Regulatory
Document Management System

Designed for Regulatory Affairs, operations, and CMC teams, Ennov's document management system (eDMS) helps you control, find, and maintain submission source documents with traceability from draft through approval and archive.

  • Full featured EDMS
  • Configurable doc. life cycles
  • Metadata-based document model
  • Easy and intuitive searching
  • Scalable and secure
  • 21 CFR Part 11 compliant

The Regulatory Document Management Challenge

Ennov Regulatory Documents is a regulatory document management system designed to manage regulatory submission documentation in a single, controlled workspace. The document inventory is preconfigured in alignment with the DIA EDM Reference Model and includes the required domains, groups, sub-groups, and artifacts.

A metadata-based document model provides the flexibility to adapt this structure to your organization’s needs and find the right document quickly without relying on folder hierarchies. Intuitive configuration tools allow administrators to manage document types, properties, views, and lifecycles without needing specialized IT skills.

Built for global teams, Ennov Regulatory Documents combines scalability and security so you can manage large volumes of regulatory documents safely across departments and locations, while maintaining traceability and inspection readiness.

Unified Access to All Documents​

Ennov Regulatory Documents provides a comprehensive solution to managing regulatory submission documentation. The document inventory is pre-configured in alignment with the DIA EDM Reference Model and includes all required domains, groups, sub-groups and artifacts.

Ennov Regulatory Document’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 Regulatory Document’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments.

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Improved Productivity and Efficiency

Ennov Regulatory Documents is a regulatory document management system that helps teams work faster by making it easier to locate, review, and manage submission source documents in one controlled workspace. An intuitive interface and metadata-based search reduce time spent hunting for the correct version, and connectivity with Microsoft 365 and Google Drive supports day-to-day collaboration and adoption.

Teams can view documents directly in the application using an integrated PDF viewer, which helps reduce uncontrolled downloads and keeps work aligned to the current approved file. Templates, revision control, automatic naming and numbering, document relationships, and electronic signature functionality support consistent authoring and review, helping Regulatory Operations teams keep documents on track and aligned to internal standards.

Manage Multiple Business Processes

Ennov Regulatory Documents is a regulatory document management system used to manage a wide range of submission source document types, including Administrative, Quality, Nonclinical, Clinical, and CMC content, along with supporting report components. Its configurability helps teams standardize document structures, lifecycles, and approvals across departments and global locations.

To support regulatory operational excellence, Ennov Regulatory Documents integrates with Ennov Process for workflow automation, Ennov Analytics for reporting and dashboards, and related Ennov modules where needed, while keeping this page focused on document control rather than publishing workflows.

As an added benefit, Ennov Regulatory Documents fully complies with the FDA’s 21 CFR Part 11 requirements, including electronic signatures, audit trails, and records management, making it a strong fit for regulated industries such as pharmaceutical, biotechnology, animal health, and medical device organizations.

Core Capabilities

  • Pre-configured 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

Regulatory Document Management System FAQs

What is a regulatory document management system?

A regulatory document management system is software that helps life sciences teams control regulatory documents across authoring, review, approval, versioning, and archive. It centralizes submission source content, applies structured metadata, and maintains traceability so teams can work consistently across functions and locations.

Regulatory document management software is used to manage submission source documents and supporting records across Administrative, Nonclinical, Clinical, and CMC content. It helps teams avoid version confusion, standardize approvals, and improve visibility into document status so global regulatory submissions stay on track.

Document management software for regulatory affairs is designed around regulated workflows and submission-driven needs, such as controlled lifecycles, traceable approvals, records management, and structured document inventories aligned to regulatory content types. A general EDMS may store files, but it often lacks the regulatory structure and governance needed for submission source documentation.

Look for metadata-based search, configurable document lifecycles, version control, controlled approvals, and a clear audit history. For regulated environments, also evaluate records controls, role-based access, electronic signatures, and how easily the system supports global collaboration across departments and partners.

Metadata makes it possible to find and manage documents by properties like product, country, dossier section, document type, and status, rather than relying on folder hierarchies. In a regulatory document management system, metadata also supports consistent reporting, faster retrieval, and clearer governance across submission source content.

The DIA EDM Reference Model provides a structured way to organize regulatory content using domains, groups, sub-groups, and artifacts. A regulatory document management system that can be preconfigured to this structure helps teams start with a consistent inventory and adapt it to their operating model, improving standardization and retrieval.

Ennov Regulatory Documents supports controlled document lifecycles, including configurable review and approval steps, traceable status changes, and version control. This helps teams reduce manual follow-up, maintain clarity on what is current and approved, and standardize execution across global submission teams.

Ennov Regulatory Documents fully complies with FDA 21 CFR Part 11 requirements, including electronic signatures, audit trails, and records management, making it a strong fit for regulated life sciences teams that need compliant controls and traceable documentation processes.

An integrated PDF viewer and controlled access help teams review content in the application, reducing the need to download uncontrolled copies. Combined with role-based access and traceable actions, this supports safer collaboration and improves confidence that teams are working from the correct, approved version.

Yes. Ennov Regulatory Documents supports connectivity with Microsoft 365 and Google Drive to support day-to-day collaboration while maintaining document control, traceability, and governance within the regulatory document management system.

Discover Our Regulatory Documents and other Regulatory Resources

Case Study: Vetoquinol

[CaseStudy]

Ennov Regulatory Documents

[Product Brief]

The Swiss Army Knife of Compliance: How LENZ Therapeutics Built a Unified Foundation for Commercial Scale

[CaseStudy]

eDMS and IDMP

[White Paper]

More Resources

The Impact of Ennov RIM at Foghorn Therapeutics

Efficient regulatory information management can be complex. Your software shouldn’t be. 

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“It’s really nice to work with a software provider that shows a great deal of innovative spirit, has great ambition and is proactive. Above all, I really appreciate Ennov placing particular emphasis on the customer’s user experience.”

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“With more than 1500 MAAs in 150 countries, we face a real productivity challenge. With Ennov, we have been able to issue 400 dossier in just 18 months. For the first time, our users are experiencing tremendous time savings when locating documents.”

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World-Class Regulatory Content and Information Management

A Regulatory suite with the power and flexibility to support the entire regulatory product lifecycle from the early planning of registration targets through to product retirement.

It is an invaluable solution for regulatory activity planning, product registration management, dossier creation, dossier management and more.

Explore the Regulatory Suite

Why Choose 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

  • 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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