{"id":11026,"date":"2022-05-20T14:21:22","date_gmt":"2022-05-20T12:21:22","guid":{"rendered":"http:\/\/staging.blogs.yokogawa.de\/chemical-pharma\/?p=11026"},"modified":"2022-07-21T12:07:11","modified_gmt":"2022-07-21T10:07:11","slug":"proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir","status":"publish","type":"post","link":"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/","title":{"rendered":"Proses izlemeden &#8211; raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r?"},"content":{"rendered":"<h3>\u0130la\u00e7 end\u00fcstrisinde faaliyet g\u00f6steren bir \u00fcretim tesisinin en k\u00f6t\u00fc senaryolar\u0131ndan biri;.<\/h3>\n<p>D\u00fczenleyici kurulu\u015f taraf\u0131ndan y\u00fcr\u00fct\u00fclen kalite denetimi esnas\u0131nda denet\u00e7i, ila\u00e7 \u00fcretiminde kritik proses de\u011ferlerinin izlenmesi ve kaydedilmesi i\u00e7in kullan\u0131lan bilgisayar sisteminde baz\u0131 g\u00fcvenlik a\u00e7\u0131klar\u0131 veya kusurlar bulur. D\u00fc\u015f\u00fck risk i\u00e7eren k\u00fc\u00e7\u00fck meselelerde denet\u00e7i sizi bir iyile\u015ftirme plan\u0131 yapmaya zorlayabilir. B\u00fcy\u00fck meseleler s\u00f6z konusu olmas\u0131 durumunda ise d\u00fczenleyici kurulu\u015f resmi bir uyar\u0131 yaz\u0131s\u0131 g\u00f6nderebilir ve hatta \u00fcretim tesisinin derhal kapat\u0131lmas\u0131na karar verebilir. G\u00fcn\u00fcm\u00fczde ihlallerin \u00f6nemli bir k\u0131sm\u0131 veri b\u00fct\u00fcnl\u00fc\u011f\u00fcyle ilgilidir.<\/p>\n<p>Ge\u00e7ti\u011fimiz y\u00fczy\u0131lda i\u015fler kolayd\u0131. End\u00fcstride prosese yak\u0131n konumda yerle\u015ftirilmi\u015f ba\u011f\u0131ms\u0131z grafik kaydediciler kullan\u0131yordu. Yaln\u0131zca operat\u00f6r\u00fcn kay\u0131t cihaz\u0131na fiziksel eri\u015fimi vard\u0131 ve trend grafi\u011fi bir kere k\u00e2\u011f\u0131da bas\u0131ld\u0131\u011f\u0131nda, verilerin de\u011fi\u015ftirilmesi art\u0131k m\u00fcmk\u00fcn olmuyordu.<br \/>\nK\u00e2\u011f\u0131ttan, ka\u011f\u0131ts\u0131z \u00e7\u00f6z\u00fcmlere ge\u00e7i\u015fle birlikte 21 CFR b\u00f6l\u00fcm 11 ile uygunluk ve Bilgisayarl\u0131 Sistem Do\u011frulamas\u0131 gibi yeni d\u00fczenlemeler de zorunlu hale geldi. Ancak daha sonra, IT a\u011f teknolojisi de \u00fcretim kat\u0131na girdi ve t\u00fcm bilgisayarl\u0131 sistemleri entegre etme ve merkezile\u015ftirme e\u011filiminin ba\u015flamas\u0131na neden oldu. Bu da farkl\u0131 kullan\u0131c\u0131lar\u0131n uzaktan eri\u015fimi ve veri payla\u015f\u0131m\u0131 verimlili\u011fini art\u0131rd\u0131 ve \u00fcretim maliyetlerini d\u00fc\u015f\u00fcrd\u00fc.<br \/>\nFakat ayn\u0131 zamanda, sistemin sahibi kim, verilerden, sistemin bak\u0131m\u0131ndan ve en \u00f6nemlisi de sistemin g\u00fcvenli\u011finden kim sorumlu gibi yeni sorular ortaya \u00e7\u0131kt\u0131.