Validation of clinical systems

More and more computerized systems are used in clinical trials. Software Validation is as much applicable to GCP systems as to GMP systems. Core to clinical trials is the data, as the result of a clinical trial is not a physical product but rather data relating to safety of an investigational medical product.

Differences between manufacturing systems and clinical trial systems make that special care and thoughts are required when validating clinical trial systems. The lifecycle of a system used in a clinical trial is a lot shorter and from a project character. Systems are configured or customized trial specifically, leveraging the validation activities between clinical trials is crucial.

As a clinical trial is conducted in different sites and countries, the effort to maintain and manage the quality and data integrity of the data is considerably bigger and more complex. As changes during the clinical trial can occur on both the system level as on the study level, strong change management and configuration management processes need to be in place to maintain the validated state of the systems. The QbD software validation experts are experienced in validating clinical computer systems and pharmaceutical software, including:

  • Electronic Data Capture Systems (EDC)
  • Clinical Database Management Systems
  • Interactive Voice Response / Interactive web response systems (IVRS/IWRS)
  • Randomization Systems
  • Statistical Systems

More information? Feel free to contact us!

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