Ennov Doc for Quality

Ennov Doc for Quality is a full-featured Enterprise Document Management System (EDMS) designed to help highly regulated life sciences organizations manage, share, and track controlled documentation in compliance with GxP and ISO standards. Purpose-built for industries such as pharmaceutical, biotechnology, animal health, and medical device, it addresses the core challenge of maintaining audit-ready, version-controlled documentation across global operations. Trusted by more than 450 life sciences companies worldwide, Ennov Doc for Quality streamlines processes, ensures compliance, and increases operational efficiency.

Managing controlled documents across disparate locations introduces risk, impedes productivity, and makes it difficult to demonstrate proof of document creation, editing, review, approval, and issuance as required by GxP and ISO standards. Ennov Doc for Quality eliminates these inefficiencies by providing a centralized, secure, and scalable platform that gives every employee fast, reliable access to the correct version of any document.

Core Capabilities

• Preconfigured document inventory aligned with the DIA GMP Reference Model, including all required document categories, groups, sub-groups, and artifacts
• Advanced life cycle management with configurable document workflows and types
• Metadata-based document model providing flexibility to adapt to organizational needs without requiring IT skills
• Full-text and metadata-based searching for quick and intuitive document retrieval
• Flexible rights management to control access across users and roles
• Automatic PDF rendering and tag management
• Controlled printing, copy, and paste functionality
• Periodic review, expiration, and archive management
• Integrated change control and robust revision management
• Electronic signature manifestation and audit trail in compliance with FDA 21 CFR Part 11
• Office 365 and Google Drive connectivity to promote collaboration and user adoption

Key Features

• Integrated work list dashboard for streamlined task management
• Configurable document types, workflows, and views
• Automated email notifications to keep stakeholders informed
• Intuitive, user-centric interface designed for ease of adoption
• Integrated PDF Viewer enabling secure read-access to documents from within the application, eliminating the need to download uncontrolled copies
• Composite document support
• 100% web-based platform requiring no MS Office or Acrobat installation on the desktop
• 21 CFR Part 11 compliant, covering electronic signatures, audit trails, and records management

Supported Document Types and Use Cases

• Supports a wide variety of GxP document types including governance, procedures, manufacturing, quality, audit, validation, and packaging documents
• Scalable architecture suitable for large-volume document management in global deployments
• Seamlessly integrates with Ennov Process (Business Process Management), Ennov Dossier (composite document and publishing), and Ennov Analytics (data visualization and reporting) to meet corporate quality standards
• Suitable for regulated industries including pharmaceutical, biotechnology, animal health, and medical device companies

Deployment and Compliance

• Available as cloud-based or on-premises deployment, with the ability to switch between options at any time
• System configuration and management require no IT skills, enabling full organizational autonomy
• Single-tenancy architecture minimizes business interruptions, with the option to host data locally for total flexibility
• ISO 9001 and ISO 27001 certified, ensuring improved security and optimized performance
• Fully compliant with FDA 21 CFR Part 11 requirements for electronic records and signatures