\u00a0 \u0130la\u00e7 end\u00fcstrisindeki bilgisayarl\u0131 sistemlerin geli\u015ftirilmesi ve kullan\u0131lmas\u0131na y\u00f6nelik k\u0131lavuzlar da daha fazla de\u011ferlendirildi ve bu, ALCOA k\u0131saltmas\u0131 alt\u0131nda ger\u00e7ekle\u015fti\u011fi \u00fczere veri b\u00fct\u00fcnl\u00fc\u011f\u00fcne g\u00fc\u00e7l\u00fc bir odaklanmayla sonu\u00e7land\u0131 (resme bak\u0131n)<\/p>\n<p><img decoding=\"async\" class=\" wp-image-17102 aligncenter\" src=\"https:\/\/www.yokogawa.com\/eu\/blog\/app\/uploads\/sites\/8\/2022\/06\/ALCOA.jpg\" alt=\"\" width=\"573\" height=\"323\" \/>D\u00fczenlenmi\u015f end\u00fcstrilerin \u00f6nde gelen proses izleme sistemleri tedarik\u00e7isi ve \u00fcreticisi olarak Yokogawa, veri b\u00fct\u00fcnl\u00fc\u011f\u00fc i\u00e7in h\u00e2l\u00e2 k\u00e2\u011f\u0131ts\u0131z kay\u0131t cihazlar\u0131 konseptine ve g\u00fcc\u00fcne inanmaktad\u0131r.<br \/>\nVeri b\u00fct\u00fcnl\u00fc\u011f\u00fc, Yokogawa \u00f6rne\u011finde Windows olmayan bir \u0130\u015fletim Sistemini temel alan sistemin tasarlanmas\u0131yla ba\u015flar. Bu, bilgisayarlarda vir\u00fcs\u00fcn veya k\u00f6t\u00fc ama\u00e7l\u0131 kod riskinin en aza indirildi\u011fi anlam\u0131na gelir. Smartdac+ k\u00e2\u011f\u0131ts\u0131z kay\u0131t cihaz\u0131, donan\u0131m ve yaz\u0131l\u0131m (donan\u0131m yaz\u0131l\u0131m\u0131) bile\u015fenlerinin tam entegrasyonunu i\u00e7eren amaca uygun bir sistemdir. Bu da do\u011frulama \u00e7al\u0131\u015fmalar\u0131n\u0131n azalmas\u0131n\u0131 sa\u011flar.<br \/>\nYerel operasyon ve yerel veri depolama, sistem sahipli\u011fi ve veri sahipli\u011fi a\u00e7\u0131s\u0131ndan eski grafik kay\u0131t cihaz\u0131yla ayn\u0131 avantajlar\u0131 sunar. \u0130la\u00e7 d\u00fczenlemelerine uyum i\u00e7in geli\u015fmi\u015f g\u00fcvenlik se\u00e7ene\u011fi kullan\u0131l\u0131r. Uzaktan eri\u015fim ve dosya aktar\u0131m\u0131 i\u00e7in s\u0131k\u0131 kullan\u0131c\u0131 eri\u015fim kontrol\u00fc ve yerel alan a\u011f\u0131na g\u00fcvenli ba\u011flant\u0131 sa\u011flar. Veri B\u00fct\u00fcnl\u00fc\u011f\u00fcne ili\u015fkin iyi uygulamalar, sisteme eri\u015fim i\u00e7in rollerin nas\u0131l ayr\u0131laca\u011f\u0131n\u0131 tarif eder.<\/p>\n<h3>Yokogawa, Veri B\u00fct\u00fcnl\u00fc\u011f\u00fc \u00f6zelliklerini g\u00fc\u00e7lendirmi\u015ftir.<\/h3>\n<p>Smartdac sistemlerimizin en son donan\u0131m yaz\u0131l\u0131m\u0131 s\u00fcr\u00fcm\u00fc, IT y\u00f6neticisi ve OT y\u00f6neticisinin farkl\u0131 sorumluluklar\u0131na hizmet eden \u0130kinci Y\u00f6netici d\u00fczeyini destekler. Bu \u015fekilde, OT y\u00f6neticisi kay\u0131t cihaz\u0131 uygulamas\u0131ndan ve IT y\u00f6neticisi ise sistemin Kullan\u0131c\u0131\/Parola y\u00f6netiminden sorumlu olur.<\/p>\n<h3>Sa\u011flaml\u0131k \u00fczerine, verilerin de\u011fi\u015ftirilmesi \u00fczerine.<\/h3>\n<p>\u0130kili kodlanm\u0131\u015f veri dosyas\u0131 yaln\u0131zca \u00f6l\u00e7\u00fcm de\u011ferlerini de\u011fil, ayn\u0131 zamanda ger\u00e7ek kay\u0131t cihaz\u0131 yap\u0131land\u0131rmas\u0131 ve denetim tarih\u00e7esi (kim, ne zaman, ne) gibi meta verileri de i\u00e7erir. Orijinal veri dosyas\u0131 olu\u015fturulur ve kay\u0131t cihaz\u0131n\u0131n dahili belle\u011finde saklan\u0131r. Ger\u00e7ek kopyalar harici bellekte (SD kart) saklan\u0131r ve ayr\u0131ca a\u011fdaki merkezi dosya sunucusuna g\u00f6nderilir. Elektrik kesintisi veya a\u011f ba\u011flant\u0131s\u0131n\u0131n kesilmesi durumunda orijinal veri dosyalar\u0131 kaybolmaz.