Template: SOP Software Validation

Summary

This SOP ensures that only validated computer and software systems are used by the organization, preventing errors that could compromise the safety and performance of medical devices. It outlines the necessary validation requirements before a system can be utilized.

Process Owner	\
Key Performance Indicators	\
Regulatory References	ISO 13485:2016 Sec. 4.1.6 and 6.3 and 7.6 IEC 62304:2016 Sec. 9.8

Process Steps

1.1 Collecting Information and Preliminary Assessment

• The employee informs the QMO about the new system and provides essential information for preliminary assessment, such as a description of intended use and an initial risk evaluation.
• The QMO records the intended use and assesses whether the system is relevant to the QMS or the medical devices within the organization, using the Software Validation Form.
• If the system is deemed quality-relevant, the Software Validation Form should be completed by evaluating its criticality and associated risks.
• If the system is not quality-relevant, it should be documented in the Software List and permitted for use.

Responsible	Employee intending to use the new system QMO
Input	System information Software Validation Form Software List
Output	Preliminary software assessment

1.2 Plan Validation

• The QMO continues completing the Software Validation Form by outlining the validation plan and documenting the expected validation outcomes.

Responsible	QMO
Input	Software Validation Form
Output	Updated Software Validation Form

1.3 Perform Validation

• The validation is carried out according to the validation plan, and the validation report should be completed as part of the Software Validation Form.
• If applicable, additional validation proof (e.g., screenshots) should be collected and included in the validation report.

Responsible	Employee using the system
Input	Software Validation Form
Output	Updated Software Validation Form

1.4 Release

If validation fails:

• Document the results in the Software List and mark the system as “blocked” or “not approved for use.”

If validation is successful:

• Document and sign the validation report within the Software Validation Form.
• Approve the software and add it to the Software List.
• Notify relevant staff about the system’s approval.

Responsible	QMO
Input	Software Validation Form Software List
Output	Completed Software Validation Form Updated Software List Notification sent

1.5 Monitoring of Software

• User feedback and error reports from developers are monitored for relevant issues that could impact the organization or its medical devices.
• Updates to new versions are made, and the Software List is updated as needed. If necessary, revalidation is conducted.

Responsible	QMO in collaboration with the employee working with the system
Input	Error reports from users and developers
Output	Updated Software Validation Form New Software Validation Form record, if needed

1.6 Decommissioning of Software

• When deciding to decommission a software system, evaluate potential impacts and document the process in the Software List.

Responsible	QMO
Input	Software Validation Form Software List
Output	Updated Software List

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