Validation and Auditing of EDP / IT-Systems

In order to ensure quality even in complex IT structures and applications in a GxP regulated environment, we provide the qualification and validation of computer systems throughout the entire life cycle:

• Development of processes and collection of user requirements
• Design of validation concepts
• Implementation of risk analyses
• Preparation of validation plans
• Implementation of all validation activities in accordance with the respective customer-specific SOPs
• Preparation and development of test scenarios, test plans and test specifications such as IQ, OQ and PQ or UAT
• Preparation of technical documentation
• Compilation and issuing of process documentation
• Monitoring of change control processes for all documents or system changes
• Implementation of client-focused GxP/GAMP® training according to requirements
• Preparing and supervision of authority inspections
• Implementation and supervision of system audits (internal audits and IT suppliers)