<br \/>\nYokogawa G\u00f6r\u00fcnt\u00fcleyici yaz\u0131l\u0131m\u0131, kay\u0131t cihaz\u0131 veri dosyas\u0131n\u0131n do\u011frulanmas\u0131 i\u00e7in\u00a0 veri dosyas\u0131 b\u00fct\u00fcnl\u00fck kontrol\u00fc uygular. Veri dosyas\u0131ndaki herhangi bir de\u011fi\u015fiklik, onun art\u0131k orijinal veri dosyas\u0131 olmad\u0131\u011f\u0131n\u0131n g\u00f6sterilmesiyle sonu\u00e7lan\u0131r. Yaz\u0131l\u0131m tasar\u0131m politikam\u0131z uyumlulu\u011fu sa\u011flar, yani en son s\u00fcr\u00fcmle bile 20 y\u0131ldan daha uzun s\u00fcre \u00f6nce yay\u0131nlanm\u0131\u015f elektronik veri dosyalar\u0131 bir Yokogawa k\u00e2\u011f\u0131ts\u0131z kay\u0131t cihaz\u0131yla a\u00e7\u0131labilir (muhafaza, orijinal format\u0131 koruma)<\/p>\n<p>\u00d6zellikle ila\u00e7 end\u00fcstrisi i\u00e7in ka\u011f\u0131ts\u0131z kay\u0131t cihaz\u0131 h\u00e2l\u00e2 \u00e7ok g\u00fc\u00e7l\u00fc bir konsepttir. Ge\u00e7mi\u015fin, bug\u00fcn\u00fcn ve gelece\u011fin ihtiya\u00e7lar\u0131n\u0131n kar\u015f\u0131lanmas\u0131na hizmet eder. En son donan\u0131m yaz\u0131l\u0131m\u0131 s\u00fcr\u00fcm\u00fc, 21 CFR b\u00f6l\u00fcm 11 ve veri b\u00fct\u00fcnl\u00fc\u011f\u00fc gereksinimleriyle uyumludur. Bu, FDA denetiminin stres yaratmayaca\u011f\u0131 ve denet\u00e7inin memnuniyetle kar\u015f\u0131lanaca\u011f\u0131 anlam\u0131na gelir.<\/p>\n<hr \/>\n<blockquote class=\"wp-embedded-content\" data-secret=\"Z3PzM2Z2YG\"><p><a href=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/safety-security-en\/yokogawa-oprex-cevre-izleme-takip-sistemi\/\">Yokogawa OpreX \u00c7evre \u0130zleme (Takip) Sistemi<\/a><\/p><\/blockquote>\n<p><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Yokogawa OpreX \u00c7evre \u0130zleme (Takip) Sistemi&#8221; &#8212; Chemical Pharma Blog\" src=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/safety-security-en\/yokogawa-oprex-cevre-izleme-takip-sistemi\/embed\/#?secret=C8exRYJqVq#?secret=Z3PzM2Z2YG\" data-secret=\"Z3PzM2Z2YG\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"1NBfDHGz61\"><p><a href=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/optimizasyon\/iyi-veri-iyi-para-demek-mi\/\">\u0130yi veri iyi para demek mi?<\/a><\/p><\/blockquote>\n<p><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;\u0130yi veri iyi para demek mi?&#8221; &#8212; Chemical Pharma Blog\" src=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/optimizasyon\/iyi-veri-iyi-para-demek-mi\/embed\/#?secret=6qmn6whNs3#?secret=1NBfDHGz61\" data-secret=\"1NBfDHGz61\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Veri b\u00fct\u00fcnl\u00fc\u011f\u00fc, Yokogawa kay\u0131t cihaz\u0131 \u00f6rne\u011finde Windows olmayan bir i\u015fletim sistemine dayanan sistemin tasar\u0131m\u0131yla ba\u015flar. Bu, bilgisayar vir\u00fcs\u00fc veya k\u00f6t\u00fc ama\u00e7l\u0131 kod riskinin en aza indirilmesi anlam\u0131na gelir. SMARTDAC+ ka\u011f\u0131ts\u0131z kay\u0131t cihaz\u0131, donan\u0131m ve yaz\u0131l\u0131m bile\u015fenlerinin (firmware) tam entegrasyonuna sahip&hellip; <\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\"> <span class=\"screen-reader-text\">Proses izlemeden &#8211; raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r?