Version Management
P4SaMD uses workspace versions to track the evolution of your medical device software through its development lifecycle. Each version is a named, timestamped snapshot of all project artifacts — requirements, risks, software items, and test evidence — at a specific point in time, aligned with IEC 62304 configuration management requirements.
The active version is always shown in the project header. You can switch to a different version by clicking the version name and choosing from the dropdown list of all available versions; the sidebar and all content views update immediately to reflect your selection.
Creating and Managing Versions
To create a new version, go to Versions in the left sidebar and click Create Version. You provide a name (for example v1.0.0 or 2.3-beta) and an optional description. The new version starts as a Draft, pre-populated with the current state of all project artifacts, and is immediately available for active development.
When development on a version is complete and all required verification activities have been carried out, you release it via Versions → [version name] → In Review → Frozen → Release. The Frozen status is approved and ready for release; no edits allowed unless re-open the In Review status. Releasing a version locks it permanently — all artifacts become read-only, the release date and releasing user are recorded, and a release summary is generated. Released versions cannot be modified or deleted; they are permanent compliance records.
If you need to make changes after release, create a new version and work from there.
Audit Trail
Every change to an artifact within a version is recorded in the audit log with the exact timestamp, the user who made the change, and the previous and new values. The audit log is accessible from Settings → Audit Log and is always scoped to the active organization, ensuring that the compliance record is complete and tamper-evident.
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