Systems GxP, data integrity, quality, validation
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
As part of our development, we are strengthening our teams.