{"id":35515,"date":"2015-09-06T15:34:51","date_gmt":"2015-09-06T12:34:51","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35515"},"modified":"2015-09-06T15:34:51","modified_gmt":"2015-09-06T12:34:51","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-validation-case-study-part-2","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-validation-case-study-part-2\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; Validation case study &#8211; part 2"},"content":{"rendered":"<h2 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-%D7%9E%D7%94-%D7%96%D7%94\/\">\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4<\/a> &#8211; Validation case study &#8211; part 2<\/h2>\n<p style=\"text-align: left\">\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n<h2 style=\"text-align: left\">Validation Requirements<\/h2>\n<h3 style=\"text-align: left\">Documentation for Initial Tender<\/h3>\n<p style=\"text-align: left\">Project schedule and milestones design and construction detail<\/p>\n<p style=\"text-align: left\">Project quality plan<\/p>\n<p style=\"text-align: left\">Supplier\u2019s local subsidiary\/agent<\/p>\n<p style=\"text-align: left\">Supplier\u2019s documentation that the system \/ configurable software versions are released to the market and are FDA\/EMEA compliant<\/p>\n<p style=\"text-align: left\">Compliance to the <a href=\"http:\/\/www.smartlogic.co.il\/21cfr-11\/\">21 CFR Part 11<\/a> operational requirements \u2013 the contractor should ensure covering of all the requirements described below<\/p>\n<p style=\"text-align: left\">Contractor to state the system\/product status and implementation planned for each requirement \u2013 User's approval pre-delivery<\/p>\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-dq-design-review\/\">Design Review<\/a><\/h3>\n<h4 style=\"text-align: left\"><strong><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-pid-control\/\">PID<\/a> for the system<\/strong><\/h4>\n<p style=\"text-align: left\">Electrical and pneumatic schematics<\/p>\n<p style=\"text-align: left\">:Installation data<\/p>\n<p style=\"text-align: left\">General arrangement drawings<\/p>\n<p style=\"text-align: left\">Floor loading<\/p>\n<p style=\"text-align: left\">Utility requirements<\/p>\n<p style=\"text-align: left\">Details of electronic records and approvals that may be subject to regulatory controls under <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\/\">CFR Title 21 part 11<\/a><\/p>\n<p style=\"text-align: left\">Instrumentation documentation<\/p>\n<p style=\"text-align: left\">:Main components specification<\/p>\n<p style=\"text-align: left\">Equipment<\/p>\n<p style=\"text-align: left\">Instrumentation<\/p>\n<p style=\"text-align: left\">Valves<\/p>\n<p style=\"text-align: left\">Piping<\/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%94%D7%99-%D7%9E%D7%A2%D7%A8%D7%9B%D7%AA-%D7%91%D7%A7%D7%A8%D7%94-%D7%AA%D7%A2%D7%A9%D7%99%D7%99%D7%AA%D7%99\/\">Control system<\/a><\/p>\n<p style=\"text-align: left\">Pipe welding documentation<\/p>\n<p style=\"text-align: left\">General installation book<\/p>\n<p style=\"text-align: left\">Procedures<\/p>\n<p style=\"text-align: left\">User guide<\/p>\n<p style=\"text-align: left\">Security<\/p>\n<p style=\"text-align: left\">Preventative maintenance + spare parts list<\/p>\n<p style=\"text-align: left\">Operation procedure<\/p>\n<p style=\"text-align: left\">Pressure test procedure<\/p>\n<p style=\"text-align: left\">Leak test procedure<\/p>\n<p style=\"text-align: left\">Passivation procedure<\/p>\n<p style=\"text-align: left\">Calibration<\/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-function-design-specification-fds\/\">Functional Design Specifications<\/a> for<\/p>\n<p style=\"text-align: left\">Complete manufacturing system<\/p>\n<p style=\"text-align: left\">Software &#8211;\u00a0<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> and hardware &#8211;<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\/\">HW<\/a><\/p>\n<p style=\"text-align: left\">Functional Design Specifications<\/p>\n<p style=\"text-align: left\">System Detail Design Specifications for HW and SW.