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