Ennov Quality Documents
Quality Document Management Software for GxP Teams
Designed for regulated quality environments, Ennov’s quality document management software centralizes controlled documents, streamlines review and approval workflows, and supports inspection readiness with traceability across the document lifecycle.
- Full featured EDMS
- Configurable document life cycles
- Metadata-based document model
- Easy and intuitive searching
- Scalable and secure
- 21 CFR Part 11 compliant
The Quality Document Management Challenge
Managing and sharing controlled documents effectively and securely in a global environment is a challenge. Highly regulated companies like those in the biopharmaceutical industry are required to manage and track documentation per GxP and ISO standards. These quality standards require proof of document creation, editing, review, approval and issuance.
Storing documents on file shares across disparate locations is inefficient, impedes productivity and introduces risk. Personnel often needlessly spend time hunting for the correct version of a document – prolonging their tasks at hand and increasing their frustration.
If these challenges sound all too familiar, our comprehensive full-featured Enterprise Document Management System, Ennov Quality Documents, is a quality management software that can help you streamline processes, ensure compliance and increase operational efficiency.
Unified Access to Quality Documents
Ennov Quality Documents provides a comprehensive solution to managing GxP documentation. The document inventory is pre-configured in alignment with the DIA GMP Reference Model and includes all required document categories, groups, sub-groups and artifacts.
Ennov Doc’s metadata-based document model provides the flexibility to adapt this model to your company’s organizational needs. Our intuitive suite of design utilities allow administrators to configure and manage the system without needing IT skills.
Ennov Doc’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments.
Improved Productivity and Efficiency
Ennov Doc’s intuitive user interface and efficient search capabilities allow every employee to quickly locate and access the documents they require. The user-centric design and connectivity to Microsoft Office 365 and Google Drive improves user adoption, promotes collaboration and accelerates your return on investment.
Ennov Doc provides instant access to documents without requiring MS Office or Acrobat to be installed on the desktop. The integrated PDF Viewer increases security by providing read-access to documents from within application – eliminating the need to download an uncontrolled copy.
Automatic periodic reviews, integrated change control, robust revision management, controlled printing and electronic signature manifestation functionality make Ennov Quality Documents the perfect solution to ensure GxP and ISO compliance.
Manage All Quality Documents
Our customers use Ennov Doc Quality to support a wide variety of GxP document types including governance, procedures, manufacturing, quality, audit, validation, packaging and more. Ennov Doc’s high degree of configurability and seamless integration with our Business Process Management System (Ennov Process), our composite document and publishing system (Ennov Dossier) and our data visualization and reporting tools (Ennov Analytics) allows them the flexibility to meet their corporate quality standards.
As an added benefit, Ennov Doc fully complies with FDA’s 21 CFR part 11 requirements (electronic signature, audit trail, records management), making this quality document management software a perfect fit for regulated industries such as pharmaceutical, biotechnology, animal health, medical device and others.
Core Capabilities
- Preconfigured document inventory
- Advanced life cycle management
- Flexible rights management
- Automatic PDF rendering and tag management
- Full-text and metadata based searching
- Controlled printing, copy and paste
- Periodic review, expiration and archive management
- Office 365 and Google Drive connectivity
Key Features
- Integrated work list dashboard
- Configurable document types, workflows and views
- Automated email notifications
- Intuitive user interface
- Integrated PDF Viewer
- Composite document support
- 21 CFR Part 11 compliant
- 100% web-based
Quality Document Management Software FAQs
What is quality document management software?
Quality document management software helps regulated organizations control GxP documents across creation, review, approval, versioning, periodic review, and archive. It centralizes controlled documents in one system with traceability so teams can maintain inspection readiness and reduce version confusion.
What is quality document management software used for?
Quality document management software is used to manage controlled document lifecycles and prove that documents were created, edited, reviewed, approved, and issued according to defined quality processes. It supports quality operations by improving retrieval, standardizing workflows, and reducing manual effort tied to document control.
How is quality document management different from a general document system?
A general document system stores files. Quality document management software supports GxP execution by enforcing controlled lifecycles, traceable approvals, version control, and audit-ready history. It is designed for regulated teams that must demonstrate document control during audits and inspections.
What should I look for in quality document management software for GxP and ISO?
Look for configurable document lifecycles, metadata-based search, role-based access, version control, and clear audit history. For GxP and ISO environments, also prioritize periodic review management, change control support, controlled printing, and electronic signatures where required.
What is the DIA GMP Reference Model, and why does it matter?
The DIA GMP Reference Model provides a structured way to organize quality documentation into categories, groups, sub-groups, and artifacts. A system that can be preconfigured to this model helps teams start with a consistent structure and adapt it to their organizational needs, improving standardization and retrieval.
How does quality document management software improve inspection readiness?
Inspection readiness depends on document control and traceability. Quality document management software supports this by maintaining controlled versions, approval history, and records controls, so teams can show who approved what and when, and retrieve the correct version quickly during audits.
What types of documents can Ennov Quality Documents manage?
Ennov Quality Documents supports many GxP document types, including governance documents, procedures, manufacturing records, quality records, audit documentation, validation documents, and packaging-related documentation. The system is configurable, so teams can align document structures and metadata to their quality operating model.
How does Ennov Quality Documents support periodic reviews and change control?
Ennov Quality Documents supports periodic review cycles and controlled document updates through configurable lifecycles and workflows. This helps teams keep documents current, route changes for the right approvals, and maintain a traceable history of updates over time.
Does Ennov Quality Documents comply with FDA 21 CFR Part 11?
Yes. Ennov Quality Documents fully complies with FDA 21 CFR Part 11 requirements, including electronic signatures, audit trails, and records management, supporting regulated teams that need compliant controls and traceable documentation processes.
How does metadata-based search help quality teams?
A metadata-based approach lets users find documents by properties like document type, product, site, process area, status, and effective date, rather than relying on folder hierarchies. This improves retrieval speed, reduces time spent hunting for the correct version, and supports more consistent reporting and oversight.
Discover Our Quality Resources
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[Read the Article]
A blueprint for scalable QMS
[Practical Guide]
Design, scale, and validate with confidence
[White Paper]
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[Blog Article]
AI-powered training compliance
[Product Demo]
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with a paperless, audit-ready quality ecosystem that scales with growth and accelerates new site integration.
How Rhenus Standardized Quality Across Borders
Turning Quality into a Growth Engine
How a Pre-Commercial Biotech Went
from Paper-Based to Market-Ready
A unified digital system replaced binders and manual approvals, improving traceability and building a scalable, audit-ready quality foundation before launch.
Pharmacosmos Case Study
“It makes our daily handling and signing of documents much faster, reduces the use of paper and eliminates signing documents by hand.”
Flemming Simonsen,
Director, GxP System Compliance Pharmacosmos
How to Build a Strong Foundation for Commercial Growth
Learn how unifying Quality, Regulatory, and TMF archive management into one system eliminated ongoing CRO fees and helped teams move faster without adding headcount.
How IUCT Oncopole Built an Audit-Ready Quality Culture
Transforming complex oncology workflows into a centralized quality system for 600+ healthcare professionals
Building a Complete Research Operations Platform
How an academic research group replaced fragmented, outdated tools with a self-configured, unified platform covering study management, quality, eTMF, and analytics.
A Comprehensive QMS to Improve Efficiency and Ensure Compliance
Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best practices.
This allows your organization to get your QMS system into production and begin realizing your return on investment more quickly. Ennov Quality, like all Ennov solutions, is easy to configure and requires no IT skills.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
- Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
- Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
ISO 9001 & 27001 Certified
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