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.
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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.