Version Management
P4SaMD uses workspace versions to track 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. Click the version name and pick from the dropdown of available versions to switch. The sidebar and all content views update immediately.
Creating and Managing Versions
To create a version, go to Versions in the left sidebar and click Create Version. Give it 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 ready for development.
New projects start with a default workspace version named main.
Once development is complete and all required verification activities have been carried out, release the version 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 locks a version 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.
To change anything 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: the exact timestamp, the user who made the change, and the previous and new values. Open the audit log from Settings → Audit Log. It is always scoped to the active organization, and its compliance record is complete and tamper-evident.
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