Document management and Dossiers compilation

READY! document management configuration has been developed for the needs of the pharmaceutical industry.

Specific configuration of READY! replaces manual paper-based and email exchange of documents.

Our clients are using READY! to streamline various processes:

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

Implementation of this processes is based our predefined process templates.

The electronic signatures functionality is in line with the FDA 21 CFR #11 and Annex 11 regulations for electronic signatures.

READY! document management configuration provides:

  • Automated approval workflows
  • Documents distribution
  • Strong security of documents
  • Role based user access
  • 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
  • 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! is a replacement for shared drives that you are using across your company.

Using READY! is simple and users like it.