Computerized system validation (CSV; German translation: Validierung computergestützter Systeme) in the pharmaceutical industry serves to confirm and document that a computerized system (e.g. database management system, automated quality control system) performs its tasks in accordance with predefined specifications and standards. This process is intended to ensure that the system works in a reliable, consistent and reproducible manner.

Validation comprises several important steps:

• Planning: Definition of the scope and objectives of the validation, including the definition of success criteria.
• Risk assessment (German translation: Risikobewertung): Analysis of the potential risks associated with the system and ways to minimize them.
• Specification: Definition of the exact requirements that the system must fulfill.
• Hardware and software qualification: Ensuring that the hardware and software meet the specified requirements.
• Testing: Carrying out tests to confirm that the system works according to specifications. This can include functional tests, performance tests and other types of tests.
• Documentation and reports: Documentation of validation results and procedures to ensure that the system continually meets the specified standards.
  Support and maintenance: Regular monitoring and maintenance (German: Wartung) of the system in order to maintain its validated status.

Computerized system validation is particularly important in the pharmaceutical industry as it helps to ensure accuracy, reliability and consistency of processes and data, which is critical to the safety and quality of drugs.

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