Validation of GxP Systems

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

• Validation plan
• Specifications in GAMP format: functional requirements (URS), design
• Risk Analysis
• Requirements traceability matrix
• Qualifications (QC / IQ / QO / QP)
• Data migration
• Infrastructure qualification according to ITIL good practices
• Operational and maintenance procedures