{"id":35537,"date":"2015-07-22T08:03:49","date_gmt":"2015-07-22T05:03:49","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35537"},"modified":"2015-07-22T08:03:49","modified_gmt":"2015-07-22T05:03:49","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-urs-and-frs-preparation-overview","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-urs-and-frs-preparation-overview\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; URS and FRS Preparation Overview"},"content":{"rendered":"<p style=\"text-align: left\">\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; URS and <a href=\"http:\/\/www.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\/\" target=\"_blank\" rel=\"noopener\">FRS <\/a>Preparation Overview<\/p>\n<p style=\"text-align: left\">\u00a0This article was written by Iian Shaya, validation,automation and control expert<\/p>\n<p style=\"text-align: left\">User Requirements Specification (URS) and Functional Requirements Specification (FRS) are the first and starting points of a<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\/\" target=\"_blank\" rel=\"noopener\"> validation<\/a> process and a<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\/\" target=\"_blank\" rel=\"noopener\"> validation documentation <\/a>file<\/p>\n<p style=\"text-align: left\">\u00a0 &#8211; The validation process must comply with regulations issued by the United States <strong>Food and Drug Administration FDA<\/strong><\/p>\n<p style=\"text-align: left\"><strong>:<\/strong>The FDA regulations that are most relevant to the validation process are<\/p>\n<p style=\"text-align: left\">Good Manufacturing Practice \u00a0&#8211; GMP.<\/p>\n<p style=\"text-align: left\">Current Good Manufacturing Practice &#8211;\u00a0cGMP<\/p>\n<p style=\"text-align: left\">Good Automated Manufacturing Practice &#8211;\u00a0<a href=\"http:\/\/www.smartlogic.co.il\/21cfr-11\/\" target=\"_blank\" rel=\"noopener\">GAMP<\/a><\/p>\n<p style=\"text-align: left\">The validation process includes design, installation and operation of a monitoring and control system for a production facility, as well as planning and execution of test procedures, to verify that a monitoring and control system meets the FDA standards<\/p>\n<p style=\"text-align: left\">Validation documentation is part of the validation process that includes written and\/or electronic records regarding the installation and operation of the monitoring and control system, and the corresponding test procedures for this system<\/p>\n<p style=\"text-align: left\">Electronic records are often required to fulfill regulations set by the FDA. These regulations regard the scope and application of <strong>Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (<a href=\"http:\/\/www.smartlogic.co.il\/21cfr-11\/\" target=\"_blank\" rel=\"noopener\">21 CFR Part 11<\/a>)<\/strong>. Electronic Records may contain any combination of text, graphics, audio, pictures, or other information represented in electronic form, which are created, modified, maintained, archived, retrieved or distributed by a computer system<\/p>\n<p style=\"text-align: left\">Electronic Signatures may contain computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be legally binding equivalent of the individual's handwritten signature<\/p>\n<p style=\"text-align: left\">Electronic records and signatures are generally used in Closed Systems, in which the system access is controlled by personnel responsible for the contents of the system electronic records<\/p>\n<p style=\"text-align: left\">The responsibility for writing and approving the URS and FRS is shared in practice by the user, who operates the production facility, and the supplier or vendor, who provides the monitoring and control system for ensuring the proper operation of the production facility. Usually, the URS is written by the user and the FRS by the supplier<\/p>\n<p style=\"text-align: left\"><strong>:Note<\/strong><\/p>\n<p style=\"text-align: left\"><strong>The final contents of the URS and FRS are tailored according to the type and size of the system under validation. Since the URS and FRS regarded herein are generic, they include requirements that may not be necessary in small or simple systems<\/strong><\/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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User Requirements Specification (URS) and Functional Requirements Specification (FRS)  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