QMS

Ennov QMS is quality management system software designed for Quality, Regulatory, and Operations teams in regulated life sciences organizations, including pharmaceutical, biotechnology, animal health, and medical device companies. It digitizes and standardizes quality processes, replacing paper forms, spreadsheets, and disconnected tools with controlled workflows, centralized records, and traceable approvals — all in a single, inspection-ready system.

Built on over 25 years of life sciences experience and trusted by more than 450 life sciences companies worldwide, Ennov QMS supports a fully paperless QMS approach. It strengthens governance, improves visibility across quality events, and helps teams maintain compliance as they scale across sites, products, and business partners.

Core Quality Processes Supported

• Deviations and Non-Conformances
• Corrective and Preventive Actions (CAPA)
• Change Control
• Customer Complaints
• Audit Program and Audit Findings
• Impact Assessment
• Product Recall
• Operational Tasks

Key Capabilities

• Graphical workflow designer for building and configuring process flows
• Powerful workflow engine that supports sub-processes
• Visual forms editor with smart forms that adapt to process step and participant
• Manual or automated task execution with automated email notifications, alerts, and escalations
• Real-time monitoring through dashboards and statistics to track pending, overdue, and in-progress activities
• Full-text and metadata-based searching across records
• Configurable processes, metadata, and views to match your SOPs, roles, and terminology
• Integrated work list dashboard for clear ownership and due date visibility
• REST API for advanced integration with external systems

Preconfigured Core Model for Faster Go-Live

• Includes a ready-to-use set of quality workflows based on industry best practices, so teams do not start from a blank slate
• Reduces setup time and supports a consistent rollout across multiple sites
• Workflows can be configured to match internal SOPs, approval paths, roles, and terminology
• Predefined inventory of quality documentation, processes, and workflows aligned to accepted industry standards
• Configuration requires no IT skills, enabling teams to remain fully autonomous

Compliance and Traceability

• Fully compliant with FDA 21 CFR Part 11 requirements, including electronic signatures, audit trail, and records management
• Controlled workflows enforce process steps, route approvals, and capture required evidence at every stage
• Role-based access and reliable traceability for every step and decision
• Supports inspection readiness with faster record retrieval and clearer documentation history
• Helps organizations track status, ownership, cycle times, and recurring quality events through reporting and dashboards

Integration with the Ennov Quality Suite

• Intrinsically connected to Ennov Doc, Ennov's Enterprise Document Management software, for document-controlled processes
• Seamlessly integrated with Ennov Training, an innovative Learning Management solution, for training-related quality workflows
• Connected to Ennov Analytics for data visualization and reporting across quality operations
• Also integrated with Ennov Dossier for broader regulatory and submission management needs

Ennov QMS is 100% web-based and available as either a cloud-based or on-premises deployment, with the flexibility to switch between options at any time. The platform is ISO 9001 and ISO 27001 certified, supports single-tenancy for minimized business interruptions, and offers local data hosting for organizations requiring total data flexibility. With 98.5% of projects delivered on time and within budget, Ennov provides a proven path to scalable, audit-ready quality management for regulated life sciences teams.