A leading US pharma major had to comply with EMA (European Medical Agency) and Japan PMDA (Pharmaceutical and Medical Devices Agency) for new mandate of E2B R3 compliance for their clinical Safety Data Management: Transmission of individual case safety reports. This had to happen in short time to stay relevant and meet stringent regulatory requirement timelines.


Key Challenges

Pharma companies must report 3000+ R3 XML Case Safety data from drug safety applications, this requires significant time and effort


Adhering to regulatory compliance schedules while delivering complex testing


The Impact


reduction in testing cycle time besides stimulating the testing process


Achieved 40% automated testing of complete R3 XML and reduced manual tag-by-tag validation effort


Adhered to E2B R3 regulatory compliance in a span of 6-9 months as per each regulatory authority / agency (FDA, EMA & PMDA) timelines


The Solution

Infosys E2B R3 XML testing for Pharmacovigilance system

Leveraging design thinking driven automation solution

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Leveraging design thinking approach, a holistic end-to-end testing and verification strategy was developed to ensure domain intensive test scenarios and complex technologies are verified, adhering to stringent timelines without compromise on quality.

  • Leveraged design thinking to implement automation of data creation for 3000+ test scenarios
  • Created 3000+ reusable scenarios and complex SQL query pairs, that can be leveraged for similar future implementations with minimal updates

Developed an end-to-end testing strategy which helps in –

  • Validating R3 XML structure against the standard ICH R3 template
  • Test data automation including data validations
  • Perform Integration testing for E2B R3 XML with safety systems and Japanese language translation verification
  • Executing 350+ SQL Query pairs to validate data between safety database and R3 XML using QuerySurge tool
  • Performance testing of the solution to validate key KPIs (like E2B report generation, report transmission, etc.)
  • Coordinating end-to-end Pilot testing of R3 XMLs with agencies
  • Adherence to 21CFR Part 11 best practices for testing

Design thinking capability and automation expertise

Infosys design thinking capability gained over years of experience and its rich pool of automation experts helped developing an end-to-end testing strategy.

Optimal data testing coverage for a data lake implementation


Achieve Complete Automation with Artificial Intelligence and Machine Learning

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