{"id":1106,"date":"2014-12-08T18:30:01","date_gmt":"2014-12-09T02:30:01","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-Type-34-Software-System-34\/ba-p\/380918"},"modified":"2026-03-26T05:35:05","modified_gmt":"2026-03-26T09:35:05","slug":"morris-medical-monday-work-item-type-software-system","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-type-software-system\/","title":{"rendered":"Morris Medical Monday: Work Item Type "Software System""},"content":{"rendered":"

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<\/A> and Polarion extensions<\/A>.<\/p>\n

Today we will continue on the subject of Polarion’s MedPack extension<\/A>, and have a look into MedPack’s “Software System” Work Item type.<\/p>\n


\n

Software System<\/H1>
\n

Description<\/H3>
\nA description of a software system according to clauses 3.27 and 3.25 of IEC 62304:2006. Any issue of this type must be linked to its child software item(s). See the note in clause 3.25 for further information about software decomposition.
\n

Workflow Steps<\/SPAN><\/H3>
\nThe Software System Work Item uses the standard Verification Workflow<\/SPAN>.<\/p>\n

\"VerificationWorkflow_Overview\"<\/A>
\n

Traceability & Impact<\/SPAN><\/H3>
\nA Software System Work Item must be traceable to a Architectural Design<\/SPAN> Work Item and has an impact on a Software Item<\/SPAN> Work Item, a Integration Test<\/SPAN> Work Item and a Hazardous Situation<\/SPAN> Work Item.
\nFor more information on traceability and impacts, see the Traceability wiki page<\/SPAN>.
\n

Attributes<\/SPAN><\/H3>
\n

Work Item Attributes<\/SPAN><\/H4>
\nThe following custom fields must be filled out before verification can be requested:
\n
\n
\n
\n
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Software Safety Class<\/STRONG><\/TD>
\n		Enum (A,B,C)<\/TD>
\n		A Software System have to classified in one of the following Software Safety Classes:
\n– Software Safety Class A (No injury or damage to health is possible)
\n– Software Safety Class B (Non-serious injury is possible)
\n– Software Safety Class C (Death or serious injury is possible)
\n(as required by IEC 62304:2006<\/SPAN>->4.3).<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n

Verification Attributes<\/SPAN><\/H4>
\nThe following custom fields must be filled out before verification can be finshed and the work item can be closed:
\n
\n
\n
\n
\n
\n
\n
\n
Attribute Name<\/TH>
\n		Type<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Reviewer<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Person(s) to perform, performing or have performed a review.<\/TD>
\n<\/TR>
\n
Review summary<\/STRONG><\/TD>
\n		Text<\/TD>
\n		Short summary of the review. Attachments should be used for additional information.<\/TD>
\n<\/TR>
\n
Last review date<\/STRONG><\/TD>
\n		Date<\/TD>
\n		Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\n

Verification Checklist<\/SPAN><\/H4>
\nThe following checklist must be filled out before verification can be finshed and the work item can be closed:
\n
\n
\n
\n
Checklist entry<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n<\/TABLE>
\n

Possible Resolutions<\/SPAN><\/H4>
\nThe following table shows the possible resolution values when the work item is closed:
\n
\n
\n
\n
\n
\n
\n
\n
Resolution Name<\/TH>
\n		Description<\/TH>
\n<\/TR>
\n<\/THEAD>
\n
Implemented<\/STRONG><\/TD>
\n		The software system has been implemented.<\/TD>
\n<\/TR>
\n
Obsolete<\/STRONG><\/TD>
\n		The software system has become obsolete and is no longer needed.<\/TD>
\n<\/TR>
\n
Discarded<\/STRONG><\/TD>
\n		The work item entry has been discarded. No further attention is needed.<\/TD>
\n<\/TR>
\n<\/TBODY>
\n<\/TABLE>
\nFor more information about Polarion’s MedPack visit our Extension Portal using following link:<\/p>\n

http:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304<\/A>I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday <\/B>article<\/p>\n


\n

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