{"id":1471,"date":"2025-11-19T16:06:15","date_gmt":"2025-11-19T16:06:15","guid":{"rendered":"https:\/\/sallyq.se\/?p=1471"},"modified":"2025-11-19T16:06:16","modified_gmt":"2025-11-19T16:06:16","slug":"jokern-i-annex-11-draften-frihet-under-ansvar","status":"publish","type":"post","link":"https:\/\/sallyq.se\/en\/jokern-i-annex-11-draften-frihet-under-ansvar\/","title":{"rendered":"Jokern i Annex 11 draften \u2013 frihet under ansvar?"},"content":{"rendered":"<p>N\u00e4r Jenny och Jonas <a href=\"https:\/\/sallyq.se\/en\/behover-du-oroa-dig-for-uppdateringen-av-annex-11-computerised-systems\/\">djupdykte i draften av Annex 11<\/a> fastnade b\u00e5da vid en formulering som sticker ut:<br><strong>punkt 2.3 \u2013 \u201cAlternative Practices\u201d.<\/strong><br>\u201c<em>Practices which constitute alternatives to the activities required in this document may be used, if they have been proven and documented to provide the same or higher level of control<\/em>.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Vad betyder det h\u00e4r?<\/h2>\n\n\n\n<p>Kort sagt: <strong>myndigheterna \u00f6ppnar f\u00f6r alternativa s\u00e4tt att uppn\u00e5 kontroll \u2013 s\u00e5 l\u00e4nge du kan bevisa att de fungerar minst lika bra.<\/strong><br>Det kan uppfattas som en joker i leken, men just d\u00e4rf\u00f6r kr\u00e4ver den b\u00e5de fingertoppsk\u00e4nsla och mod att anv\u00e4nda p\u00e5 r\u00e4tt s\u00e4tt. Vad t\u00e4nker ni?<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p><strong> Jenny:<\/strong><br>\u201cDet h\u00e4r \u00e4r egentligen en fantastisk m\u00f6jlighet. Det inneb\u00e4r att f\u00f6retag med digitala arbetss\u00e4tt och verktyg \u2013 till exempel automatiserade testmilj\u00f6er, molnplattformar eller AI-st\u00f6d \u2013 faktiskt kan anv\u00e4nda dessa, om man kan visa att kvalitetsniv\u00e5n bibeh\u00e5lls.\u201d<\/p>\n\n\n\n<p><strong>Jonas:<\/strong><br>\u201cPrecis. Men det inneb\u00e4r ocks\u00e5 ett ansvar. Bevisb\u00f6rdan ligger p\u00e5 f\u00f6retaget \u2013 inte p\u00e5 inspekt\u00f6ren. Du m\u00e5ste kunna visa att din metod ger samma eller h\u00f6gre niv\u00e5 av kontroll \u00e4n det som st\u00e5r i Annexet. Det kr\u00e4ver b\u00e5de dokumentation och riskmedvetenhet. En annan f\u00f6rdel \u00e4r att paragrafen \u00f6ppnar f\u00f6r kommande tekniska l\u00f6sningar \u2013 s\u00e5dant som branschen inte ens anv\u00e4nder idag, men som kan komma att bli praxis i framtiden. Det g\u00f6r regelverket mer framtidss\u00e4krat och samtidigt \u00f6ppet f\u00f6r innovation, utan att binda fast oss vid dagens l\u00f6sningar.\u201d<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1025\" src=\"https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited.png\" alt=\"\" class=\"wp-image-1410\" style=\"width:245px;height:auto\" srcset=\"https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited.png 1024w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited-300x300.png 300w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited-150x150.png 150w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited-768x769.png 768w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/10\/ChatGPT-Image-28-okt.-2025-16_03_13-edited-12x12.png 12w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\">Jenny och Jonas med jokern i Annex 11 draft &#8211; eller \u00e4r det en joker?<\/figcaption><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Frihet, men ingen frisedel<\/strong><\/h3>\n\n\n\n<p>\u201cAlternative Practices\u201d kan bli en v\u00e4lkommen ventil f\u00f6r organisationer som jobbar mer agilt, men det \u00e4r ingen genv\u00e4g. Tv\u00e4rtom kan den kr\u00e4va \u00e4nnu tydligare rationaler, riskbed\u00f6mningar och valideringsargumentation.<\/p>\n\n\n\n<p>F\u00f6r m\u00e5nga f\u00f6retag kan just denna paragraf bli det som avg\u00f6r hur v\u00e4l de lyckas balansera innovation med implementering av nya digitala verktyg och compliance \u2013 och det kommer kr\u00e4va b\u00e5de mod och kompetens att anv\u00e4nda den klokt. