Software Validation

eClinica has gained a strong expertise in IT Software Validation that allows us to support pharmaceutical, biotechnology, medical devices and related industries to comply with FDA and European regulatory requirements - including 21 CFR Part 11.
eClinica experienced consultants can help you at the different stages of your validation process of all types of Softwares (ERP, LIMS, GED….):

  • Support in the identification of user requirements and for URS (User Requirements Specifications) redaction
  • Support in the design phase of the systems
  • Support in the redaction of functional and technical specifications
  • Risk management (based on applicable regulatory requirements)
  • Deviation management
  • Validation Strategy : protocol design, IQ/OQ/PQ tests
  • Reporting and Traceability Matrix of tests/specifications/risks
  • Draft of IT and Business processes
  • Changes management and follow up
  • Users training