{"id":1503,"date":"2025-12-10T12:00:22","date_gmt":"2025-12-10T12:00:22","guid":{"rendered":"https:\/\/sallyq.se\/?p=1503"},"modified":"2026-01-12T08:40:23","modified_gmt":"2026-01-12T08:40:23","slug":"systemlivscykeln-och-myndigheternas-skarpta-forvantningar","status":"publish","type":"post","link":"https:\/\/sallyq.se\/en\/systemlivscykeln-och-myndigheternas-skarpta-forvantningar\/","title":{"rendered":"Systemets livscykel \u2013 och myndigheternas sk\u00e4rpta f\u00f6rv\u00e4ntningar"},"content":{"rendered":"<p>Datoriserade system anv\u00e4nds idag i n\u00e4stan alla delar av GxP-verksamheten. De \u00e4r avg\u00f6rande f\u00f6r: produktion, kvalitet, analys, dokumentation, sp\u00e5rbarhet och beslutsfattande.<br>Inledningsvis myndigheterna \u2013 EMA, FDA och andra globala regulatorer \u2013 har p\u00e5 senare \u00e5r blivit betydligt tydligare med vad de f\u00f6rv\u00e4ntar sig. Kraven har inte bara \u00f6kat i omfattning, utan ocks\u00e5 i detaljniv\u00e5.<\/p>\n\n\n\n<p>Det centrala budskapet \u00e4r gemensamt i alla guidelines:<br>\u27a1\ufe0f <strong>Systemets livscykel ska vara vara en integrerad och aktiv del av f\u00f6retagets kvalitetsledningssystem (QMS).<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Har f\u00f6rv\u00e4ntningarna \u00f6kat? <\/strong><\/h2>\n\n\n\n<p>De senaste \u00e5rens uppdatering av regulatoriska- och guidelines-dokument visar framf\u00f6r allt tre klara trender och en bubblare:<\/p>\n\n\n\n<p><strong>1. \u00d6kad fokus p\u00e5 dataintegritet och sp\u00e5rbarhet<\/strong><\/p>\n\n\n\n<p>Inspektioner fokuserar nu p\u00e5 hur organisationer kontrollerar sina system \u2013 inte bara p\u00e5 om systemen var validerade vid go-live.<br>Granskning av Audit trail, rollstyrning, \u00f6vervakning och \u00e4ndringshantering har s\u00e5ledes blivit betydligt h\u00e5rdare \u00e4n f\u00f6r 5\u201310 \u00e5r sedan.<\/p>\n\n\n\n<p><strong>2. Livscykelstyrning, inte punktinsatser<\/strong><\/p>\n\n\n\n<p>GAMP 5 (2nd Edition) och draft Annex 11 betonar livscykeln som ett helhetskoncept d\u00e4r &#8221;hela resan&#8221; m\u00e5ste vara dokumenterad och riskbaserad:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>planering<\/li>\n\n\n\n<li>anskaffning<\/li>\n\n\n\n<li>inf\u00f6rande<\/li>\n\n\n\n<li>drift och f\u00f6r\u00e4ndring<\/li>\n\n\n\n<li>avveckling<\/li>\n<\/ul>\n\n\n\n<p>Validering beh\u00f6ver allts\u00e5 g\u00e5 fr\u00e5n \u201dtestning av ett system\u201d till <strong>kontinuerlig livscykelvalidering<\/strong>.<\/p>\n\n\n\n<p><strong>3. St\u00f6rre ansvar f\u00f6r leverant\u00f6rer och molntj\u00e4nster<\/strong><\/p>\n\n\n\n<p>Annex 11 och FDA \u00e4r tydliga:<br>Den som anv\u00e4nder systemet har alltid det regulatoriska ansvaret, \u00e4ven n\u00e4r en molnleverant\u00f6r levererar det.<\/p>\n\n\n\n<p>Leverant\u00f6rsbed\u00f6mning, Service level agreement (SLA:er), dataskydd och modelltransparens (f\u00f6r algoritm eller AI-modell) \u00e4r nu sj\u00e4lvklara inspektionspunkter.<\/p>\n\n\n\n<p><strong>Bubblare: AI-system driver ytterligare f\u00f6rv\u00e4ntningar<\/strong><\/p>\n\n\n\n<p>EMA:s nya Annex 22 <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdfhttps:\/\/health.ec.europa.eu\/document\/download\/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf\">Artificial Intelligence<\/a> (draft) och FDA:s <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligencehttps:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence\">PCCP-guidance<\/a> f\u00f6r Medical device (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions) \u00e4r en viktig mark\u00f6r:<br>Myndigheter f\u00f6rv\u00e4ntar sig att organisationer styr \u00e4ven AI-system genom hela livscykeln \u2013 med f\u00f6rdefinierade gr\u00e4nser, m\u00e4tbara kriterier och tydligt ansvar f\u00f6r framtida \u00e4ndringar.