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
  • Documents distribution
  • Strong security
  • Versioning control
  • Dossier compilation and tracking
  • Electronic signatures
  • Safe archive
  • Easy search
  • Full-text search
  • Audit trail
  • Templates management and approval
  • PDF rendering
  • Watermarking
  • Controlled printing
  • Controlled distribution

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
  • Dossier compilation
  • Integration with eCTD publishing tools
  • Role-based security
  • Electronic signatures (FDA 21 CFR #11)
  • Audit trail
  • Documents Templates management
  • Automated distribution
  • Controlled printing
  • PDF publishing
  • Strong Search and Reporting capabilities
  • Email integration and automatic notifications
  • Search, reporting
  • Electronic archiving

Our clients are using READY! Document management to support various processes:

  • Controlled documents management (SOPs, various specifications)
  • Analytical development
  • Dossiers compilation and lifecycle
  • Labelling management (SPCs, PILs, Artworks)
  • Archiving of records including BMRs, BPRs, CoAsTechnical filed
  • Calibration records
  • CAPA, deviations
  • Contracts, agreements management
  • Invoices management
  • Safe digital archive

READY! Document management is a replacement for shared drives that you are using across your company.

Using READY! is simple and users like it.