{"id":35514,"date":"2015-09-09T07:41:36","date_gmt":"2015-09-09T04:41:36","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35514"},"modified":"2015-09-09T07:41:36","modified_gmt":"2015-09-09T04:41:36","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-3-validation-case-study-part","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-3-validation-case-study-part\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; 3 Validation case study &#8211; part"},"content":{"rendered":"<h2 style=\"text-align: left\">\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; 3 Validation case study &#8211; part<\/h2>\n<p style=\"text-align: left\">&nbsp;This article was written by Iian Shaya, validation,automation and control expert<\/p>\n<figure id=\"attachment_2181\" aria-describedby=\"caption-attachment-2181\" style=\"width: 283px\" class=\"wp-caption alignleft\"><a class=\"single_photoswipe\" data-size=\"1152x2048\" href=\"http:\/\/smartlogic.co.il\/wp-content\/uploads\/2015\/05\/\u05e9\u05e2\u05d9\u05d4-\u05e2\u05d5\u05de\u05d31.jpg\"><img fetchpriority=\"high\" decoding=\"async\" class=\" wp-image-2181\" src=\"http:\/\/smartlogic.co.il\/wp-content\/uploads\/2015\/05\/\u05e9\u05e2\u05d9\u05d4-\u05e2\u05d5\u05de\u05d31.jpg\" alt=\"\u05d0\u05d9\u05dc\u05df \u05e9\u05e2\u05d9\u05d4 Ilan Shaya\" width=\"283\" height=\"503\"><\/a><figcaption id=\"caption-attachment-2181\" class=\"wp-caption-text\">Ilan Shaya CEO , control and automation specialist and designer<\/figcaption><\/figure>\n<h3 style=\"text-align: left\">Documentation for <a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-installation-qualification-iq-protocol\/\">IQ<\/a> and <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; to be checked at PDI\/FAT<\/h3>\n<p style=\"text-align: left\">Welding reports<\/p>\n<p style=\"text-align: left\">Surfaces finishing test reports<\/p>\n<p style=\"text-align: left\">PDI and FAT results<\/p>\n<p style=\"text-align: left\">As-built drawings,&nbsp;3 sets in nominated project language, plus 1 set in English<\/p>\n<p style=\"text-align: left\">As-installed versions of all documentation submitted for <a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-dq-design-review\/\">design review<\/a><\/p>\n<p style=\"text-align: left\">Back-up software on diskette\/CD-ROM, as appropriate, ready for re-installment<\/p>\n<p style=\"text-align: left\">Machine configuration\/start up, set-up and commissioning data,&nbsp;including tabulation of all change parts and identifications<\/p>\n<p style=\"text-align: left\">Full machine parts list<\/p>\n<p style=\"text-align: left\">Complete documentation (protocols and method statements) required for equipment <a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-dq-design-review\/\">DQ<\/a>, calibration, <a 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\/\">IQ<\/a> and <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-2\/\">OQ<\/a> specified for manual and automatic operations<\/p>\n<p style=\"text-align: left\">Calibration certificates for all required instruments to NIST<\/p>\n<p style=\"text-align: left\">Specification for all parts manufactured by sub-contractors<\/p>\n<p style=\"text-align: left\">Full identification of all parts according to the P&amp;ID, including valves, regulators, instruments, pipes, media and flow direction arrows<\/p>\n<p style=\"text-align: left\">Tags for electrical and pneumatic wiring<\/p>\n<p style=\"text-align: left\">Documentation to ensure qualification in compliance with FDA and EMEA, as outlined above<\/p>\n<h3 style=\"text-align: left\">DQ Protocols&nbsp;Including PC<a 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><\/h3>\n<p style=\"text-align: left\">Approval<\/p>\n<p style=\"text-align: left\">Statement of purpose<\/p>\n<p style=\"text-align: left\">System description<\/p>\n<p style=\"text-align: left\">Traceability matrix<\/p>\n<h3 style=\"text-align: left\">IQ Protocols Including PC\/<a 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-topics-part-1\/\">PLC<\/a><\/h3>\n<p style=\"text-align: left\">Approval<\/p>\n<p style=\"text-align: left\">Statement of purpose<\/p>\n<p style=\"text-align: left\">System description<\/p>\n<p style=\"text-align: left\">Specifications<\/p>\n<p style=\"text-align: left\">Materials in product contact<\/p>\n<p style=\"text-align: left\">Engineering drawings<\/p>\n<p style=\"text-align: left\">Subsystem inspection<\/p>\n<p style=\"text-align: left\">Components<\/p>\n<p style=\"text-align: left\">Piping<\/p>\n<p style=\"text-align: left\">Valves<\/p>\n<p style=\"text-align: left\">Instrumentation and calibrations<\/p>\n<p style=\"text-align: left\">PC\/<a 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\/\">PLC<\/a> requirement definition<\/p>\n<p style=\"text-align: left\">Software development documentation<\/p>\n<p style=\"text-align: left\">Manual \/ technical literature<\/p>\n<p style=\"text-align: left\">Test equipment data sheet<\/p>\n<p style=\"text-align: left\">Component data sheets<\/p>\n<p style=\"text-align: left\">Utility requirements<\/p>\n<p style=\"text-align: left\">Exceptional conditions,&nbsp;if required<\/p>\n<p style=\"text-align: left\">Summary<\/p>\n<h3 style=\"text-align: left\">OQ Protocols Including PC\/<a 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-create-the-generic-plc-model\/\">PLC<\/a><\/h3>\n<p style=\"text-align: left\">Statement of purpose<\/p>\n<p style=\"text-align: left\">System description<\/p>\n<p style=\"text-align: left\">Manual and automatic control over all modules through <a 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%90%D7%99%D7%9A-%D7%9E%D7%9B%D7%99%D7%A0%D7%99%D7%9D-hmi-%D7%9C%D7%91%D7%93%D7%99%D7%A7%D7%AA-%D7%9C%D7%95%D7%97\/\">HMI<\/a><\/p>\n<p style=\"text-align: left\">PC\/<a href=\"http:\/\/smartlogic.co.il\/%d7%95%d7%9c%d7%93%d7%99%d7%a6%d7%99%d7%94-validation-case-study-part-1\/\">PLC<\/a> validation protocols<\/p>\n<p style=\"text-align: left\">Step-by-step checking of schedule of system operation &#8211;&nbsp;SSO<\/p>\n<p style=\"text-align: left\">Alarm and message reaction<\/p>\n<p style=\"text-align: left\"><a 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> synoptic screen vs. P&amp;ID<\/p>\n<p style=\"text-align: left\">System operation tests<\/p>\n<p style=\"text-align: left\">Operation tests for HMI to ensure compliance with<a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-%D7%9E%D7%A6%D7%92%D7%AA-%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%AA%D7%95%D7%9A-%D7%A9%D7%99%D7%9E%D7%95%D7%A9\/\"> 21 CFR part 11<\/a><\/p>\n<p style=\"text-align: left\">Application software certification<\/p>\n<p style=\"text-align: left\">HW documentation<\/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-testing-and-hwsw-type-and-maturity\/\">SW<\/a> code<\/p>\n<p style=\"text-align: left\">SW components data sheets<\/p>\n<p style=\"text-align: left\">HW components data sheets<\/p>\n<p style=\"text-align: left\"><a 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> configuration<\/p>\n<p style=\"text-align: left\">Graph printout<\/p>\n<p style=\"text-align: left\">Synoptic screen list and printout<\/p>\n<p style=\"text-align: left\">Operation screen list and printout<\/p>\n<p style=\"text-align: left\">Parameters list screen<\/p>\n<p style=\"text-align: left\">Messages and alarms list, and printout<\/p>\n<p style=\"text-align: left\">HW inspections<\/p>\n<p style=\"text-align: left\">SW inspections and application<\/p>\n<p style=\"text-align: left\">Approved schematic description<\/p>\n<p style=\"text-align: left\">Ladder diagram validation<\/p>\n<p style=\"text-align: left\">PLC capabilities<\/p>\n<p style=\"text-align: left\">PLC accuracy<\/p>\n<p style=\"text-align: left\">SW development documentation<\/p>\n<p style=\"text-align: left\">List of control devices<\/p>\n<p style=\"text-align: left\">Exceptional conditions<\/p>\n<p style=\"text-align: left\">Reports &#8211; verification of authorization inspection<\/p>\n<h3 style=\"text-align: left\"><a href=\"http:\/\/www.smartlogic.co.il\/%D7%AA%D7%99%D7%A7%D7%99-%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-%D7%9E%D7%95%D7%A9%D7%92%D7%99%D7%9D-%D7%9B%D7%9C%D7%9C%D7%99%D7%99%D7%9D\/\">PQ<\/a> Protocols Including PC\/PLC<\/h3>\n<p style=\"text-align: left\">Statement of purpose<\/p>\n<p style=\"text-align: left\">Analysis procedures<\/p>\n<p style=\"text-align: left\">Staff instruction<\/p>\n<p style=\"text-align: left\">Plan for sampling<\/p>\n<p style=\"text-align: left\">Criteria for acceptance<\/p>\n<p style=\"text-align: left\">&nbsp;This article was written by Iian Shaya, validation,automation and control expert<\/p>\n<p><script>var 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third part of our Validation case study includes Documentation for IQ and OQ &#8211; to be checked at PDI\/FAT, DQ Protocols Including PC\/PLC, IQ Protocols Including PC\/PLC, OQ Protocols Including PC\/PLC, PQ Protocols Including PC\/PLC<\/p>\n","protected":false},"author":2,"featured_media":35520,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[36,85,129,143,154,165,166,190,195,228,257,270,277,285,290,292,366,375,428],"class_list":["post-35514","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-21-cfr-part-11","tag-case-study","tag-design-review","tag-dq-en","tag-emea","tag-fat-en","tag-fda-en","tag-hmi-en","tag-hw","tag-iq","tag-nist-en","tag-oq-en","tag-pdi","tag-plc","tag-plcs-en","tag-pq-en","tag-sso","tag-sw","tag-validation-en"],"_links":{"self":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35514","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=35514"}],"version-history":[{"count":0,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35514\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media?parent=35514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/categories?post=35514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/tags?post=35514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}