Data Integrity advice, IT Quality

Our expertise, our robust and proven methodologies and the qualities of our stakeholders, allow us to support you effectively on your needs:

• Project management assistance
• Data integrity, Part 11, GxP’s, GAMP5 compliance audit of systems, organizations and suppliers by IRCA certified auditors
• Implementation of Quality system and validation procedures: Master Plan for validation, Quality procedures, process, guidance… in accordance with GxP requirements, Data integrity guidance and GAMP5 methodology.
• Assistance in setting up data integrity, GxP’s, GAMP5 compliant processes
• Assistance with the formalization of user needs (URS)
• Assistance in preparing for FDA, ANSM, Swissmedic, etc. inspections
• Periodic reviews of systems and organizations
• Periodic audit trail reviews
• Implementation of operational processes and procedures: Data integrity governance, change and configuration management, backup and restoration management, security management, incident management, periodic reviews, operational continuity, audit trail review, electronic archiving