{"id":5347,"date":"2021-09-23T22:35:23","date_gmt":"2021-09-23T19:35:23","guid":{"rendered":"https:\/\/medfilesgroup.com\/palvelut\/quality-assurance-services\/"},"modified":"2025-02-28T09:41:51","modified_gmt":"2025-02-28T07:41:51","slug":"laadunvarmistuspalvelut","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/fi\/palvelut\/laadunvarmistuspalvelut\/","title":{"rendered":"Laadunvarmistuspalvelut"},"content":{"rendered":"\n<figure class=\"wp-block-image alignfull size-full\"><img width=\"1920\" height=\"554\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa.jpg\" alt=\"Laadunvarmistuspalvelut\" class=\"wp-image-15971\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa.jpg 1920w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa-300x87.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa-1024x295.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa-768x222.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/01\/quality-assurance-services-qa-1536x443.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<div class=\"wp-block-group alignfull\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n\n\n\n<h1 class=\"wp-block-heading\">Laadunhallintaj\u00e4rjestelm\u00e4 ja laadunvarmistuspalvelut l\u00e4\u00e4kkeille, l\u00e4\u00e4kinn\u00e4llisille laitteille ja IVD-laitteille<\/h1>\n\n\n\n<p>Laadunhallinta on t\u00e4n\u00e4 p\u00e4iv\u00e4n\u00e4 ehdoton v\u00e4ltt\u00e4m\u00e4tt\u00f6myys l\u00e4\u00e4keyrityksille sek\u00e4 l\u00e4\u00e4kinn\u00e4llisten laitteiden ja IVD-laitteiden valmistajille. Viranomaiset valvovat laatustandardien noudattamista ja suorittavat s\u00e4\u00e4nn\u00f6llisesti tarkistuksia.<\/p>\n\n\n\n<p>Jos tarvitset konsultaatiota laadunhallintaj\u00e4rjestelmist\u00e4 tai laatuun liittyvist\u00e4 prosesseista, Medfilesin kokenut laadunvarmistustiimi auttaa sinua mielell\u00e4\u00e4n. Tiimill\u00e4mme on asiantuntemusta <a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/\">kliinisten l\u00e4\u00e4ketutkimusten<\/a> (GCP), <a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laaketurvapalvelut-ihmis-ja-elainlaakkeille\/\">l\u00e4\u00e4keturvatoiminnan<\/a> (GVP), l\u00e4\u00e4kkeiden hyvien tuotantotapojen (GMP) sek\u00e4 <a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laakinnalliset-laitteet-ja-ivd-laitteet\/\">l\u00e4\u00e4kinn\u00e4llisten laitteiden ja IVD-laitteiden<\/a> laadunvarmistuksesta ja laadunhallintaj\u00e4rjestelmist\u00e4. Lis\u00e4ksi tarjoamme GxP-koulutusta ja konsultointia sek\u00e4 tukea vakioitujen toimintaohjeiden (SOP) ja laatuohjeiden laatimiseen.<\/p>\n\n\n\n<p>Medfilesilla on asiantuntemusta my\u00f6s l\u00e4\u00e4kkeiden hyvist\u00e4 jakelutavoista (GDP) ja vahvaa l\u00e4\u00e4ketukkukaupan osaamista. Laillistetut proviisorimme voivat toimia Suomessa l\u00e4\u00e4ketukkukaupan vastuunalaisina johtajina, my\u00f6s lyhytkestoisesti.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"#contact-us\">kysy lis\u00e4tietoja tai tarjousta<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"http:\/\/shorturl.at\/gkpP9\" rel=\"noopener\">varaa tapaaminen<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:53px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-e61e4e29c928506ad1a4ef401ba23add\">Auditoinnit<\/h2>\n\n\n\n<p>Voimme tukea sinua GCP-, GDP- tai PV-auditoinneissa tarjoamalla auditointipalveluita sek\u00e4 konsultointia. Medfilesilla on talossa useita p\u00e4tevi\u00e4 GxP-auditoijia, jotka voivat toimia joko p\u00e4\u00e4auditoijana tai auttaa sinua asiantuntijana.