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.

Structure

  • 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.

Audits

Pharmaceutical companies are regulatory obliged to ensure internal and compliance of contracted partner through audits >>

PV training

CSO Pharma actively supports you with trainings on Pharmacovigilance. To accomplish more with profound knowledge >>

Processes - SOPs

CSO Pharma implementiert Prozesse & zugehörige Schnittstellen und gibt Antworten zur Aktualität, Vollständigkeit und Validität von SOPs >>