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
Related Content
Discover our Life Sciences solutions
Connect with us today!