{"id":11820,"date":"2021-09-07T08:45:06","date_gmt":"2021-09-07T06:45:06","guid":{"rendered":"https:\/\/www.agilelabs.co.za\/?page_id=11820"},"modified":"2021-09-07T08:45:36","modified_gmt":"2021-09-07T06:45:36","slug":"software-validation-testing","status":"publish","type":"page","link":"https:\/\/www.agilelabs.co.za\/tr\/software-validation-testing\/","title":{"rendered":"Yaz\u0131l\u0131m Do\u011frulama ve Test Etme"},"content":{"rendered":"<p>Bulundu\u011funuz Yerde Uyumlulu\u011fu Sa\u011flay\u0131n<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Validasyon Planlama, Test ve Y\u00f6netim<\/h4>\n\n\n\n<p>Biz yaz\u0131l\u0131m uyumlulu\u011fu uzman\u0131y\u0131z. ProCalV5 yaz\u0131l\u0131m\u0131n\u0131n t\u00fcm s\u00fcr\u00fcmleri, yay\u0131nlanmadan \u00f6nce dahili olarak test edilir ve do\u011frulan\u0131r. IQ\/OQ\/PQ protokolleri sa\u011flanabilir. Lokasyonlar\u0131n\u0131zda uyumlu kullan\u0131m\u0131 sa\u011flamak i\u00e7in GAMP 5 seviye do\u011frulama proje planlar\u0131, gerekli t\u00fcm belgeler ve ihtiya\u00e7 duyulan hizmetler mevcuttur. Tipik da\u011f\u0131t\u0131mlar genellikle sekiz haftadan k\u0131sa s\u00fcrer.<\/p>\n\n\n\n<p><strong>Do\u011frulama planlama, test etme ve y\u00f6netim hizmetleri \u015funlar\u0131 i\u00e7erebilir:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VMP (Do\u011frulama Ana Plan\u0131)<\/li><li>Do\u011frulama beklentilerini belirleyin, bir\u00e7ok SDLC (Sistem Geli\u015ftirme Ya\u015fam D\u00f6ng\u00fcs\u00fc) \u00e7al\u0131\u015fmas\u0131, yetkilendirme ve y\u00f6nlendirme i\u00e7in VMP&#039;ye ba\u011fl\u0131d\u0131r<\/li><li>Risk de\u011ferlendirmesi<\/li><li>Gereksinim Testi \u00d6nceliklendirmesi i\u00e7in Rational<\/li><li>Test plan\u0131<\/li><li>Komut dosyalar\u0131n\u0131n geli\u015ftirilmesine net bir hedefle ba\u015flayabilmesi i\u00e7in test beklentilerini erken tan\u0131mlama, yanl\u0131\u015f y\u00f6nlendirme ve yanl\u0131\u015f ba\u015flang\u0131\u00e7lardan ka\u00e7\u0131nma<\/li><li>komut dosyas\u0131<\/li><li>Kaynak sa\u011flama<\/li><li>Test Y\u00fcr\u00fctme Deste\u011fi<\/li><li>Sapma \u00c7\u00f6z\u00fcn\u00fcrl\u00fc\u011f\u00fc<\/li><li>VSR (Do\u011frulama \u00d6zet Raporu)<\/li><li>Testleri, sapmalar\u0131, \u00e7\u00f6z\u00fcmleri ve riske dayal\u0131 istisnalar\u0131 \u00f6zetleyin<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibrasyon Programlar\u0131 i\u00e7in QSR ve GMP&#039;ye Genel Bak\u0131\u015f<\/h4>\n\n\n\n<p>\u0130\u015f operasyonlar\u0131n\u0131za yeni bir kalibrasyon program\u0131 uygularken, \u00fcretim uygulamalar\u0131n\u0131n yan\u0131 s\u0131ra kalite ve uygunluk uygulamalar\u0131 da dikkate al\u0131nmal\u0131d\u0131r. A\u015fa\u011f\u0131daki sorular\u0131 sorman\u0131n hedeflerinizi d\u00fczenlemenize yard\u0131mc\u0131 olabilece\u011fini g\u00f6rebilirsiniz.<\/p>\n\n\n\n<p><strong>\u015eartlar:<\/strong><br>GMP = \u0130yi \u00dcretim Uygulamalar\u0131<br>QSR = Kalite Sistem Y\u00f6netmeli\u011fi<\/p>\n\n\n\n<p><strong>Ekipman kalibrasyonu neden GMP\/QSR&#039;nin bir par\u00e7as\u0131d\u0131r?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bir \u00fcretici, t\u00fcm bitmi\u015f \u00fcr\u00fcnlerin \u015firketin cihaz\/ila\u00e7 ana kay\u0131t \u00f6zelliklerini kar\u015f\u0131lamas\u0131n\u0131 sa\u011flayan bir kalite sistemi geli\u015ftirmeli ve uygulamal\u0131d\u0131r.<\/li><li>Tasar\u0131m ve \u00fcretim s\u0131ras\u0131nda bile\u015fen, \u00fcr\u00fcn ve s\u00fcre\u00e7 parametrelerinin \u00f6l\u00e7\u00fclmesi de dahil olmak \u00fczere bir\u00e7ok y\u00f6nden g\u00fcvence elde edilir.