Electronic Signatures (E-Signature)
The Calyx RIM Electronic Signature (E-Signature) feature can capture electronic signatures for add, modify, and delete activities for specific entities indicated by system administration. This creates an audit trail event for valid and invalid signatures.
Electronic signature functionality is an optional feature that requires special configuration in Calyx RIM. Contact Client Enablement to enable electronic signatures for your Calyx RIM version.
Add, modify, or delete pages for following entity types:
- Product Family
- Product
- Pharmaceutical Product
- Application
- Event
- Event Country (Event Country Attributes/Status Dates Tab, and Lock/Unlock Event Country for adding pages only)
- Event Closure (Modify Event page, Update Status Wizard, and Update Event-Country Wizard only)
- Sequence (Sequence/Status Dates Tab)
- Registration (Registration Attributes, Copy Package Set Registration Wizard)
- Product Detail Set
- Full Product Presentation (Full Product Presentation Attributes, Copy Full Product Presentation Wizard)
- Registration Attachment (Registration Attachment Attributes, Copy Registration Attachment Wizard)
- Registration FPP Attachment
- References
- Tasks (Task/Sub Task Status Dates Tab)
All wizards except the following can be configured for electronic signature:
- Create Study Report
- Bulk eCTD Import
- Create eCTD
- Create Timeline/Event Plan
- XEVMPD Acknowledgement
- XEVMPD Submission