Welcome back to the first Morris Medical Monday article of the new year. I hope you had a great holiday season. For anyone who is new to our blog, this 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 SOUP Work Item.
A description of a software component of unknown provenance (SOUP) used in the project, according to clause 3.29 of IEC 62304:2006. Any issue of this type must be linked to the software item that is implemented by the component.
The SOUP Work Item uses the standard .
Traceability & Impact
A SOUP Work Item must be traceable to a Work Item and a Work Item and has an impact on an Work Item and a Work Item.
For more information on traceability and impacts, see the .
A SOUP work item has special hyperlink roles to fulfill the requirements of IEC 62304. The following tables lists thos roles.
|Published anomaly list||URL of an anomaly list for the used SOUP component|
|SOUP manufacturer||URL of the manufacturer’s homepage.|
|SOUP URL||URL of additional information about the SOUP component.|
Work Item Attributes
The following custom fields must be filled out before evaluation can be requested:
|SOUP title||Text||(as required by->8.1.2a).|
|SOUP manufacturer||Text||(as required by->8.1.2b).|
|SOUP designator||Text||(as required by->8.1.3c).|
|System hardware and software requirement [B,C]||Text||Example: Processor type, storage type, system-software type,…(as required by->5.3.3).|
|Functional and performance requirement [B,C]||Text||(as required by->5.3.4).|
The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:
|Reviewer||Text||Person(s) to perform, performing or have performed a review.|
|Review summary||Text||Short summary of the review. Attachments should be used for additional information.|
|Last review date||Date||Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.|
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
The following table shows the possible resolution values when the work item is closed:
|Ready For Use||The SOUP element has been evaluated and can be used in the product.|
|Obsolete||The SOUP element has become obsolete and is no longer needed.|
|Discarded||The work item entry has been discarded. No further attention is needed.|
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