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Varf\u00f6r f\u00e5 kommer spela jokern \u2013 \u00e5tminstone i b\u00f6rjan<\/h3>\n\n\n\n<p>Vi tror dock inte att s\u00e5 m\u00e5nga f\u00f6retag initialt kommer anv\u00e4nda sig av Jokern  \u201dAlternative practice\u201d. <br>Varf\u00f6r? D\u00e4rf\u00f6r att:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>De flesta organisationer lutar sig mot etablerade kvalitetssystem f\u00f6r att uppfylla kraven i regelverk<\/li>\n\n\n\n<li>SOP:ar \u00e4r skrivna f\u00f6r att beskriva hur krav uppfylls, inte f\u00f6r att fr\u00e4mja alternativ<\/li>\n\n\n\n<li>Kultur \u201ds\u00e5 h\u00e4r har vi alltid gjort\u201d kan finnas<\/li>\n\n\n\n<li>F\u00e5 vill vara den som g\u00e5r f\u00f6rst och testar myndigheternas gr\u00e4nser<\/li>\n<\/ul>\n\n\n\n<p>Med andra ord: m\u00e5nga v\u00e4ntar g\u00e4rna p\u00e5 att \u201dn\u00e5gon annan\u201d visar vad inspekt\u00f6rerna faktiskt accepterar \u2013 innan man sj\u00e4lv v\u00e5gar prova.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\ud83e\udded Slutsats: en chans att h\u00f6ja niv\u00e5n<\/strong><\/h3>\n\n\n\n<p>Den nya versionen av Annex 11 handlar i grunden inte om att g\u00f6ra det sv\u00e5rare \u2013 utan om att <strong>h\u00f6ja medvetenheten och kvaliteten<\/strong> i hur vi hanterar digitala system i GxP-milj\u00f6.<\/p>\n\n\n\n<p>\u201cJokern\u201d i punkt 2.3 ger oss m\u00f6jligheten att visa mognad \u2013 att g\u00e5 fr\u00e5n regelstyrd efterlevnad till riskbaserad f\u00f6rst\u00e5else.<br>Men precis som i alla kortspel g\u00e4ller det att veta <em>n\u00e4r<\/em> &#8211; och <em>hur<\/em> &#8211; man spelar den.<br><\/p>\n\n\n\n<p>Kommer din organisation kunna vara \u201dn\u00e5gon annan\u201d och anv\u00e4nda sig av \u201cAlternative Practices\u201d n\u00e4r Annex 11 \u00e4r uppdaterad?<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\ud83d\udca1 Vill du veta mer?<\/strong><\/h2>\n\n\n\n<p>SallyQ f\u00f6ljer utvecklingen av Annex 11 och dess praktiska konsekvenser f\u00f6r QA, IT och validering.<br>H\u00f6r g\u00e4rna av dig om du vill diskutera hur du kan f\u00f6rbereda din organisation inf\u00f6r implementeringen \u2013 kanske f\u00f6r att kunna g\u00e5 f\u00f6rst och vara &#8221;n\u00e5gon annan&#8221;<\/p>\n\n\n\n<p>&nbsp;\ud83d\udc49 Kontakta oss h\u00e4r <a href=\"https:\/\/sallyq.se\/en\/kontakt-2\/\">Contact<\/a><\/p>\n\n\n<\/ul>\n<p><!-- \/wp:post-content --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>&nbsp;<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>&nbsp;<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n\n<!-- wp:paragraph -->\n<p><\/p>\n<!-- \/wp:paragraph -->","protected":false},"excerpt":{"rendered":"<p>N\u00e4r Jenny och Jonas d\u00f6k ner i Annex 11-draften hittade de en joker som kan f\u00f6r\u00e4ndra spelplanen. Vad inneb\u00e4r \u201dAlternative Practices\u201d \u2013 och n\u00e4r b\u00f6r man spela den?<\/p>","protected":false},"author":1,"featured_media":1487,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","_kad_post_transparent":"default","_kad_post_title":"default","_kad_post_layout":"default","_kad_post_sidebar_id":"","_kad_post_content_style":"default","_kad_post_vertical_padding":"default","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[5],"tags":[11,12,13,7],"class_list":["post-1471","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kvaltet","tag-annex11","tag-csv","tag-datoriserade-system","tag-life-science"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Jokern i Annex 11 draften \u2013 frihet under ansvar? - SallyQ %<\/title>\n<meta name=\"description\" content=\"N\u00e4r Jenny och Jonas d\u00f6k ner i Annex 11-draften hittade de en joker som kan f\u00f6r\u00e4ndra spelplanen. 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