{"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\/sv\/software-validation-testing\/","title":{"rendered":"Validering och testning av programvara"},"content":{"rendered":"<p>S\u00e4kerst\u00e4ll \u00f6verensst\u00e4mmelse p\u00e5 din plats<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Valideringsplanering, testning och hantering<\/h4>\n\n\n\n<p>Vi \u00e4r experter p\u00e5 \u00f6verensst\u00e4mmelse med programvara. Alla versioner av ProCalV5 -programvaran testas internt och valideras innan de sl\u00e4pps. IQ\/OQ\/PQ -protokoll kan tillhandah\u00e5llas. Verifieringsprojektplaner f\u00f6r GAMP 5 -niv\u00e5, alla n\u00f6dv\u00e4ndiga dokument och alla n\u00f6dv\u00e4ndiga tj\u00e4nster \u00e4r tillg\u00e4ngliga f\u00f6r att s\u00e4kerst\u00e4lla kompatibelt bruk p\u00e5 dina platser. Typiska distributioner tar vanligtvis mindre \u00e4n \u00e5tta veckor.<\/p>\n\n\n\n<p><strong>Valideringsplanering, testning och f\u00f6rvaltningstj\u00e4nster kan innefatta:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>VMP (Valideringsplan)<\/li><li>St\u00e4ll in valideringsf\u00f6rv\u00e4ntningar, m\u00e5nga SDLC -insatser (System Development Life Cycle) \u00e4r beroende av VMP f\u00f6r auktorisering och riktning<\/li><li>Riskbed\u00f6mning<\/li><li>Rationell f\u00f6r krav Test av prioritering<\/li><li>Testplan<\/li><li>Definiera testf\u00f6rv\u00e4ntningar tidigt s\u00e5 att utveckling av manus kan startas med ett tydligt m\u00e5l, undvika felriktning och falska starter<\/li><li>Scripting<\/li><li>Resourcing<\/li><li>Support f\u00f6r testk\u00f6rning<\/li><li>Avvikelseuppl\u00f6sning<\/li><li>VSR (Valideringssammanfattningsrapport)<\/li><li>Sammanfatta tester, avvikelser, uppl\u00f6sningar och riskbaserade undantag<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">QSR- och GMP -\u00f6versikt f\u00f6r kalibreringsprogram<\/h4>\n\n\n\n<p>N\u00e4r du implementerar ett nytt kalibreringsprogram i din aff\u00e4rsverksamhet b\u00f6r kvalitet och efterlevnadspraxis beaktas tillsammans med tillverkningspraxis. Du kanske hittar fr\u00e5gorna nedan kan hj\u00e4lpa dig att organisera dina m\u00e5l.<\/p>\n\n\n\n<p><strong>Villkor:<\/strong><br>GMP = Good Manufacturing Practices<br>QSR = Quality System Regulation<\/p>\n\n\n\n<p><strong>Varf\u00f6r \u00e4r utrustningskalibrering en del av GMP\/QSR?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>En tillverkare m\u00e5ste utveckla och implementera ett kvalitetssystem som s\u00e4kerst\u00e4ller att alla f\u00e4rdiga produkter uppfyller f\u00f6retagets specifikationer f\u00f6r enhet\/l\u00e4kemedel.<\/li><li>F\u00f6rs\u00e4kran erh\u00e5lls p\u00e5 m\u00e5nga s\u00e4tt, inklusive m\u00e4tning av komponent-, produkt- och processparametrar under design och produktion.<\/li><\/ul>\n\n\n\n<p><strong>Vilket ansvar har tillverkaren?<\/strong><\/p>\n\n\n\n<p>F\u00f6r att s\u00e4kerst\u00e4lla att all produktions- och QA -testutrustning, inklusive mekanisk, elektronisk, automatiserad och kemisk utrustning, \u00e4r:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>L\u00e4mplig f\u00f6r avsedd anv\u00e4ndning<\/li><li>Kan producera giltiga resultat<\/li><li>Drivs av utbildade medarbetare<\/li><li>Korrekt kalibrerad kontra en l\u00e4mplig standard<\/li><\/ul>\n\n\n\n<p><strong>Vad ing\u00e5r i f\u00f6rfarandena?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Syfte och omfattning<\/li><li>Kalibreringsfrekvens<\/li><li>Utrustning och standarder kr\u00e4vs<\/li><li>Gr\u00e4nser f\u00f6r noggrannhet, precision och f\u00f6rdom<\/li><li>En beskrivning av kalibreringsprocessen<\/li><li>\u00c5tg\u00e4rd<\/li><li>Dokumentationskrav<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Syfte och omfattning<\/h4>\n\n\n\n<p>Kvalitetss\u00e4kring b\u00f6r avg\u00f6ra vilka m\u00e4tningar som \u00e4r n\u00f6dv\u00e4ndiga f\u00f6r att s\u00e4kerst\u00e4lla att enhets-\/l\u00e4kemedelsdesign och processparametrar ligger inom fastst\u00e4llda specifikationer f\u00f6r noggrannhet, precision och f\u00f6rsp\u00e4nning.