<\/p>\n\n\n\n<p>\u27a1\ufe0f Detta driver ocks\u00e5 upp f\u00f6rv\u00e4ntningarna p\u00e5 traditionella IT-system: kontroller ska vara robusta, sp\u00e5rbara och datadrivna.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Vad s\u00e4ger myndigheterna?<\/strong><\/h2>\n\n\n\n<p>Nedan f\u00f6ljer en sammanst\u00e4llning av centrala regulatoriska krav r\u00f6rande systemlivscykel:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>GAMP 5 (2nd Edition) \u2013 branschstandarden f\u00f6r livscykelarbete<\/strong><\/h3>\n\n\n\n<p><strong>GAMP 5 \u00e4r tydlig:<\/strong><br>Datoriserade system ska styras genom hela sin livscykel med en <strong>riskbaserad strategi<\/strong>.<br>Nytt i 2nd Edition \u00e4r ett \u00e4nnu st\u00f6rre fokus p\u00e5:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Proportionalitet och skalbarhet<\/li>\n\n\n\n<li>Dataintegritet och governance (Governance = strukturerad styrning och ansvar f\u00f6r system och processer \u2013 fr\u00e5n strategi till drift och f\u00f6rb\u00e4ttring. Det handlar s\u00e5ledes inte bara om att ha en process, utan om hur processen kontrolleras, \u00e4gs, efterlevs och f\u00f6rb\u00e4ttras).<\/li>\n\n\n\n<li>Molnbaserade l\u00f6sningar och delat ansvar<\/li>\n\n\n\n<li>Kontinuerlig \u00f6vervakning och f\u00f6rb\u00e4ttring<\/li>\n\n\n\n<li>AI\/ML och adaptiva system<\/li>\n<\/ul>\n\n\n\n<p>Sammanfattningsvis livscykeln \u00e4r inte n\u00e5got man \u201dg\u00f6r en g\u00e5ng\u201d \u2013 den \u00e4r en del av f\u00f6retagets dagliga QMS.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"619\" height=\"531\" src=\"https:\/\/sallyq.se\/wp-content\/uploads\/2025\/12\/Skarmbild-2025-12-08-181048.png\" alt=\"\" class=\"wp-image-1505\" srcset=\"https:\/\/sallyq.se\/wp-content\/uploads\/2025\/12\/Skarmbild-2025-12-08-181048.png 619w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/12\/Skarmbild-2025-12-08-181048-300x257.png 300w, https:\/\/sallyq.se\/wp-content\/uploads\/2025\/12\/Skarmbild-2025-12-08-181048-14x12.png 14w\" sizes=\"auto, (max-width: 619px) 100vw, 619px\" \/><figcaption class=\"wp-element-caption\">Systemlivscykeln kan best\u00e5 av fyra faser \u2013 strategi, inf\u00f6rande, drift och avveckling \u2013 som tillsammans s\u00e4kerst\u00e4ller kontroll, efterlevnad och l\u00e5ngsiktig h\u00e5llbarhet.<\/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><strong>EU Annex 11 draft \u2013 krav p\u00e5 kontroll, ansvar och dokumentation<\/strong><\/strong><\/h3>\n\n\n\n<p><a href=\"https:\/\/health.ec.europa.eu\/publications\/draft-annex-11-computerised-systems_en\">Annex 11 draft<\/a> st\u00e4ller ytterligare krav p\u00e5:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>dokumentation genom hela livscykeln<\/li>\n\n\n\n<li>riskbed\u00f6mningar f\u00f6r b\u00e5de system och processer<\/li>\n\n\n\n<li>\u00e4ndringshantering<\/li>\n\n\n\n<li>leverant\u00f6rsbed\u00f6mning<\/li>\n\n\n\n<li>s\u00e4ker drift, audit trail och \u00e5tkomstkontroll<\/li>\n\n\n\n<li>avveckling och arkivering<\/li>\n<\/ul>\n\n\n\n<p>Annex 11 pekar ocks\u00e5 ut att <strong>organisationen aldrig f\u00e5r f\u00f6rlora kontrollen \u00f6ver sitt system<\/strong>, \u00e4ven n\u00e4r det \u00e4r externt utvecklat eller molnbaserat.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>FDA \u2013 Part 11, CSA och PCCP<\/strong><\/h3>\n\n\n\n<p>FDA fokuserar huvudsakligen p\u00e5 tre centrala teman:<\/p>\n\n\n\n<p><strong>1. Part 11<\/strong><br>Elektroniska data och signaturer m\u00e5ste vara:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>sp\u00e5rbara<\/li>\n\n\n\n<li>korrekta<\/li>\n\n\n\n<li>skyddade<\/li>\n\n\n\n<li>granskningsbara<\/li>\n<\/ul>\n\n\n\n<p><strong>2. CSA (Computer Software Assurance)<\/strong><br>FDA uppmuntrar riskbaserad validering men f\u00f6rv\u00e4ntar sig samtidigt <strong>tydlig styrning, dokumentation och verifierbara kontroller<\/strong>.