Case Safety Reports - ICSR
A fitting ICSR (Individual Case Safety Report) processing with ongoing management of all ICSR tasks significantly contributes to the compliance of your organisation.
CSO Pharma provides a ICSR processing compliant with regulatory requirements.
- according to the GVP module
- Management of documents to ensure compliance
- Integrated Quality- and Pharmacovigilance standards
Documentation and Management
- Documentation according to current standards
- Check lists
- QM-based implementation
- Change control
- Review- and Release management
- Performance indicators and compliance
ICSR-Online - Access & Features
- 24x7 controlled, password protected access
- Access control on document level if needed
- User management
- Audit trail
- Version control
- Automated reminder function
- Archiving and back-up
- Designed for global use
- Enlargement to multiple languages can be implemented at any time
- Anlarge to Product Quality Complaint processing
We support you to strenghten your ICSR processing system.
For further information, please feel to contact us. We are looking forward to your enquiry.