EDMS & Document Life Cycle, Formal Documents, Standard Operating Procedures, Working Instruction, Change Request Recording and Training Material Archiving.
• Document's & SOP Life Cycle (Workflow, Versioning, Status, Working Areas, ...)
• SOP Distribution & Controlled Printing
• Change Request
Document Management System to collect, archive & organise the documents used to prepare the Registration Dossier.
• Project Control - Project Portfolio
• Document Life Cycle & Workflow Management
• Dossier Life Cycle & Dossier Variation Management
• Template Management for Dossier Harmonisation
• Preparation of a “Virtual” Dossier Structure for Publishing Tool Interface
• Native Interface for Publishing tool Integration for CTD & eCTD
“Packaging Material Document Management“ to manage Packaging Specification Doc.
• To share registration Dossier Contents for Packaging Material
• To Archive Artworks (Document Management Module to Archive leaflets, blister
and carton's documentation, etc.)
Archiving Clinical Data & Adverse Event, managing data coming from Clinical Studies & Adverse Events Systems.
• Archiving Clinical Study Data
• Adverse Event Submission Archiving |
