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.