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.
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
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
Infosys E2B R3 XML testing for Pharmacovigilance system
Looking for a breakthrough solution?TALK TO OUR EXPERTS
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.
Developed an end-to-end testing strategy which helps in –
Infosys design thinking capability gained over years of experience and its rich pool of automation experts helped developing an end-to-end testing strategy.