft through retirement
• Supports 21 CFR Part 11 and Annex 11 compliant electronic signatures
• Allows collaborative editing with multiple stakeholders
• Provides granular permissions for document control
• Supports both major and minor document revisions
• Includes a keyword search feature that searches within document content

Change Control Module

• Maintains an accurate record of organizational change
• Allows follow-up tasks to be built directly into change workflows
• Supports detailed permissions for access and escalation
• Automatically enforces closed-loop processes
• Provides an interface designed to be straightforward for regulators and auditors

Issues Module

• Handles CAPAs, deviations, and quality control processes
• Manages customer and product complaints within the same system
• Supports custom, closed-loop workflows configurable for any event type
• Automates issue notifications and investigator assignments
• Provides dashboards to track quality event progress and activity

Audits Module

• Creates and tracks lists of approved suppliers
• Supports supplier management through configurable Qsheets
• Monitors observations through to closure
• Includes an evergreen audit calendar that updates as work progresses
• Generates reports and trends to support risk management feedback loops

Insights Module

• Identifies and analyzes trend data across compliance, training, risks, and other quality areas
• Supports visualization of custom KPIs through Insights Pro
• Allows dashboards to be exported to PDF for sharing
• Supports data export from visualizations in CSV and XLSX formats

ZenSign — External eSignature

• Provides Part 11-compliant eSignature capability for external parties such as clients and vendors
• Integrated directly into ZenQMS without requiring DocuSign or Adobe Sign
• Documents and content remain within the system throughout the signing workflow
• Includes a built-in X.509 certificate

Deployment and Support

• Hosted on a single validated, multi-tenant cloud instance on Amazon Web Services
• Data is backed up hourly, with the option to export the full account as a zip file
• Defined and tested procedures for business continuity are maintained
• Implementation includes personalized onboarding and a guided validation checklist
• Helpdesk access and ZenQMS training materials, including a knowledge base, are included in the annual fee with no additional support charges
• Pricing covers the entire system for all users, with no charges for additional seat licenses, modules, or storage

ZenQMS positions its product roadmap as developed in collaboration with customers. The platform is intended to scale with an organization's growth without requiring additional licensing costs as team size or quality system scope expands.