Regulatory Content Management

R&DExpert™ promotes cross-functional collaboration and establishes a single authoritative document asset repository, covering all document management functionalities, including template management, workflows, advanced rendering and permissions. 

Benefits

Common Standards

Establishing common standards through pre-configured types of documents 

Ease of Authoring

Easing the authoring of complex documents through use of compound documents structures

Impact Assessments

Facilitating impact assessments through powerful where-used functionalities 

R&DExpert™ Features

  • Document import, creation and classification
  • Offline and collaborative editing (integration with Office365)
  • Template management
  • History tracking (audit trail)
  • Role-based access control
  • Dynamic version control with configurable versioning policy
  • Use of compound documents
  • Managing document relations
  • 21 CFR Part 11 / EU Annex 11 compliance including electronic signature
  • Submission-ready document renditions
  • Lifecycle automation and control for basic and compound documents
  • Collaboration, business process monitoring and control
  • User and task management
  • Reminders, notifications and deadlines
  • Wizards for document management
  • Inline content annotations

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