<\/p>\n\n\n\n<p><strong>Kokeneet auditoijamme auttavat seuraavissa:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>tutkimuskeskusten ja alihankkijoiden auditoinnit<\/li>\n\n\n\n<li>CRA toiminnan auditoinnit<\/li>\n\n\n\n<li>l\u00e4\u00e4keturvatoiminnan auditoinnit<\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laakinnalliset-laitteet-ja-ivd-laitteet\/\">l\u00e4\u00e4kinn\u00e4llisten laitteiden laadunhallintaj\u00e4rjestelmien esiauditoinnit<\/a><\/li>\n<\/ul>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-9e7ae58fb27d76616282f15a7e7e56e1\">Laatu Medfilesilla<\/h2>\n\n\n\n<p>Koko Medfilesin henkil\u00f6kunta on sitoutunut laatustandardien noudattamiseen. Olemme aina ajan tasalla GxP-vaatimuksista ja tietoisia tulevista muutoksista. Olemme ylpeit\u00e4 voidessamme tarjota asiakkaillemme parasta mahdollista laatua.<\/p>\n\n\n\n<p>Korkean laatutason varmistamiseksi j\u00e4rjest\u00e4mme henkil\u00f6st\u00f6llemme s\u00e4\u00e4nn\u00f6llisi\u00e4 GxP-koulutuksia (mukaan lukien GVP, GCP, GDP) heid\u00e4n ty\u00f6teht\u00e4viins\u00e4 liittyen.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-5fb5ffaf337b1ae08cb8ac8fdc16fc93\">Laadunhallintaj\u00e4rjestelm\u00e4<\/h2>\n\n\n\n<p>Kaikkien liiketoimintayksik\u00f6idemme toiminta perustuu vakioituihin toimintamenettelyihin eli SOP-j\u00e4rjestelm\u00e4\u00e4n ja yrityksen politiikkoihin. Medfilesin laatuj\u00e4rjestelm\u00e4\u00e4 yll\u00e4pidet\u00e4\u00e4n, kehitet\u00e4\u00e4n ja p\u00e4ivitet\u00e4\u00e4n GxP-ohjeiden ja soveltuvien viranomaisvaatimusten mukaisesti.<\/p>\n\n\n\n<p>K\u00e4yt\u00f6ss\u00e4mme on validoitu laadunhallintaj\u00e4rjestelm\u00e4 (eQMS), joka sis\u00e4lt\u00e4\u00e4 SOP:t, poikkeamien ja valitusten k\u00e4sittelyn sek\u00e4 muutosten hallinnan. Yhten\u00e4inen laatuj\u00e4rjestelm\u00e4mme varmistaa, ett\u00e4 laatuty\u00f6 ulottuu kaikkeen toimintaamme. N\u00e4in my\u00f6s muut kuin GxP-toiminnot kuuluvat laatustandardij\u00e4rjestelm\u00e4n piiriin.<\/p>\n\n\n\n<p>Laatuj\u00e4rjestelm\u00e4mme ja -toimintamme auditoidaan s\u00e4\u00e4nn\u00f6llisesti viranomaisten ja asiakkaidemme toimesta.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-66d5aa11d9032fb694a20817c39320e4\">Laadunvarmistustiimi (QA-tiimi)<\/h2>\n\n\n\n<p>Laadunvarmistustiimimme huolehtii laatuj\u00e4rjestelm\u00e4st\u00e4mme ja tekev\u00e4t yhteisty\u00f6t\u00e4 yksik\u00f6iden asiantuntijoiden kanssa varmistaakseen laadukkaan ty\u00f6n asiakkaillemme.<\/p>\n\n\n\n<p>Laatujohtajamme ja laadunvarmistusp\u00e4\u00e4llikk\u00f6mme, joilla on vuosikymmenten GxP-kokemus, varmistavat, ett\u00e4 vaatimukset t\u00e4yttyv\u00e4t.<\/p>\n\n\n\n<p>Jokaiselle GxP-alueelle on nimetty laadunvarmistusp\u00e4\u00e4llikk\u00f6. N\u00e4in varmistamme, ett\u00e4 GxP-vaatimusten valvonta pysyy asiantuntijan k\u00e4siss\u00e4. Lis\u00e4ksi laadunvarmistuskoordinaattorimme ja -assistenttimme huolehtivat p\u00e4ivitt\u00e4isist\u00e4 toiminnoista.<\/p>\n\n\n\n<div class=\"wp-block-group has-white-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-wide\" style=\"background-color:#ecececc2;color:#ecececc2\"\/>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" id=\"contact-us\">Kerron mielell\u00e4ni lis\u00e4\u00e4<\/h2>\n\n\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:200px\"><div class=\"wp-block-image is-style-default\">\n<figure class=\"alignleft size-full\"><img width=\"600\" height=\"900\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi.jpg\" alt=\"Mervi Reini\" class=\"wp-image-13749\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi.jpg 600w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi-200x300.jpg 200w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:360px\">\n<p class=\"has-text-align-left\"><strong>Mervi