SOP Software Validation

Summary

This SOP ensures that the organization only works with validated computer/software systems to avoid erroneous systems affecting the safety and performance of its medical devices. The process outlines requirements for validation before use.

Process Steps

1.1 Collecting Information and Preliminary Assessment

• Employee notifies QMO of the new system and provides the minimum information required for preliminary assessment, such as intended use description and preliminary risk estimation.
• QMO documents the intended use and determines whether the system is relevant for the QMS or the organization’s medical devices as part of the computerized system validation form.
• If quality-relevant: continue to fill out the computerized system validation form (assessing criticality and risks).
• If not quality-relevant: document the system in the list of computerized systems and release the software system for use.

1.2 Plan Validation

• QMO continues to fill out the computerized system validation form by planning the validation and documenting the requirements for expected validation results.

1.3 Perform Validation

• Perform the validation based on the validation plan and fill out the validation report as part of the software validation form.
• Where appropriate, save additional proof of validation (e.g. screenshots) and add them to the validation report.

1.4 Release

If validation was not successful:

• Document the validation results in the list of computerized systems and classify the system as “blocked” / “not released for use”.

If validation was successful:

• Document the validation results and sign the validation report as part of the computerized system validation form.
• Release the computerized system by adding it to the list of computerized systems.
• Inform relevant staff about the approval of the system.

1.5 Monitoring of Softwares

• User feedback and error reports by developers are monitored for relevant occurrences that may affect the organization or its medical devices.
• New version updates are implemented and the list of computerized systems is updated accordingly. If necessary, a revalidation is carried out.

1.6 Decommissioning of Software

• In case it is decided to decommission a computerized system, evaluate possible effects and document the actions in the List of Software.

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