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 Owner | <enter role of process owner> |
| Key Performance Indicators | <enter KPIs to be tracked for the Management Review> |
| 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
- 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 Software Validation Form.
- If quality-relevant: continue to fill out the Software Validation Form (assessing criticality and risks).
- If not quality-relevant: document the system in the Software List and release the software system for use.
| Responsible | Employee intending to work with the new system QMO |
|---|---|
| Input | Information about the system Software Validation Form List of Software |
| Output | Preliminary Software Assessment |
1.2 Plan Validation
- QMO continues to fill out the Software Validation Form by planning the validation and documenting the requirements for expected validation results.
| Responsible | QMO |
|---|---|
| Input | Software Validation Form |
| Output | Updated Software Validation Form |
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.
| Responsible | Employee working with the system |
|---|---|
| Input | Software Validation Form |
| Output | Updated Software Validation Form |
1.4 Release
If validation was not successful:
- Document the validation results in the List of Software 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 Software Validation Form.
- Release the software by adding it to the List of Software.
- Inform relevant staff about the approval of the system.
| Responsible | QMO |
|---|---|
| Input | Software Validation Form List of Software |
| Output | Completed Software Validation Form Updated List of Software Notification Sent |
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 Software is updated accordingly. If necessary, a revalidation is carried out.
| Responsible | QMO in collaboration with employee working with the system |
|---|---|
| Input | Error reports by users / developers |
| Output | Updated Software Validation Form If required: new record of Softwares Validation Form created |
1.6 Decommissioning of Software
- In case it is decided to decommission a software, evaluate possible effects and document the actions in the List of Software.
| Responsible | QMO |
|---|---|
| Input | Software Validation Form List of Software |
| Output | Updated List of Software |
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