READY! Document management and Dossiers compilation
READY! Document management is a complete electronic document management and dossier compilation solution developed for the needs of the pharmaceutical industry.
READY! Document management replaces paper-based collaboration and supports remote work. The electronic signatures functionality is in line with the FDA 21 CFR #11 and Annex 11 regulations.
READY! Document management provides:
Automated approval workflow
Dossier compilation and tracking
Templates management and approval
Special focus is on structured documents such as dossiers, modules, agreements, audits, inspections, deviations, complaints, change control, CAPA, and PSMF.
Computer validation is a standard part of any implementation of READY! document management.
READY! Document management and the READY! Product database are tightly integrated.
The data about medicinal products is being managed in the product database software, and associated documents and dossiers are managed in the document management software. This approach proves to be most effective – it enables step-by-step implementation and keeps the complete integrated solution simple.
Document management functionality
Various attributes, including name, description, product name, various dates
Links to other documents
Links to products in the READY! Product database
Master dossier management
Tracking of dossier modules
Integration with eCTD publishing tools
Electronic signatures (FDA 21 CFR #11)
Documents Templates management
Strong Search and Reporting capabilities
Email integration and automatic notifications
Our clients are using READY! Document management to support various processes:
Controlled documents management (SOPs, various specifications)
Dossiers compilation and lifecycle
Labelling management (SPCs, PILs, Artworks)
Archiving of records including BMRs, BPRs, CoAsTechnical filed
Contracts, agreements management
Safe digital archive
READY! Document management is a replacement for shared drives that you are using across your company.