Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.
Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s Traceability.
Along with reviews, providing traceability (see IEC 62304:3006->3.32) between deliverables (see IEC 62304:3006->3.6) is one of the main requirements of IEC 62304. By providing traceability it can be proved that decisions have been thoroughly reflected and possible consequences have been considered. Therefore, it is one of the most important factors for quality and patient and user safety, which is the focus of IEC 62304.
Traceability Requirements of IEC 62304:2006
The picture below shows the traceability requirements for the deliverables of IEC 62304:2006 with dashed lines. The labels describe the type of link and the clause of the standard requiring the links (in brackets). MedPack represents most of these deliverables with Work Items, some with dedicated wiki pages.
How MedPack handles traceability
Traceability is provided by Polarions’ standard link roles. However, special link roles according to the diagram above are defined for MedPack’s work item types. The table below shows these link roles.
MedPack Link Roles
|traceability meaning||impact meaning||Description|
|traces to||leads to||Used for decision traceability.|
|covers||covered by||Used for relations between documentation and development artifacts.|
|implements||implemented by||Used for relations between concepts and concrete deliverables implementing those.|
|part of||decomposed into||Used to describe relationships of architectural elements (SW System, SW Item, SW Unit and SOUP)|
|detected by||detects||Used for relations of qm measures and resulting error descriptions.|
The provision of links is not enforced in any way, any work item can be created, modified and closed without any checks. This keeps MedPack flexible for any kind of development lifecycle model. However, checking and analysing the existences of links is a focus of the wiki pages in the Product Documentation Wiki
For more information about Polarion’s MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304. I hope you liked this article and you will visit our blog again when there is another Morris Medical Monday article.