Document management and Dossiers compilation
READY! document management configuration has been developed for the needs of the pharmaceutical industry.
READY! document management and dossier compilation
READY! is a replacement for shared drives that you are using across your company.
Specific configuration of READY! replaces manual paper-based and email exchange of documents.
Using READY! is simple and users like it.
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! SOLUTIONS
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READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
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Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
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Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
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Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
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Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
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Development
Track milestones and store documents created in the development of a new medicine.
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Quality Assurance
Manage processes, documents, and products in one integrated platform.
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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.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.
