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Computerized Systems Validation Internals

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Internal validation audits of computerized systems

We guarantee the security of the computerized systems in your company

It is of vital importance to include in the internal audits a section for the Computerized Systems

The scope of the verifications of the computerized systems audit will include the validation strategy, inventory of existing computerized systems, risk analysis to analyze the impact of the systems in GxP environments, execution of the appropriate validations and maintenance of the control status, reviewing the changes produced and actions taken.

Main activities

  • Establish audit objectives. Taking into account risk factors such as computer systems, IT infrastructure, service providers, equipment or users.
  • Execution of the audit. With the collaboration of the representatives of the computerized process, computerized systems, and quality assurance. Adopting a risk-based approach to prioritize audit activities. Collecting all results and evidence.
  • Documenting the evidence collected.
  • Corrective actions for any identified deviations or non-conformities.

Benefits to your company

The audit process is essential to review and evaluate compliance with appropriate conditions and recommend elements of improvement in this area for any company, including those working in highly regulated environments such as the manufacture of medicines or medical devices.

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