Document management and Dossier compilation
READY! Document management functionality has been developed for the specific needs of the pharmaceutical industry.
Document management and Dossier compilation
READY! replaces the shared drives traditionally used across your organisation.
READY! eliminates manual paper-based processes and email exchanges, streamlining document management.
Its user-friendly interface is highly appreciated by our users.
Our clients are using READY! to streamline various processes.
- Controlled documents management
(SOPs, specifications) - CAPA and deviations
- Inspections and audits
- Dossier compilation and lifecycle management
- Labelling management
(SPCs, PILs, Artworks)
- Calibration records
- Analytical procedures
- Contracts and agreements management
- Invoices management
- Safe digital archive
- Archiving of records including BMRs, BPRs, CoAs, and technical files
Implementation of these processes is based on our predefined process templates.
The electronic signatures functionality is compliant with FDA 21 CFR Part 11 and EU Annex 11 regulations.
READY! Document management funcitonality provides:
- Automated approval workflows
- Document distribution
- Strong document security
- Role-based user access
- Version control
- Dossier compilation and tracking
- Electronic signatures
- Secure document archive
- Easy search capabilities
- Full-text search functionality
- Audit trail
- Templates management and approval
- PDF rendering
- Watermarking
- Controlled printing
- Controlled document distribution
- Email integration and automatic notifications
A special focus is placed on structured documents such as dossiers, ePI, modules, agreements, audits, inspections, deviations, complaints, change control, CAPA, and PSMF.
READY! CONFIGURATIONS
Follow a manual added link
READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
Follow a manual added link
Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
Follow a manual added link
Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
Follow a manual added link
Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
Follow a manual added link
Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
Follow a manual added link
Development
Track milestones and store documents created in the development of a new medicine.
Follow a manual added link
Quality Assurance
Manage processes, documents, and products in one integrated platform.
Follow a manual added link
Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
READY! stands for: REgulated Affairs DiarY
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
It has been meticulously developed to address the unique requirements of managing both structured (IDMP medicinal product information) and unstructured data (documents, forms, records) within the pharmaceutical industry.