<\/span> Devam\u0131 &raquo;<\/a><\/p>\n","protected":false},"author":157,"featured_media":10388,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"","footnotes":""},"categories":[2061,2058],"tags":[2310,2311],"coauthors":[943],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.13 (Yoast SEO v20.13) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Proses izlemeden - raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r? - Chemical Pharma Blog<\/title>\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.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Proses izlemeden - raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r?\" \/>\n<meta property=\"og:description\" content=\"Veri b\u00fct\u00fcnl\u00fc\u011f\u00fc, Yokogawa kay\u0131t cihaz\u0131 \u00f6rne\u011finde Windows olmayan bir i\u015fletim sistemine dayanan sistemin tasar\u0131m\u0131yla ba\u015flar. Bu, bilgisayar vir\u00fcs\u00fc veya k\u00f6t\u00fc ama\u00e7l\u0131 kod riskinin en aza indirilmesi anlam\u0131na gelir. SMARTDAC+ ka\u011f\u0131ts\u0131z kay\u0131t cihaz\u0131, donan\u0131m ve yaz\u0131l\u0131m bile\u015fenlerinin (firmware) tam entegrasyonuna sahip&hellip;  Proses izlemeden &#8211; raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r? Devam\u0131 &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\" \/>\n<meta property=\"og:site_name\" content=\"Chemical Pharma Blog\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-20T12:21:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-07-21T10:07:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.yokogawa.com\/eu\/blog\/app\/uploads\/sites\/8\/2022\/06\/AdobeStock_198400062-scaled-1.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1709\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Marco Bischoff\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\"},\"author\":{\"name\":\"Marco Bischoff\",\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/#\/schema\/person\/e2152b7e9b806fd87e6f90b31a6abd8d\"},\"headline\":\"Proses izlemeden &#8211; raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r?\",\"datePublished\":\"2022-05-20T12:21:22+00:00\",\"dateModified\":\"2022-07-21T10:07:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\"},\"wordCount\":887,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/#organization\"},\"keywords\":[\"end\u00fcstrisinde\",\"Proses izlemeden\"],\"articleSection\":[\"Optimizasyon\",\"Otomasyon\"],\"inLanguage\":\"tr\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\",\"url\":\"https:\/\/www.yokogawa.com\/eu\/blog\/chemical-pharma\/tr\/proses-izlemeden-raporlamaya-ilac-endustrisinde-veri-butunlugu-nasil-saglanir\/\",\"name\":\"Proses izlemeden - raporlamaya: \u0130la\u00e7 end\u00fcstrisinde veri b\u00fct\u00fcnl\u00fc\u011f\u00fc nas\u0131l sa\u011flan\u0131r? 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