<\/p>\n\n\n\n<p><strong>3.<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence\"> PCCP f\u00f6r AI\/ML-system<\/a><\/strong> Medical device<br>FDA:s -guidance &#8221;<em>Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Guidance for Industry and Food and Drug Administration Staff (August 2025)<\/em>&#8221; g\u00e4ller f\u00f6r Medical device men kan antas bli motsvarande f\u00f6r l\u00e4kemedel d\u00e5 likheter finns i EMAs <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdfhttps:\/\/health.ec.europa.eu\/document\/download\/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf\">draft av Annex 22<\/a>: Artificial Intelligence (nytt annex).<\/p>\n\n\n\n<p>FDA:s -guidance beskriver s\u00e4rskilt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>hur framtida \u00e4ndringar ska styras<\/li>\n\n\n\n<li>vilka modeller som f\u00e5r uppdateras<\/li>\n\n\n\n<li>vilka parametrar som \u00e4r kritiska<\/li>\n\n\n\n<li>hur prestanda ska \u00f6vervakas och verifieras<\/li>\n\n\n\n<li>vilka guardrails<sup>*<\/sup> som m\u00e5ste vara p\u00e5 plats<\/li>\n\n\n\n<li>hur versioner och tr\u00e4ningsdata ska sp\u00e5ras<\/li>\n<\/ul>\n\n\n\n<p>Sammantaget \u00e4r detta tydligt h\u00f6gre krav \u00e4n f\u00f6r traditionell mjukvara \u2013 och speglar en generell regulatorisk r\u00f6relse mot <strong>starkare livscykelkontroll<\/strong>.<\/p>\n\n\n\n<p>* <strong>Guardrails<\/strong> \u00e4r de \u201dskyddsr\u00e4cken\u201d som h\u00e5ller ett system eller en modell inom s\u00e4kra och regulatoriskt kontrollerade gr\u00e4nser.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>definierar vad som <em>f\u00e5r<\/em> \u00e4ndras<\/li>\n\n\n\n<li>stoppar det som <em>inte f\u00e5r<\/em> \u00e4ndras<\/li>\n\n\n\n<li>s\u00e4kerst\u00e4ller att \u00e4ndringar forts\u00e4tter vara validerade<\/li>\n\n\n\n<li>\u00e4r centrala i b\u00e5de GAMP 5 och FDA:s PCCP-t\u00e4nk<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>\ud83e\udded <strong>Sammanfattning: Myndigheterna f\u00f6rv\u00e4ntar sig mer \u2013 och tydligare \u2013 livscykelhantering \u00e4n n\u00e5gonsin<\/strong><\/strong><\/h3>\n\n\n\n<p>Internationella myndigheter och standardiseringsorgan \u00e4r f\u00f6ljaktligen helt eniga:<br><strong>F\u00f6retag m\u00e5ste visa kontroll, ansvar och sp\u00e5rbarhet genom hela systemets livscykel.<\/strong><\/p>\n\n\n\n<p>Allt som allt \u2013 <strong>f\u00f6rv\u00e4ntningarna har \u00f6kat<\/strong>.<br>Drivkrafterna \u00e4r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00f6kade datam\u00e4ngder<\/li>\n\n\n\n<li>fler integrerade och molnbaserade system<\/li>\n\n\n\n<li>h\u00f6gre regulatoriskt fokus p\u00e5 dataintegritet<\/li>\n\n\n\n<li>st\u00f6rre beroende av digitala processer<\/li>\n\n\n\n<li>utvecklingen av AI-baserade system<\/li>\n<\/ul>\n\n\n\n<p>Mot den bakgrunden s\u00e5 \u00e4r systemets livscykel inte l\u00e4ngre ett \u201dbra att ha\u201d \u2013 den \u00e4r en f\u00f6ruts\u00e4ttning f\u00f6r compliance, robust verksamhet och patients\u00e4kerhet.<\/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 <strong>SallyQ \u2013 vi g\u00f6r det enkelt att g\u00f6ra r\u00e4tt<\/strong><\/strong><\/h2>\n\n\n\n<p>Vi st\u00f6ttar f\u00f6retag genom alla delar av systemlivscykeln: <\/p>\n\n\n<style>.wp-block-kadence-iconlist.kt-svg-icon-list-items1503_f68bb0-98:not(.this-stops-third-party-issues){margin-top:0px;margin-bottom:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1503_f68bb0-98 ul.kt-svg-icon-list:not(.this-prevents-issues):not(.this-stops-third-party-issues):not(.tijsloc){margin-top:0px;margin-right:0px;margin-bottom:var(--global-kb-spacing-sm, 1.5rem);margin-left:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1503_f68bb0-98 