Quality Document Author

The Quality Document Author Role provides enterprise-wide collaboration that automates the authoring, reviewing, releasing and publishing of controlled documents, while ensuring regulatory compliance.

The ENOVIA 3DEXPERIENCE Quality Document Author drives efficiency and compliance by enabling users to create and manage a robust controlled documentation process with enterprise-wide change control. Designed to help regulated industries and maintain compliance while enhancing productivity.

Quality Document Author is a collaborative, enterprise-wide document control solution that manages authoring and control of the document lifecycle. Quality Document Author uses a common change process leveraging change impact analysis, where used functionality across all domains, while maintaining a traceable reliable audit trial of changes.

Quality Document Author controls changes by identifying ownership of the change, allows for review and approval of the changes by stakeholders (supports CFR 21 Part 11) preventing changes that could adversely affect product quality or conflict with requirements while ensuring appropriate training is complete when product specifications and processes are modified. Periodic reviews are supported to ensure on going compliance and accuracy of the document intended usage. Quality Document Author enables distribution of controlled documents with supported controlled printing and management of hard copies distribution.

ENOVIA Quality Document Control

ENOVIA Quality Document Control

Quality Document Author Benefits

Connect, Collaborate and Innovate Across Global Domains

Centralize corporate document control and visibility, while enhancing local productivity with a solution that unifies document creation, approval, change control, and retrieval and provide flexibility in workflows and document lifecycles.

Aggregate change Implementation Content

Assess the impact of product and process changes across functions with traceable content for quality audits.

Govern Enterprise-wide Training

Assure that training on new or changed product specifications and processes are read and understood.

Enforce a Standardized Change of Control Methodology Across the Enterprise

Provide a mechanism to automate the change control process for assessing, planning, implementation, verification and closure to enhance production and increase product quality.

Automate Workflow Processes

Assign necessary reviewers for greater efficiency throughout the organization, more informed decision-making and reduced cost of compliance.

ENOVIA SOP Quality Template

ENOVIA SOP Quality Template

Quality Document Author Highlights

  • Connect, collaborate and innovate seamlessly across global domains with a single change control process.
  • Increase efficiency: Accelerate automated workflows efficiency, communication and decisions making between multidisciplinary teams.
  • Audit readiness: Detailed audit trails, content organization, and powerful search facilitates better audits and inspections.
  • Defined training processes with clear views of training status.
  • Support for Electronic Signature – CFR 21 Part 11.
Related Software


ENOVIA PLM software is the product lifecycle management backbone of the Dassault Systèmes portfolio, used by many of the world's largest and most technically advanced manufacturing enterprises to streamline their organization.



Connect with other 3DEXERIENCE roles and take advantage of the virtual twin for the entire enterprise

Digital Twin autonomous vehicles
Scalable Architecture

Natively built for the cloud and also available on premises, ENOVIA spans the full spectrum from very small clients to customers with thousands of users.

This ‘infinite’ scalability is driving exponential adoption across all engagement models, letting clients plan and sustain their growth and address their evolving business needs.

3DEXPERIENCE Cloud Computing
Cloud Collaboration

Cloud is driving the ability to scale, drastically reducing the distance and time between technology decision and value realization, letting companies take continuous advantages of enhancements & scope extension every 8 weeks. Cloud adoption is now a reality for all sizes of clients.

ENOVIA Connecting PLM
Go beyond PLM

ENOVIA powered by the 3DEXPERIENCE platform goes beyond PLM, connecting people, ideas and data from across the value network into a single collaborative environment that transforms the way you do business.


The 3DEXPERIENCE platform provides a Safe, Social, Connected, Informed and Structured environment for team leaders, project managers and other professionals who want to manage data on the cloud and collaborate without constraints.

Safe: Customer controlled access. Transparent cloud backup. Encrypted communication protocols. Data always safe-no overwrite, no loss of data.

Social: Integrated structured and unstructured collaboration tools enabling social innovation. Collaborate on product design or engage with your stakeholders early in product development.

Connected: Every user always connected to a single, common database. Access data anywhere, anytime, on any device. Review and markup models.

Informed: Choose from the widget library, Create and share Dashboards. Get the latest information about your product development. Always have access to your latest data.

Structured: Zero overhead data management - store and manage data across collaborative spaces, share information in communities. Find indexed data faster by using tags, custom search, etc.

Interested in the Quality Document Author 3DEXPERIENCE Role?

Contact us and get your questions answered today.

US 440.257.7460 | UK 01926.333777