<\/li><\/ul>\n\n\n\n<p><strong>\u00dcreticinin sorumluluklar\u0131 nelerdir?<\/strong><\/p>\n\n\n\n<p>Mekanik, elektronik, otomatik ve kimyasal ekipman dahil olmak \u00fczere t\u00fcm \u00fcretim ve QA test ekipmanlar\u0131n\u0131n a\u015fa\u011f\u0131daki \u00f6zelliklere sahip oldu\u011fundan emin olmak i\u00e7in:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Kullan\u0131m amac\u0131na uygun<\/li><li>Ge\u00e7erli sonu\u00e7lar \u00fcretebilen<\/li><li>E\u011fitimli \u00e7al\u0131\u015fanlar taraf\u0131ndan i\u015fletilmektedir<\/li><li>Uygun bir standarda kar\u015f\u0131 uygun \u015fekilde kalibre edilmi\u015f<\/li><\/ul>\n\n\n\n<p><strong>Prosed\u00fcrlere neler dahildir?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Ama\u00e7 ve Kapsam<\/li><li>Kalibrasyon s\u0131kl\u0131\u011f\u0131<\/li><li>Gerekli ekipman ve standartlar<\/li><li>Do\u011fruluk, kesinlik ve \u00f6nyarg\u0131 i\u00e7in s\u0131n\u0131rlar<\/li><li>Kalibrasyon i\u015fleminin a\u00e7\u0131klamas\u0131<\/li><li>D\u00fczeltici hareket<\/li><li>Belge gereksinimleri<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Ama\u00e7 ve Kapsam<\/h4>\n\n\n\n<p>Kalite G\u00fcvencesi, cihaz\/ila\u00e7 tasar\u0131m\u0131 ve proses parametrelerinin do\u011fruluk, kesinlik ve sapma i\u00e7in belirlenmi\u015f spesifikasyonlar dahilinde olmas\u0131n\u0131 sa\u011flamak i\u00e7in hangi \u00f6l\u00e7\u00fcmlerin gerekli oldu\u011funu belirlemelidir.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibrasyon S\u0131kl\u0131\u011f\u0131<\/h4>\n\n\n\n<p>Ekipman\u0131n tipine, kullan\u0131m s\u0131kl\u0131\u011f\u0131na ve \u00fcretim s\u00fcrecindeki kritikli\u011fine ba\u011fl\u0131d\u0131r. Ekipman\u0131n \u00e7al\u0131\u015fmas\u0131n\u0131 etkileyebilecek di\u011fer fakt\u00f6rler:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>S\u0131cakl\u0131k<\/li><li>Nem<\/li><li>Bula\u015fma<\/li><li>Statik elektrik<\/li><li>Manyetik alanlar<\/li><li>G\u00fc\u00e7 Kayna\u011f\u0131 Dalgalanmalar\u0131<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Ekipman ve Standartlar<\/h4>\n\n\n\n<p>Kullan\u0131lan t\u00fcm ekipman ve standartlar, cihaz\/ila\u00e7 ana dosyas\u0131nda veya kalite sistem kay\u0131tlar\u0131nda tam olarak tan\u0131mlanmal\u0131d\u0131r. Ekipman kalibre edilirken ve kullan\u0131l\u0131rken s\u0131cakl\u0131k, nem, titre\u015fim ve temizlik gibi \u00e7evresel \u00f6zellikler dikkate al\u0131nmal\u0131d\u0131r.<\/p>\n\n\n\n<p><strong>Te\u00e7hizat<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Kurulum Kalifikasyonu (IQ): ekipman ve yard\u0131mc\u0131 sistemlerin do\u011fru \u015fekilde kuruldu\u011fundan, \u00fcreticilerin spesifikasyonlar\u0131n\u0131 ve tasar\u0131m ama\u00e7lar\u0131n\u0131 kar\u015f\u0131lad\u0131\u011f\u0131ndan, ama\u00e7lanan kullan\u0131m aral\u0131\u011f\u0131nda uygun \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131ndan emin olmak i\u00e7in al\u0131nan eylem<\/li><li>Operasyonel Yeterlilik (OQ): ekipman ve alt sistemlerin, belirlenmi\u015f limitler ve toleranslar dahilinde tutarl\u0131 bir \u015fekilde \u00e7al\u0131\u015fabilme yetene\u011fine sahip olmas\u0131n\u0131 sa\u011flamak i\u00e7in al\u0131nan eylem<\/li><li>Performans Kalifikasyonu (PQ): Bir sistemdeki ekipman\u0131n zaman i\u00e7inde etkin ve tutarl\u0131 bir \u015fekilde \u00e7al\u0131\u015fmas\u0131n\u0131 sa\u011flamak i\u00e7in al\u0131nan eylem<\/li><\/ul>\n\n\n\n<p><strong>Ekipman ve Standartlar<\/strong><\/p>\n\n\n\n<p>Uygulanabilir oldu\u011funda, standartlar ulusal Standartlar Enstit\u00fcs\u00fc&#039;ne g\u00f6re izlenebilir olmal\u0131d\u0131r ve<br>teknoloji (NIST).