• Audits of IT editors
• Project Quality plans
• Preparation of specifications
• Development follow-up, review of source codes and of technical documentation
• Defining and structuring a validation strategy: risk analysis, validation plan
• Methodology implementation: protocols, test scripts, reports and traceability matrix (DQ, IQ, OQ, PQ)
• Maintaining validated status, with specific assistance for drafting of necessary procedures
• Training on validation of IT Systems
• Audit of validation documents

Examples of validated systems:

• LIMS (Sample manager, Watson, ARES, Provantis …)
• Document Management Systems (Documentum)
• Applications dedicated to clinical, pharmacovigilance or medical domains (SAS, CLINTRACE, CLINTRIAL …)
• Statistical modules and applications (SAS routines, EXCEL, PATH/TOX …)
• Manufacturing Execution Systems (XFP …)
• Save/Restore systems (Time Navigator)
• Remote monitoring systems
• Computerized systems that monitor equipments
• ...