Starting point

• A CSV strategy has been drawn up and the applications and IT infra-structure must be coordinated with it

• As the company has expanded into the life science industry, the legal requirements must now be met or developed further

• Individual themes, such as the maintenance of validated systems or the virtualisation of infrastructure components, become increasingly important and should be able to pass future inspections

Our contribution

• Seminars or workshops to improve the understanding of CSV based on best practices (e.g. GAMP5)

• Explanation of the risk-based approach in CSV

• Highlighting an integrated compliance approach, such as GxP, ISO and SOX, in validation projects

• Highlighting procedures for infrastructure, software and virtualised system validations

Your benefit

• Familiarity with the content of computer system validation

• Understanding of the IT processes coordinated with CSV

• Improved and more effective control of different software packages and infrastructure components

• Observance of CSV in application portfolio and compliance management

• Improved justification for and coordination of IT investments