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u00d6zel standartlar kalibrasyon i\u00e7in NIST&#039;e g\u00f6nderilir ve iade edilir<\/li><li>NIST, kalibrasyon program\u0131nda kullan\u0131lacak standart referans malzemeleri sa\u011flar<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Do\u011fruluk, Kesinlik ve Sapma i\u00e7in Limitler<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>&nbsp;Do\u011fruluk: Bir enstr\u00fcman\u0131n ger\u00e7ek veya mutlak de\u011feri elde etme yetene\u011finin \u00f6l\u00e7\u00fcs\u00fc<\/li><li>Kesinlik: g\u00f6reli tekrarlanabilirlik derecesini g\u00f6sterir<\/li><li>\u00d6nyarg\u0131: Bir dizi \u00f6l\u00e7\u00fcmdeki ortalama de\u011ferin ger\u00e7ek de\u011fere ne kadar yakla\u015ft\u0131\u011f\u0131n\u0131n bir \u00f6l\u00e7\u00fcs\u00fc<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">D\u00fczeltici hareket<\/h4>\n\n\n\n<p>S\u0131n\u0131rlar kar\u015f\u0131lanmad\u0131\u011f\u0131nda ger\u00e7ekle\u015fir. \u0130yile\u015ftirici eylem a\u015fa\u011f\u0131daki h\u00fck\u00fcmleri i\u00e7ermelidir:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bu limitleri yeniden belirlemek i\u00e7in gereken her t\u00fcrl\u00fc eylemi tan\u0131mlay\u0131n ve ba\u015flat\u0131n (yeniden kalibrasyon)<\/li><li>Cihaz\/ila\u00e7 kalitesi \u00fczerinde herhangi bir olumsuz etki olup olmad\u0131\u011f\u0131n\u0131 de\u011ferlendirin<\/li><li>Al\u0131nan t\u00fcm eylemleri ve yap\u0131lan de\u011ferlendirmeleri belgeleyin<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Belge Gereksinimleri<\/h4>\n\n\n\n<p>Ka\u011f\u0131t sistemi veya yaz\u0131l\u0131m program\u0131:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Ekipman tan\u0131mlamas\u0131 (model numaras\u0131 dahil)<\/li><li>Seri numaras\u0131<\/li><li>Kalibrasyon tarihi<\/li><li>Kalibrat\u00f6r\u00fcn ad\u0131<\/li><li>Bir sonraki kalibrasyon tarihi<\/li><li>Kalibrasyon \u00f6zellikleri<\/li><li>mfr adresi (iste\u011fe ba\u011fl\u0131)<\/li><li>Kalibrasyon nedeni (iste\u011fe ba\u011fl\u0131)<\/li><li>Yorumlar (iste\u011fe ba\u011fl\u0131)<\/li><li>D\u0131\u015f hizmet bilgisi (iste\u011fe ba\u011fl\u0131)<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibrasyon Personeli<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Kalibrasyon yapmak i\u00e7in e\u011fitim ve\/veya deneyim yoluyla yeterince e\u011fitilmi\u015f olmal\u0131d\u0131r.<\/li><li>Temel metroloji ve kalibrasyon kavramlar\u0131 bilgisine sahip olmal\u0131d\u0131r.<\/li><li>\u00d6l\u00e7\u00fcm disiplinlerinin temel ilkelerini, i\u015fleme ad\u0131mlar\u0131n\u0131 ve kabul gerekliliklerini anlay\u0131n<\/li><li>Genel kalibrasyon program\u0131 hakk\u0131nda bilgi<\/li><li>Bak\u0131m ve ekipman kullan\u0131m\u0131 ile ilgili talimatlar\u0131 takip edebilme<\/li><li>vicdanl\u0131 tutum<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Uyumlulu\u011fun Onaylanmas\u0131<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Kalibrasyon Program\u0131n\u0131n Denetimi<\/li><li>\u0130\u00e7 denetimler (QSR taraf\u0131ndan gerekli k\u0131l\u0131n\u0131r)<\/li><li>Uygun bir program s\u00fcrd\u00fcrmek<\/li><li>Uygun dok\u00fcmantasyonun s\u00fcrd\u00fcr\u00fclmesi<\/li><li>Standartlar\u0131n