{"id":2394,"date":"2017-07-31T11:03:53","date_gmt":"2017-07-31T09:03:53","guid":{"rendered":"http:\/\/www.kraemer-elektronik.com\/system-validation\/"},"modified":"2017-08-22T17:10:16","modified_gmt":"2017-08-22T15:10:16","slug":"system-validation","status":"publish","type":"page","link":"https:\/\/www.kraemer-elektronik.com\/en\/service\/system-validation\/","title":{"rendered":"System validation"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row_content_no_spaces&#8221; content_placement=&#8221;top&#8221;][vc_column]<div class='wpb_content_element empty_space'>\n\t<div class='hidden-xs ' style='padding-top: 600px;'><\/div>\n\t<div class='visible-xs ' style='padding-top: 200px;'><\/div>\n<\/div><div class='gambit_background_row' style='background-image: url(https:\/\/www.kraemer-elektronik.com\/app\/uploads\/2017\/03\/system-validation-kraemer-elektronik.jpg);background-size: cover;background-position: center;'><\/div>[\/vc_column][\/vc_row][vc_row][vc_column]<div class='wpb_content_element empty_space'>\n\t<div class='hidden-xs padding_top_big' style=''><\/div>\n\t<div class='visible-xs padding_top_big' style=''><\/div>\n<\/div>[vc_column_text]<\/p>\n<h1>System validation by Kraemer Elektronik<\/h1>\n<p>Are you prepared for Total Quality Management (TQM) and audits?[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li>In many companies, equipment qualification as part of quality management or validation is an indispensable prerequisite for selecting suppliers<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Final test reports and adjustment and calibration reports are included with all testing units<\/li>\n<li>We are happy to provide you with IQ\/OQ documentation to assist in your own in-house IQ\/OQ processes<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row ke_row_background_color=&#8221;bg_grey_very_light&#8221;][vc_column]<div class='wpb_content_element empty_space'>\n\t<div class='hidden-xs padding_top_medium_big' style=''><\/div>\n\t<div class='visible-xs padding_top_medium_big' style=''><\/div>\n<\/div>[vc_column_text]<\/p>\n<h2>IQ \u2013 Installation Qualification<\/h2>\n<p>[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]The Installation Qualification IQ is documented proof that testing units have been supplied and installed in conformity with the requirements in the design qualification and legal safety regulations. The Installation Qualification documentation consists of an IQ inspection plan and IQ report.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]<\/p>\n<h3 class=\"text-uppercase\"><span class=\"text-uppercase\">Scope<\/span> of the Installation Qualification&nbsp;IQ:<\/h3>\n<ul>\n<li>Inventory of delivered components and inspection to ensure conformity with the order form<\/li>\n<li>\u2028Inspection of manufacturer&#8217;s documentation to ensure conformity\u2028 (nameplate, delivery note)<\/li>\n<li>Inspection of assembly and correct &shy;installation based on system diagrams (if required)<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner]<div class='wpb_content_element empty_space'>\n\t<div class='hidden-xs padding_top_very_small' style=''><\/div>\n\t<div class='visible-xs padding_top_very_small' style=''><\/div>\n<\/div>[\/vc_column][\/vc_row][vc_row][vc_column]<div class='wpb_content_element empty_space'>\n\t<div class='hidden-xs padding_top_medium_big' style=''><\/div>\n\t<div class='visible-xs padding_top_medium_big' style=''><\/div>\n<\/div>[vc_column_text]<\/p>\n<h2>OQ \u2013 Operational Qualification<\/h2>\n<p>[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]The Operational Qualification OQ is an inspection process that assesses the correct function of the testing device. During the Operational Qualification OQ, all the points in the inspection plan &shy;are checked and documented in writing. &shy;Under certain circumstances, OQ inspections may be performed with customer products only (as is usually&shy; only the case with the Performance Qualification PQ).<\/p>\n<p>Passing the Operational Qualification OQ is a precondition for the technical acceptance of a testing device. The Operational&shy; Qualification can only be performed if the Installation&shy; Qualification IQ has been passed. The Operational Qualification documentation consists of an OQ inspection &shy;plan and OQ report.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text]The Operational Qualification OQ includes the &shy;<br \/>\nidentifi&shy;cation and checking of the following&shy; alarm, control and switching functions, which have an influence on quality:<\/p>\n<ul>\n<li>Testing unit initialization<\/li>\n<li>Weight adjustment and calibration<\/li>\n<li>Thickness adjustment and calibration<\/li>\n<li>Hardness\/fracture strength adjustment and calibration<\/li>\n<li>Diameter adjustment and calibration<\/li>\n<li>Length and width adjustment and calibration<\/li>\n<li>OZB adjustment and calibration<\/li>\n<li>Adjustment and calibration report<\/li>\n<li>Product setup<\/li>\n<li>Verification of test results<\/li>\n<li>Documented proof of operating personnel induction<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner]<div 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units We &hellip; <a href=\"https:\/\/www.kraemer-elektronik.com\/en\/service\/system-validation\/\">Continued<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"parent":2398,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_links_to":"","_links_to_target":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.13 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>System validation for tablet testers &amp; testing systems | KRAEMER ELEKTRONIK GmbH<\/title>\n<meta name=\"description\" content=\"Total Quality Management and audits: All tablet testing systems, including installation qualification, operational qualification, and performance qualification.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kraemer-elektronik.com\/en\/service\/system-validation\/\" \/>\n<meta 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