Reini<\/strong><br>Marketing Manager<br>+358 20 744 1502<br><a href=\"mailto:mervi.reini@medfiles.eu\">mervi.reini@medfiles.eu<\/a><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-default\" style=\"background-color:#ecececc2;color:#ecececc2\"\/>\n<\/div><\/div>\n\n\n<div class=\"gb-container gb-container-f003b260\"><div class=\"gb-inside-container\">\n\n<div style=\"height:0px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-be00b838\">\n<div class=\"gb-grid-column gb-grid-column-453c546f\"><div class=\"gb-container gb-container-453c546f contact-us\"><div class=\"gb-inside-container\">\n<script>\nvar 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value='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' \/>\n            <input type='hidden' autocomplete='off' class='gform_hidden' name='gform_target_page_number_5' id='gform_target_page_number_5' value='0' \/>\n            <input type='hidden' autocomplete='off' class='gform_hidden' name='gform_source_page_number_5' id='gform_source_page_number_5' value='1' \/>\n            <input type='hidden' name='gform_field_values' value='' \/>\n            \n        <\/div>\n                        <\/form>\n                        <\/div>\n<\/div><\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-41ade907\"><div class=\"gb-container gb-container-41ade907 news-and-events\"><div class=\"gb-inside-container\">\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:28px\">Sinua voisi kiinnostaa: <\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/\">Kliiniset tutkimuspalvelut<\/a><a href=\"https:\/\/medfilesgroup.com\/services\/clinical-services\/\"> <\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laaketurvapalvelut-ihmis-ja-elainlaakkeille\/\">L\u00e4\u00e4keturvapalvelut<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laakinnalliset-laitteet-ja-ivd-laitteet\/\">Palvelut l\u00e4\u00e4kinn\u00e4llisille laitteille ja IVD-laitteille<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/yhteystiedot\/tilaa-medfilesin-uutiskirje\/\">Tilaa Medfilesin uutiskirje<\/a><\/div>\n<\/div>\n\n<\/div><\/div><\/div>\n<\/div>\n<\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Laadunhallintaj\u00e4rjestelm\u00e4 ja laadunvarmistuspalvelut l\u00e4\u00e4kkeille, l\u00e4\u00e4kinn\u00e4llisille laitteille ja IVD-laitteille Laadunhallinta on t\u00e4n\u00e4 p\u00e4iv\u00e4n\u00e4 ehdoton v\u00e4ltt\u00e4m\u00e4tt\u00f6myys l\u00e4\u00e4keyrityksille sek\u00e4 l\u00e4\u00e4kinn\u00e4llisten laitteiden ja IVD-laitteiden valmistajille. Viranomaiset valvovat laatustandardien noudattamista &#8230; <a title=\"Laadunvarmistuspalvelut\" class=\"read-more\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laadunvarmistuspalvelut\/\" aria-label=\"Lis\u00e4\u00e4 Laadunvarmistuspalvelut\">Lue lis\u00e4\u00e4<\/a><\/p>\n","protected":false},"author":1,"featured_media":15971,"parent":181,"menu_order":68,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5347","page","type-page","status-publish","has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/5347","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/comments?post=5347"}],"version-history":[{"count":18,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/5347\/revisions"}],"predecessor-version":[{"id":18715,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/5347\/revisions\/18715"}],"up":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/181"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/media\/15971"}],"wp:attachment":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/media?parent=5347"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}