<\/p>\n<p style=\"text-align: left\">SW source code, with comments,\u00a0for customized SW<\/p>\n<p style=\"text-align: left\">SW complete version history<\/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> alarm list, message list and graphical displays<\/p>\n<p style=\"text-align: left\">I\/O list<\/p>\n<p style=\"text-align: left\">:List of materials<\/p>\n<p style=\"text-align: left\">Product contact materials<\/p>\n<p style=\"text-align: left\">Potential product contact lubricants<\/p>\n<p style=\"text-align: left\">Welding procedures for product direct and indirect contact parts<\/p>\n<p style=\"text-align: left\">Pre-delivery Inspection and Factory Acceptance Test (FAT) protocols<\/p>\n<p style=\"text-align: left\">Steel certificates and gasket certificates<\/p>\n<h3 style=\"text-align: left\">Documentation Prior to FAT or Pre-Delivery Inspection &#8211;\u00a0PDI<\/h3>\n<p style=\"text-align: left\">:Progress visit report which will include<\/p>\n<p style=\"text-align: left\">Mechanical and technical development<\/p>\n<p style=\"text-align: left\">Automation and SW development<\/p>\n<p style=\"text-align: left\">:Supplier\u2019s factory test results for<\/p>\n<p style=\"text-align: left\">Unit tests &#8211; The test protocols shall be traced to low level design document and will be approved by the user prior to execution. The approval of the report shall be performed by representatives of the user's validation team, IT QA.<\/p>\n<p style=\"text-align: left\">Automation and SW development<\/p>\n<p style=\"text-align: left\">:Integration Tests \u00a0&#8211; Simulation Testing<\/p>\n<p style=\"text-align: left\">Approved PDI and FAT protocols<\/p>\n<h3 style=\"text-align: left\">Commissioning<\/h3>\n<p style=\"text-align: left\">MCCR<\/p>\n<p style=\"text-align: left\">Purpose<\/p>\n<p style=\"text-align: left\">Scope<\/p>\n<p style=\"text-align: left\">Responsibility<\/p>\n<p style=\"text-align: left\">Execution instructions<\/p>\n<p style=\"text-align: left\">System scope<\/p>\n<p style=\"text-align: left\">System description<\/p>\n<p style=\"text-align: left\">Drawing verification<\/p>\n<p style=\"text-align: left\">Equipment verification<\/p>\n<p style=\"text-align: left\">Valve verification<\/p>\n<p style=\"text-align: left\">Instrument installation and calibration<\/p>\n<p style=\"text-align: left\">Utility verification<\/p>\n<p style=\"text-align: left\">Documentations verification<\/p>\n<p style=\"text-align: left\">Piping Verification<\/p>\n<p style=\"text-align: left\">Sample Point Verification<\/p>\n<p style=\"text-align: left\">Safety, health and environment verification<\/p>\n<p style=\"text-align: left\">Slopes verification (if relevant)<\/p>\n<p style=\"text-align: left\">Electrical and communication activities<\/p>\n<p style=\"text-align: left\">Pump installation verification,\u00a0if relevant<\/p>\n<p style=\"text-align: left\">Heat exchanger installation verification, if relevant<\/p>\n<p style=\"text-align: left\">Air break verification, if relevant<\/p>\n<p style=\"text-align: left\">Dead leg verification, if relevant<\/p>\n<p style=\"text-align: left\"><strong>CE<\/strong><\/p>\n<p style=\"text-align: left\">Purpose<\/p>\n<p style=\"text-align: left\">Scope<\/p>\n<p style=\"text-align: left\">Responsibility<\/p>\n<p style=\"text-align: left\">Execution instructions<\/p>\n<p style=\"text-align: left\">System scope<\/p>\n<p style=\"text-align: left\">System description<\/p>\n<p style=\"text-align: left\">System startup<\/p>\n<p style=\"text-align: left\">Equipment verification<\/p>\n<p style=\"text-align: left\">Main equipment operation checks<\/p>\n<p style=\"text-align: left\">System <a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-function-design-specification-fds\/\">FDS <\/a>(SSO) verification<\/p>\n<p style=\"text-align: left\">System performance testing<\/p>\n<p style=\"text-align: left\">\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n<p><script>var 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 The second part of our case study  deals with the Validation Requirements of Documentation for Initial Tender,Documentation for Design Review,Documentation Prior to FAT or Pre-Delivery Inspection &#8211; PDI&amp; Commissioning<\/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":[36,85,87,99,119,129,134,165,166,167,190,195,244,277,375,428,431,437,502,504,522],"class_list":["post-35515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-21-cfr-part-11","tag-case-study","tag-ce","tag-commissioning","tag-control-system","tag-design-review","tag-design-specifications","tag-fat-en","tag-fda-en","tag-fds-en","tag-hmi-en","tag-hw","tag-mccr-en","tag-pdi","tag-sw","tag-validation-en","tag-validation-documentation","tag-validation-requirements","tag-502","tag-504","tag-522"],"_links":{"self":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35515","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=35515"}],"version-history":[{"count":0,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35515\/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=35515"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/categories?post=35515"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/tags?post=35515"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}