{"id":831,"date":"2026-06-18T16:38:44","date_gmt":"2026-06-18T14:38:44","guid":{"rendered":"https:\/\/www.qvalitek.com\/?page_id=831"},"modified":"2026-06-18T16:57:02","modified_gmt":"2026-06-18T14:57:02","slug":"digital-quality-and-ai-compliance","status":"publish","type":"page","link":"https:\/\/www.qvalitek.com\/lt\/digital-quality-and-ai-compliance\/","title":{"rendered":"Skaitmenin\u0117 kokyb\u0117 ir AI atitiktis"},"content":{"rendered":"<div class=\"wp-block-cover\"><img data-dominant-color=\"44443d\" data-has-transparency=\"false\" style=\"--dominant-color: #44443d;\" decoding=\"async\" width=\"1024\" height=\"576\" sizes=\"(max-width: 1024px) 100vw, 1024px\" class=\"wp-block-cover__image-background wp-image-833 size-large not-transparent\" alt=\"\" src=\"https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-1024x576.jpg\" data-object-fit=\"cover\" srcset=\"https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-1024x576.jpg 1024w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-600x338.jpg 600w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-300x169.jpg 300w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-768x432.jpg 768w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-1536x864.jpg 1536w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash-18x10.jpg 18w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2026\/06\/zach-m-7F9PhBM1gFM-unsplash.jpg 1920w\" \/><span aria-hidden=\"true\" class=\"wp-block-cover__background has-black-background-color has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<p class=\"has-text-align-center has-white-color has-text-color has-link-color has-large-font-size wp-elements-1 wp-block-paragraph\">Dirbtinis intelektas, debesijos sistemos, automatizavimas ir skaitmenin\u0117s kokyb\u0117s platformos vis da\u017eniau naudojamos kokyb\u0117s, gamybos, laboratorij\u0173, dokumentacijos ir duomen\u0173 valdymo procesuose.<\/p>\n<\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Reguliuojamoms \u012fmon\u0117ms svarbu ne tik i\u0161bandyti naujas technologijas, bet ir u\u017etikrinti, kad j\u0173 naudojimas b\u016bt\u0173 kontroliuojamas, dokumentuotas, audituojamas ir suderintas su GxP, GMP, CSV, CSA bei duomen\u0173 vientisumo principais.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Qvalitek padeda \u012fmon\u0117ms pasiruo\u0161ti saugiam AI ir skaitmenini\u0173 kokyb\u0117s sistem\u0173 naudojimui: \u012fvertiname rizikas, parengiame governance dokumentus, SOP, tiek\u0117j\u0173 vertinimo klausimynus, mokym\u0173 programas ir validacijos strategij\u0105.<\/p>\n\n\n\n<div id=\"wp-block-themeisle-blocks-accordion-c9818ff1\" class=\"wp-block-themeisle-blocks-accordion exclusive\">\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>Kam skirta?<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\">\u0160ios paslaugos skirtos \u012fmon\u0117ms, kurios:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>svarsto ChatGPT, Copilot, Gemini, DeepL ar kit\u0173 AI \u012franki\u0173 naudojim\u0105 darbo procesuose;<\/li>\n\n\n\n<li>planuoja diegti eQMS, LIMS, MES, ERP, DMS ar kitas sistemas su AI funkcijomis;<\/li>\n\n\n\n<li>nori \u012fsivertinti, kur AI naudojimas gali paveikti GxP procesus;<\/li>\n\n\n\n<li>mato darbuotoj\u0173 neformal\u0173 AI naudojim\u0105 ir nori j\u012f suvaldyti;<\/li>\n\n\n\n<li>nori parengti AI naudojimo politik\u0105, SOP ir rizikos vertinimo \u0161ablonus;<\/li>\n\n\n\n<li>ruo\u0161iasi auditams, klient\u0173 klausimynams arba reguliaciniams poky\u010diams;<\/li>\n\n\n\n<li>nori pereiti nuo tradicin\u0117s CSV prie rizika gr\u012fstos CSA logikos.