ul.kt-svg-icon-list{grid-row-gap:5px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items1503_f68bb0-98 ul.kt-svg-icon-list .kt-svg-icon-list-item-wrap .kt-svg-icon-list-single{margin-right:10px;}.kt-svg-icon-list-items1503_f68bb0-98 ul.kt-svg-icon-list .kt-svg-icon-list-level-0 .kt-svg-icon-list-single svg{font-size:20px;}<\/style>\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items1503_f68bb0-98 kt-svg-icon-list-columns-1 alignnone\"><ul class=\"kt-svg-icon-list\"><style>.kt-svg-icon-list-item-1503_51f82e-47 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1503_51f82e-47\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewbox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">strategi &amp; planering<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1503_7de92a-99 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1503_7de92a-99\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewbox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">inf\u00f6rande &amp; kvalificering<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1503_d94da8-69 .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1503_d94da8-69\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewbox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">f\u00f6rvaltning &amp; \u00e4ndringshantering<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-1503_14de07-fb .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-1503_14de07-fb\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_checkCircle kt-svg-icon-list-single\"><svg viewbox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><path d=\"M22 11.08V12a10 10 0 1 1-5.93-9.14\"\/><polyline points=\"22 4 12 14.01 9 11.01\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">avveckling<\/span><\/li>\n<\/ul><\/div>\n\n\n\n<p>Oavsett om det g\u00e4ller ett lokalt labbsystem, ett globalt molnsystem eller ett AI-drivet beslutsst\u00f6d. Vill du veta hur vi kan st\u00e4rka era system och ert QMS?<\/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\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\"><style>.kadence-column1503_ab9094-20 > .kt-inside-inner-col,.kadence-column1503_ab9094-20 > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column1503_ab9094-20 > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column1503_ab9094-20 > .kt-inside-inner-col{flex-direction:column;}.kadence-column1503_ab9094-20 > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column1503_ab9094-20 > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column1503_ab9094-20{position:relative;}@media all and (max-width: 1024px){.kadence-column1503_ab9094-20 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column1503_ab9094-20 > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column1503_ab9094-20\"><div class=\"kt-inside-inner-col\"><\/div><\/div>\n<\/div>\n\n\n\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\"><\/div>\n<\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Har ni n\u00e5gra system?<br \/>\n\u00c4r svaret Ja, s\u00e5 l\u00e4s vidare.<br \/>\nS\u00e5 m\u00f6ter du \u00f6kade krav p\u00e5 systemets livscykel fr\u00e5n GAMP 5, EU Annex 11 och FDA. S\u00e4kerst\u00e4ll dataintegritet, sp\u00e5rbarhet och kontroll i alla system.<\/p>","protected":false},"author":1,"featured_media":49,"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":[11,12,13,15,14,7,16,17],"class_list":["post-1503","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kvaltet","tag-annex11","tag-csv","tag-datoriserade-system","tag-fda","tag-gamp5","tag-life-science","tag-lifecycle","tag-livscykel"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Systemets livscykel \u2013 och myndigheternas sk\u00e4rpta f\u00f6rv\u00e4ntningar - SallyQ %<\/title>\n<meta name=\"description\" content=\"Har ni n\u00e5gra system? 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