uygun bak\u0131m\u0131<\/li><li>\u0130yile\u015ftirici eylemlerin yeterlili\u011fi<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">D\u0131\u015f Denetimler<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>FDA, s\u00f6zle\u015fmeli laboratuvarlar\u0131 bir \u00fcreticinin GMP program\u0131n\u0131n bir uzant\u0131s\u0131 olarak de\u011ferlendirir, bu nedenle periyodik olarak uygundur<\/li><li>\u0130zlenebilir standartlar kullan\u0131larak ekipman\u0131n kontroll\u00fc ko\u015fullar alt\u0131nda kalibre edildi\u011fini do\u011frulayan belgeler elde edin<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Ek Endi\u015feler<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>\u00dcretim s\u00fcrecinde kullan\u0131lan \u00fcretim ekipman\u0131 (otomatikle\u015ftirilmi\u015fse) periyodik olarak kalibre edilmelidir<\/li><li>Bilgisayar kontroll\u00fc \u00fcretim ekipman\u0131, kullan\u0131m amac\u0131 i\u00e7in do\u011frulanmal\u0131 ve bir kalibrasyon program\u0131na dahil edilmelidir.<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Tan\u0131mlar\u0131n eki<\/h4>\n\n\n\n<p><strong>Kurulum Kalifikasyonu (IQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u0130stedi\u011fini ald\u0131n m\u0131?<\/li><li>Kullanmak i\u00e7in uygun olanaklara sahip misiniz?<\/li><li>T\u00fcm ekipman uygun \u015fekilde hesapland\u0131 m\u0131:<ul><li>Seri numaras\u0131<\/li><li>\u00dcretici firma<\/li><li>\u015eirket i\u00e7i varl\u0131k numaras\u0131<\/li><li>Uygun kurulum<\/li><li>Enstr\u00fcman kay\u0131t defteri yerinde<\/li><li>Laboratuvar konumu<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Operasyonel Yeterlilik (OQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Laboratuvar ekipman\u0131n\u0131n beklenen kullan\u0131m aral\u0131klar\u0131nda performans g\u00f6sterdi\u011fini do\u011frulayan belgeler<\/li><li>Bir enstr\u00fcman\u0131n\/sistemin \u00f6nceden belirlenmi\u015f bir dizi kriter s\u0131n\u0131rlar\u0131 dahilinde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 garanti alt\u0131na almak i\u00e7in bir dizi fonksiyonel test<\/li><\/ul>\n\n\n\n<p><strong>Performans Kalifikasyonu (PQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Belirli bir y\u00f6ntem parametreleri k\u00fcmesinin, ge\u00e7mi\u015f y\u00f6ntem do\u011frulamas\u0131na g\u00f6re d\u00fczg\u00fcn \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 g\u00f6sterir.<\/li><li>Baz\u0131 durumlarda Sistem Uygunlu\u011fu, Performans Kalifikasyonu olarak kabul edilebilir.<br>Yeniden Yeterlilik (RQ):<\/li><li>Onar\u0131mdan, sat\u0131c\u0131 servisinden, yer de\u011fi\u015fikli\u011finden veya ayarlamalardan sonra bir enstr\u00fcman\u0131n beklendi\u011fi ve ama\u00e7land\u0131\u011f\u0131 gibi \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belirlenmesi<\/li><li>Hususlar<ul><li>Cihaz kurulan orijinal protokolleri kar\u015f\u0131l\u0131yor mu?<\/li><li>De\u011filse, hangi kararlar al\u0131nmal\u0131d\u0131r?<\/li><\/ul><\/li><\/ul>","protected":false},"excerpt":{"rendered":"<p>Ensure Compliance At Your Location Validation Planning, Testing And Management We are software compliance experts. All versions of ProCalV5 software are internally tested and validated before release. IQ\/OQ\/PQ protocols can be provided. GAMP 5 level validation project plans, all necessary documents and any needed services are available to ensure compliant use at your locations. 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