{"id":1118,"date":"2015-01-12T12:00:35","date_gmt":"2015-01-12T20:00:35","guid":{"rendered":"https:\/\/blogs.plm.automation.siemens.com\/t5\/Polarion-Blog\/Morris-Medical-Monday-Work-Item-Type-34-System-Requirement-34\/ba-p\/380923"},"modified":"2026-03-26T05:35:06","modified_gmt":"2026-03-26T09:35:06","slug":"morris-medical-monday-work-item-type-system-requirement","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/polarion\/morris-medical-monday-work-item-type-system-requirement\/","title":{"rendered":"Morris Medical Monday: Work Item Type &#034;System Requirement&#034;"},"content":{"rendered":"<p>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&nbsp;<A href=\"http:\/\/www.polarion.com\/products\/index.php\" rel=\"nofollow noopener noreferrer\">Polarion solutions<\/A>&nbsp;and&nbsp;<A href=\"http:\/\/extensions.polarion.com\" rel=\"nofollow noopener noreferrer\">Polarion extensions<\/A>.<\/p>\n<p>Today we will continue on the subject of Polarion&#8217;s&nbsp;<A href=\"http:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304\" rel=\"nofollow noopener noreferrer\">MedPack extension<\/A>, and have a look into MedPack&#8217;s <EM>System Requirement<\/EM> type Work Item.<\/p>\n<p><!--more--><br \/>\n<H1>System Requirement<\/H1><br \/>\n<H3>Description<\/H3><br \/>\nA system requirement according to clause 5.1 of IEC 62304:2006. Any issue of this type must be linked to its child software requirement, if it the system requirement is fulfilled by software.<br \/>\n<H3 class=\"heading-1-1\"><SPAN id=\"HWorkflowSteps\">Workflow Steps<\/SPAN><\/H3><br \/>\nThe System Requirement Work Item uses the standard <SPAN class=\"wikilink\">Evaluation Workflow<\/SPAN>.<\/p>\n<p><A href=\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2014\/09\/EvaluationWorkflow_Overview.png\" rel=\"nofollow noopener noreferrer\"><IMG class=\"alignnone size-full wp-image-6489\" src=\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2014\/09\/EvaluationWorkflow_Overview.png\" alt=\"EvaluationWorkflow_Overview\" width=\"222\" height=\"50\" \/><\/A><br \/>\n<H3 class=\"heading-1-1\"><SPAN id=\"HTraceability26amp3BImpact\">Traceability &amp; Impact<\/SPAN><\/H3><br \/>\nA System Requirement Work Item has an impact on a <SPAN class=\"wikilink\">Software Requirement<\/SPAN>.<br \/>\nFor more information on traceability and impacts, see the <SPAN class=\"wikilink\">Traceability wiki page<\/SPAN>.<br \/>\n<H3 class=\"heading-1-1\"><SPAN id=\"HAttributes\">Attributes<\/SPAN><\/H3><br \/>\n<H4 class=\"heading-1-1-1\"><SPAN id=\"HWorkItemAttributes\">Work Item Attributes<\/SPAN><\/H4><br \/>\nThe following custom fields must be filled out before evaluation can be requested:<br \/>\n<TABLE class=\"polarion-wiki-table\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><br \/>\n<THEAD><br \/>\n<TR><br \/>\n<TH class=\"polarion-wiki-table-th\">Attribute Name<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Type<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Description<\/TH><br \/>\n<\/TR><br \/>\n<\/THEAD><br \/>\n<\/TABLE><br \/>\n<H4 class=\"heading-1-1-1\"><SPAN id=\"HEvaluationAttributes\">Evaluation Attributes<\/SPAN><\/H4><br \/>\nThe following custom fields must be filled out before evaluation can be finshed and the work item can be closed:<br \/>\n<TABLE class=\"polarion-wiki-table\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><br \/>\n<THEAD><br \/>\n<TR><br \/>\n<TH class=\"polarion-wiki-table-th\">Attribute Name<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Type<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Description<\/TH><br \/>\n<\/TR><br \/>\n<\/THEAD><br \/>\n<TBODY><br \/>\n<TR class=\"table-odd\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Reviewer<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Text<\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Person(s) to perform, performing or have performed a review.<\/TD><br \/>\n<\/TR><br \/>\n<TR class=\"table-even\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Review summary<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Text<\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Short summary of the review. Attachments should be used for additional information.<\/TD><br \/>\n<\/TR><br \/>\n<TR class=\"table-odd\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Last review date<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Date<\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.