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 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
- 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.
| Responsible |
| Employee intending to work with the new system |
| QMO |
| Input |
Output |
| Information about the system |
Preliminary Software Assessment |
| Software Validation Form |
|
| List of Softwares |
|
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.
| Input |
Output |
| Software Validation Form |
Updated Software Validation Form |
- 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 |
Output |
| Software Validation Form |
Updated Software Validation Form |
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.
| Input |
Output |
| Software Validation Form |
Completed Software Validation Form |
| Software List |
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 computerized systems is updated accordingly. If
necessary, a revalidation is carried out.
| Responsible |
| QMO in collaboration with employee working with the system |
| Input |
Output |
| Error reports by users / developers |
Updated List of Software |
| |
If required: new record of Softwares Validation Form created |
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.
| Input |
Output |
| Software Validation Form |
Updated List of Software |
| Software List |
|
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