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 for electronic signatures.
Our clients are using READY! Document management to support various processes:
Controlled documents management (SOPs, various specifications)
Inspections and audits
Dossiers compilation and lifecycle
Labelling management (SPCs, PILs, Artworks)
Archiving of records including BMRs, BPRs, CoAsTechnical filed
Contracts, agreements management
Safe digital archive
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.
READY! Document management provides:
Automated approval workflow
Dossier compilation and tracking
Templates management and approval
Email integration and automatic notifications
Special focus is on structured documents such as dossiers, modules, agreements, audits, inspections, deviations, complaints, change control, CAPA, and PSMF.
READY! Document management is a replacement for shared drives that you are using across your company.