<\/TD><br \/>\n<\/TR><br \/>\n<\/TBODY><br \/>\n<\/TABLE><br \/>\n<H4 class=\"heading-1-1-1\"><SPAN id=\"HEvaluationChecklist\">Evaluation Checklist<\/SPAN><\/H4><br \/>\nThe following checklist must be filled out before evaluation can be finshed and the work item can be closed:<br \/>\n<TABLE class=\"polarion-wiki-table\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><br \/>\n<THEAD><br \/>\n<TR><br \/>\n<TH class=\"polarion-wiki-table-th\">Checklist entry<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Description<\/TH><br \/>\n<\/TR><br \/>\n<\/THEAD><br \/>\n<\/TABLE><br \/>\n<H4 class=\"heading-1-1-1\"><SPAN id=\"HPossibleResolutions\">Possible Resolutions<\/SPAN><\/H4><br \/>\nThe following table shows the possible resolution values when the work item is closed:<br \/>\n<TABLE class=\"polarion-wiki-table\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><br \/>\n<THEAD><br \/>\n<TR><br \/>\n<TH class=\"polarion-wiki-table-th\">Resolution Name<\/TH><br \/>\n<TH class=\"polarion-wiki-table-th\">Description<\/TH><br \/>\n<\/TR><br \/>\n<\/THEAD><br \/>\n<TBODY><br \/>\n<TR class=\"table-odd\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Approved<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">The system requirement has been approved and needs to be implemented.<\/TD><br \/>\n<\/TR><br \/>\n<TR class=\"table-even\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Not Approved<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">The system requirement has not been approved. No further action is needed.<\/TD><br \/>\n<\/TR><br \/>\n<TR class=\"table-odd\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Obsolete<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">The system requirement has become obsolete and is no longer needed.<\/TD><br \/>\n<\/TR><br \/>\n<TR class=\"table-even\"><br \/>\n<TD class=\"polarion-wiki-table-td\"><STRONG class=\"strong\">Discarded<\/STRONG><\/TD><br \/>\n<TD class=\"polarion-wiki-table-td\">The work item entry has been discarded. No further attention is needed.<\/TD><br \/>\n<\/TR><br \/>\n<\/TBODY><br \/>\n<\/TABLE><br \/>\nFor more information about Polarion&#8217;s MedPack visit our Extension Portal using following link:<\/p>\n<p><A href=\"http:\/\/extensions.polarion.com\/extensions\/31-polarion-alm-medpack-iec-62304\" rel=\"nofollow noopener noreferrer\">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&nbsp;<B>Morris Medical Monday&nbsp;<\/B>article.<\/p>\n<p><HR \/><br \/>\n<P style=\"text-align: center;\"><A href=\"http:\/\/www.polarion.com\/products\/medical\/index.php?utm_source=morrisMedical&amp;utm_medium=web&amp;utm_campaign=blog\" rel=\"nofollow noopener noreferrer\"><IMG class=\"alignnone size-full wp-image-5457\" src=\"http:\/\/community.plm.automation.siemens.com\/legacyfs\/online\/siemensplm_blogs\/2014\/04\/medical-device-solutions-by-polarion.jpg\" alt=\"Medical device solutions by Polarion\" width=\"600\" height=\"350\" \/><\/A><\/P><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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&nbsp;Polario&#8230;<\/p>\n","protected":false},"author":63333,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spanish_translation":"","french_translation":"","german_translation":"","italian_translation":"","polish_translation":"","japanese_translation":"","chinese_translation":"","footnotes":""},"categories":[1],"tags":[],"industry":[],"product":[],"coauthors":[],"class_list":["post-1118","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/1118","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/users\/63333"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/comments?post=1118"}],"version-history":[{"count":1,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/1118\/revisions"}],"predecessor-version":[{"id":1119,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/posts\/1118\/revisions\/1119"}],"wp:attachment":[{"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/media?parent=1118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/categories?post=1118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/tags?post=1118"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/industry?post=1118"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/product?post=1118"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/polarion\/wp-json\/wp\/v2\/coauthors?post=1118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}