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibreringsfrekvens<\/h4>\n\n\n\n<p>Beroende p\u00e5 utrustningstyp, anv\u00e4ndningsfrekvens och dess kritik i tillverkningsprocessen. Andra faktorer som kan p\u00e5verka utrustningens funktion:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Temperatur<\/li><li>Fuktighet<\/li><li>F\u00f6rorening<\/li><li>Statisk elektricitet<\/li><li>Magnetiska f\u00e4lt<\/li><li>Str\u00f6mf\u00f6rs\u00f6rjningsfluktuationer<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Utrustning och standarder<\/h4>\n\n\n\n<p>All utrustning och standarder som anv\u00e4nds b\u00f6r beskrivas fullst\u00e4ndigt i enhets-\/l\u00e4kemedelsm\u00e4starfilen eller kvalitetssystemet. Milj\u00f6egenskaper som temperatur, fuktighet, vibrationer och renhet m\u00e5ste beaktas vid kalibrering och anv\u00e4ndning av utrustning.<\/p>\n\n\n\n<p><strong>Utrustning<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Installationskvalifikation (IQ): \u00e5tg\u00e4rder som vidtas f\u00f6r att s\u00e4kerst\u00e4lla att utrustning och tillh\u00f6rande system \u00e4r korrekt installerade, uppfyller tillverkarnas specifikationer och konstruktionsavsikter, fungerar p\u00e5 l\u00e4mpligt s\u00e4tt i det avsedda anv\u00e4ndningsomr\u00e5det<\/li><li>Operationell kvalifikation (OQ): \u00e5tg\u00e4rder som vidtas f\u00f6r att s\u00e4kerst\u00e4lla att utrustning och delsystem kan fungera konsekvent inom fastst\u00e4llda gr\u00e4nser och toleranser<\/li><li>Prestationskvalificering (PQ): \u00e5tg\u00e4rder som vidtas f\u00f6r att s\u00e4kerst\u00e4lla att utrustning i ett system fungerar effektivt och konsekvent \u00f6ver tid<\/li><\/ul>\n\n\n\n<p><strong>Utrustning och standarder<\/strong><\/p>\n\n\n\n<p>Om det \u00e4r praktiskt b\u00f6r standarder sp\u00e5ras till National Institute of Standards och<br>teknik (NIST).<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Privata standarder skickas till NIST f\u00f6r kalibrering och returneras<\/li><li>NIST tillhandah\u00e5ller standardreferensmaterial som ska anv\u00e4ndas i kalibreringsprogrammet<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Gr\u00e4nser f\u00f6r noggrannhet, precision och f\u00f6rdom<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>&nbsp;Noggrannhet: m\u00e5ttet p\u00e5 instrumentets f\u00f6rm\u00e5ga att erh\u00e5lla det sanna eller absoluta v\u00e4rdet<\/li><li>Precision: anger den relativa graden av repeterbarhet<\/li><li>Bias: ett m\u00e5tt p\u00e5 hur n\u00e4ra medelv\u00e4rdet i en serie m\u00e4tningar n\u00e4rmar sig det verkliga v\u00e4rdet<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">\u00c5tg\u00e4rd<\/h4>\n\n\n\n<p>Utg\u00e5r n\u00e4r gr\u00e4nserna inte \u00e4r uppfyllda. Avhj\u00e4lpande \u00e5tg\u00e4rder b\u00f6r inneh\u00e5lla f\u00f6ljande best\u00e4mmelser:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Beskriv och initiera alla \u00e5tg\u00e4rder som kr\u00e4vs f\u00f6r att \u00e5teruppr\u00e4tta dessa gr\u00e4nser (omkalibrering)<\/li><li>Utv\u00e4rdera om det fanns n\u00e5gon negativ effekt p\u00e5 enhetens\/l\u00e4kemedlets kvalitet<\/li><li>Dokumentera eventuella \u00e5tg\u00e4rder och utv\u00e4rderingar<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Dokumentationskrav<\/h4>\n\n\n\n<p>Papperssystem eller programvara:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Utrustningsidentifiering (inklusive modellnummer)<\/li><li>Serienummer<\/li><li>Kalibreringsdatum<\/li><li>Kalibratorns namn<\/li><li>Datum f\u00f6r n\u00e4sta kalibrering<\/li><li>Kalibreringsspecifikationer<\/li><li>Adress till mfr (valfritt)<\/li><li>Anledning till kalibrering (valfritt)<\/li><li>Kommentarer (valfritt)<\/li><li>Utanf\u00f6r serviceinformation (tillval)<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Kalibreringspersonal<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>M\u00e5ste vara tillr\u00e4ckligt utbildad genom utbildning och\/eller erfarenhet f\u00f6r att utf\u00f6ra kalibreringar.