Argus Safety Cloud Implementation and Validation on Oracle Cloud for KAEL-GemVax

Introduction

A few products developed by GemVax were ready for marketing, but the organization did not have any safety system in place. They needed validated safety system to be implemented, in time, for marketing.

Key Challenges:

  • Limited understanding of safety system implementation
  • Implementing a fully validated safety system in time to market the drugs
  • End-user training to work on the newly implemented system

What was achieved for the client:

  • Fully validated system as per GAMP 5 guidelines
  • Reduction in human effort for case processing
  • Regulatory compliant system with the ability to perform end-to-end case processing

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