Quality Document Author

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

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

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.