<\/li><li>B\u00f6r ha en grundl\u00e4ggande kunskap om metrologi och kalibreringskoncept<\/li><li>Ha f\u00f6rst\u00e5else f\u00f6r de grundl\u00e4ggande principerna f\u00f6r m\u00e4tningsdiscipliner, bearbetningssteg och acceptationskrav<\/li><li>Kunskap om det \u00f6vergripande kalibreringsprogrammet<\/li><li>M\u00f6jlighet att f\u00f6lja instruktioner ang\u00e5ende underh\u00e5ll och anv\u00e4ndning av utrustning<\/li><li>Samvetsgrann attityd<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Bekr\u00e4ftar \u00f6verensst\u00e4mmelse<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Granskning av kalibreringsprogrammet<\/li><li>Interna granskningar (kr\u00e4vs av QSR)<\/li><li>Uppr\u00e4tth\u00e5lla ett l\u00e4mpligt schema<\/li><li>Uppr\u00e4tth\u00e5lla korrekt dokumentation<\/li><li>L\u00e4mpligt underh\u00e5ll av standarder<\/li><li>Tillr\u00e4cklighet f\u00f6r avhj\u00e4lpande \u00e5tg\u00e4rder<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Externa granskningar<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>FDA anser att kontraktslaboratorierna \u00e4r en f\u00f6rl\u00e4ngning av en tillverkares GMP -program s\u00e5 att periodiska \u00e4r l\u00e4mpliga<\/li><li>Skaffa dokumentation som verifierar att utrustningen kalibrerades under kontrollerade f\u00f6rh\u00e5llanden med hj\u00e4lp av sp\u00e5rbara standarder<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Ytterligare oro<\/h4>\n\n\n\n<ul class=\"wp-block-list\"><li>Tillverkningsutrustning som anv\u00e4nds i produktionsprocessen (om den \u00e4r automatiserad) m\u00e5ste kalibreras periodiskt<\/li><li>Tillverkningsutrustning som \u00e4r datorstyrd m\u00e5ste valideras f\u00f6r avsedd anv\u00e4ndning och ing\u00e5 i ett kalibreringsprogram<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Till\u00e4gg till definitioner<\/h4>\n\n\n\n<p><strong>Installationskvalifikation (IQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fick du vad du ville?<\/li><li>Har du r\u00e4tt faciliteter f\u00f6r att anv\u00e4nda den?<\/li><li>\u00c4r all utrustning korrekt redovisad:<ul><li>Serienummer<\/li><li>Tillverkare<\/li><li>Internt tillg\u00e5ngsnummer<\/li><li>Korrekt installation<\/li><li>Instrumentloggbok p\u00e5 plats<\/li><li>Labplats<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Operationell kvalifikation (OQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Dokumentation som verifierar att laboratorieutrustningen fungerar \u00f6ver f\u00f6rv\u00e4ntade anv\u00e4ndningsomr\u00e5den<\/li><li>Serie av funktionstester f\u00f6r att s\u00e4kerst\u00e4lla att ett instrument\/system fungerar i enlighet med gr\u00e4nserna f\u00f6r en f\u00f6rutbest\u00e4md upps\u00e4ttning kriterier<\/li><\/ul>\n\n\n\n<p><strong>Prestationskvalifikation (PQ):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Indikerar att en specifik upps\u00e4ttning metodparametrar fungerar korrekt med avseende p\u00e5 den historiska metodvalideringen<\/li><li>I vissa fall kan systemets l\u00e4mplighet vara acceptabel som prestandakvalificering<br>Omkvalificering (RQ):<\/li><li>Best\u00e4mning av att ett instrument, efter reparation, leverant\u00f6rstj\u00e4nst, plats\u00e4ndring eller justeringar har gjorts fungerar som f\u00f6rv\u00e4ntat och avsett<\/li><li>\u00d6verv\u00e4ganden<ul><li>Uppfyller instrumentet originalprotokoll som uppr\u00e4ttats?<\/li><li>Om inte, vilka beslut beh\u00f6ver tas?<\/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. Typical<\/p>\n<p class=\"more-link\"><a href=\"https:\/\/www.agilelabs.co.za\/sv\/software-validation-testing\/\" class=\"themebutton\">L\u00e4s mer<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[],"tags":[],"class_list":["post-11820","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO Pro 4.7.0 - aioseo.com -->\n\t\t<meta name=\"description\" content=\"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. 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