{"id":3642,"date":"2021-04-26T14:57:32","date_gmt":"2021-04-26T14:57:32","guid":{"rendered":"https:\/\/helmer-net.de\/?page_id=3642"},"modified":"2021-11-08T08:56:12","modified_gmt":"2021-11-08T08:56:12","slug":"fda-gmp-21-cfr-part11","status":"publish","type":"page","link":"https:\/\/helmer-net.de\/en\/industrieautomation\/fda-gmp-21-cfr-part11\/","title":{"rendered":"FDA GMP \/ 21 CFR Part11"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3642\" class=\"elementor elementor-3642 elementor-565\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-280c5da elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"280c5da\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8534610\" data-id=\"8534610\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4599f1d elementor-widget elementor-widget-text-editor\" data-id=\"4599f1d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Helmer Net Industrial Automation<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6615934 elementor-widget elementor-widget-heading\" data-id=\"6615934\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Helmer Net - FDA GMP \/ 21 CFR PART11<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c44e955 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c44e955\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1287ed8\" data-id=\"1287ed8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e41bf66 elementor-widget elementor-widget-spacer\" data-id=\"e41bf66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bdf7e69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bdf7e69\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8e7729a\" data-id=\"8e7729a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d1ac983 elementor-widget elementor-widget-heading\" data-id=\"d1ac983\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Effective. Reproducible. 100% tailor-made for your company<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a5c3dbd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a5c3dbd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8584465\" data-id=\"8584465\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ef77359 elementor-widget elementor-widget-spacer\" data-id=\"ef77359\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8ba2384 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8ba2384\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-956492d\" data-id=\"956492d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-41d2a6e elementor-widget elementor-widget-text-editor\" data-id=\"41d2a6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>VALIDATION OF PROCESSES<\/p><p>The objective here is to provide documented evidence that your process effectively and reproducibly delivers a product (result) that meets the specified quality requirements. With 21 CFR part 11, the FDA formulates requirements for electronic records and signatures that are also directed at medical device manufacturers.<\/p><p>Here, the law of the American health authority FDA 21 CRF Part 11, which has been in force since 1997, on &#8220;Electronic Records and Electronic Signatures&#8221; enables the transition from paper-based manual processes to computer-supported electronic processes.<\/p><p>We are happy to support you in this process and look forward to hearing from you.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5689f69 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5689f69\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-dc1386c\" data-id=\"dc1386c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3be6616 elementor-widget elementor-widget-spacer\" data-id=\"3be6616\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d1f8d72 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d1f8d72\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-16 elementor-top-column elementor-element elementor-element-d4c7a1b\" data-id=\"d4c7a1b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-4f7a309\" data-id=\"4f7a309\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a7417f0 elementor-widget elementor-widget-image\" data-id=\"a7417f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"2560\" height=\"1829\" src=\"https:\/\/helmer-net.de\/wp-content\/uploads\/2021\/06\/FDA-GMP-Helmer-Net-scaled.jpeg\" class=\"attachment-full size-full wp-image-5722\" alt=\"FDA GMP \/ 21 CFR PART 11 Helmer Net\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-16 elementor-top-column elementor-element elementor-element-6fb831e\" data-id=\"6fb831e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-65da3e7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"65da3e7\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0614d84\" data-id=\"0614d84\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dd5fbd7 elementor-widget elementor-widget-spacer\" data-id=\"dd5fbd7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6a9e2cb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6a9e2cb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6760146\" data-id=\"6760146\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-39243d9 elementor-widget elementor-widget-heading\" data-id=\"39243d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Find out about our services<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-92f6db5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"92f6db5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-dfa2a58\" data-id=\"dfa2a58\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-309466f elementor-widget elementor-widget-spacer\" data-id=\"309466f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2bf745e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2bf745e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e51bfc2\" data-id=\"e51bfc2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ef77ff4 elementor-widget elementor-widget-text-editor\" data-id=\"ef77ff4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3>Our services<\/h3><ul><li>\u2022 Central documentation for continuous monitoring<\/li><li>\u2022 Transparency at all times through periodic documentation<\/li><li>\u2022 No need for manual readout increases productivity<\/li><li>\u2022 Climatic conditions at a glance<\/li><li>\u2022 Internal and external quality requirements are met<\/li><li>\u2022 Everything traceable at all times<\/li><li>\u2022 Good Manufacturing Practice in medical technology<\/li><li>\u2022 Reduction of the effort required to achieve and maintain conformity<\/li><li>\u2022 use of innovations and new techniques<\/li><li>\u2022 Introduction of effective procedures for change and configuration management<\/li><li>\u2022 Validation Audit trails Document control Access protection<\/li><li>\u2022 Electronic records with digital signature<\/li><li>\u2022 Cleanroom operations<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-3de571e\" data-id=\"3de571e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8c2ed3a elementor--h-position-center elementor--v-position-middle elementor-arrows-position-inside elementor-pagination-position-inside elementor-widget elementor-widget-slides\" data-id=\"8c2ed3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;navigation&quot;:&quot;both&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;infinite&quot;:&quot;yes&quot;,&quot;transition&quot;:&quot;slide&quot;,&quot;transition_speed&quot;:500}\" data-widget_type=\"slides.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper\">\n\t\t\t\t\t<div class=\"elementor-slides-wrapper elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\" dir=\"ltr\" data-animation=\"fadeInUp\">\n\t\t\t\t<div class=\"swiper-wrapper elementor-slides\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-d111568 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><a class=\"swiper-slide-inner\" href=\"\/en\/kontakt\/\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Process validation<\/div><div class=\"elementor-slide-description\">Documented evidence and specific requirements for electronic records and signatures for medical device manufacturers.<\/div><div  class=\"elementor-button elementor-slide-button elementor-size-sm\">Contact us<\/div><\/div><\/a><\/div><div class=\"elementor-repeater-item-a52ab64 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><a class=\"swiper-slide-inner\" href=\"\/en\/kontakt\/\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Helmer Net validation concept<\/div><div class=\"elementor-slide-description\">We will be happy to create a validation concept for you and implement the FDA GMP \/ 21 CFR Part11 directive for you.<\/div><div  class=\"elementor-button elementor-slide-button elementor-size-sm\">Contact us<\/div><\/div><\/a><\/div><div class=\"elementor-repeater-item-f009870 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><a class=\"swiper-slide-inner\" href=\"\/en\/kontakt\/\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Helmer GmbH - Your expert for process validation.<\/div><div class=\"elementor-slide-description\">Find out about FDA GMP \/ 21 CFR Part11<\/div><div  class=\"elementor-button elementor-slide-button elementor-size-sm\">Contact us<\/div><\/div><\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Previous slide\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-left\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Next slide\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-chevron-right\"><\/i>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b2d95f5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b2d95f5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"aux-parallax-section elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f5e9405\" data-id=\"f5e9405\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b5cfa73 elementor-widget elementor-widget-spacer\" data-id=\"b5cfa73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Helmer Net Industrial Automation Helmer Net &#8211; FDA GMP \/ 21 CFR PART11 Effective. Reproducible. 100% tailor-made for your company VALIDATION OF PROCESSES The objective here is to provide documented evidence that your process effectively and reproducibly delivers a product (result) that meets the specified quality requirements. With 21 CFR part 11, the FDA formulates &#8230;<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":2616,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-3642","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/pages\/3642","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/comments?post=3642"}],"version-history":[{"count":0,"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/pages\/3642\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/pages\/2616"}],"wp:attachment":[{"href":"https:\/\/helmer-net.de\/en\/wp-json\/wp\/v2\/media?parent=3642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}