<\/li>\n<\/ul>\n<\/div><\/details>\n\n\n\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>Paslaugos<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\"><strong>AI naudojimo atvej\u0173 ir GxP rizikos vertinimas<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Padedame identifikuoti, kur organizacijoje AI jau naudojamas arba gal\u0117t\u0173 b\u016bti naudojamas, ir \u012fvertiname, ar konkret\u016bs naudojimo atvejai gali paveikti produkto kokyb\u0119, paciento saug\u0105, duomen\u0173 vientisum\u0105 ar GxP procesus.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u012e paslaug\u0105 gali \u012feiti:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>AI use-case inventory;<\/li>\n\n\n\n<li>GxP \/ non-GxP klasifikavimas;<\/li>\n\n\n\n<li>duomen\u0173 jautrumo vertinimas;<\/li>\n\n\n\n<li>AI rizikos matrica;<\/li>\n\n\n\n<li>leid\u017eiam\u0173, ribojam\u0173 ir draud\u017eiam\u0173 AI naudojimo atvej\u0173 s\u0105ra\u0161as;<\/li>\n\n\n\n<li>prioritetinis AI pasiruo\u0161imo veiksm\u0173 planas.<\/li>\n<\/ul>\n<\/div><\/details>\n\n\n\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>AI governance ir SOP paketas<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\">Parengiame praktinius dokumentus, kurie padeda darbuotojams suprasti, kada AI \u012frankiai gali b\u016bti naudojami, kokie duomenys negali b\u016bti \u012fvedami, kada reikalinga \u017emogaus per\u017ei\u016bra ir kaip turi b\u016bti valdoma AI rizika.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u012e paslaug\u0105 gali \u012feiti:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>AI naudojimo politika;<\/li>\n\n\n\n<li>AI governance SOP;<\/li>\n\n\n\n<li>AI rizikos vertinimo \u0161ablonas;<\/li>\n\n\n\n<li>AI output per\u017ei\u016bros SOP;<\/li>\n\n\n\n<li>AI tiek\u0117jo klausimynas;<\/li>\n\n\n\n<li>AI incident\u0173 ir klaid\u0173 valdymo proced\u016bra;<\/li>\n\n\n\n<li>AI change control \u0161ablonas;<\/li>\n\n\n\n<li>darbuotoj\u0173 mokym\u0173 med\u017eiaga.<\/li>\n<\/ul>\n<\/div><\/details>\n\n\n\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>AI tiek\u0117j\u0173 ir \u012franki\u0173 kvalifikavimas<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\">Daug \u012fmoni\u0173 nenaudos nuosavo AI sprendimo, bet \u012fsigis sistemas, kuriose AI funkcijos jau integruotos. Qvalitek padeda \u012fvertinti, ar tokie \u012frankiai tinkami naudoti reguliuojamoje aplinkoje ir koki\u0173 kontrol\u0117s priemoni\u0173 reikia prie\u0161 j\u0173 naudojim\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Vertiname:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>tiek\u0117jo pateikiam\u0105 dokumentacij\u0105;<\/li>\n\n\n\n<li>duomen\u0173 saugumo ir konfidencialumo aspektus;<\/li>\n\n\n\n<li>audit trail, prieigos kontrol\u0119 ir logging galimybes;<\/li>\n\n\n\n<li>modelio ar funkcijos poky\u010di\u0173 valdym\u0105;<\/li>\n\n\n\n<li>GxP poveik\u012f;<\/li>\n\n\n\n<li>duomen\u0173 vientisumo rizikas;<\/li>\n\n\n\n<li>papildomos dokumentacijos ir testavimo poreik\u012f.<\/li>\n<\/ul>\n<\/div><\/details>\n\n\n\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>CSV \/ CSA modernizavimas<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\">Padedame \u012fmon\u0117ms pereiti nuo tradicin\u0117s kompiuterini\u0173 sistem\u0173 validacijos prie rizika gr\u012fstos Computer Software Assurance logikos, ypa\u010d kai planuojama naudoti debesijos, automatizavimo ar AI funkcijas turin\u010dias sistemas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u012e paslaug\u0105 gali \u012feiti:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>esamos CSV metodikos per\u017ei\u016bra;<\/li>\n\n\n\n<li>CSV \/ CSA gap assessment;<\/li>\n\n\n\n<li>rizika gr\u012fsto testavimo modelis;<\/li>\n\n\n\n<li>supplier documentation leverage;<\/li>\n\n\n\n<li>URS, risk assessment, test plan ir validation summary \u0161ablonai;<\/li>\n\n\n\n<li>AI-ready computerized systems gair\u0117s.<\/li>\n<\/ul>\n<\/div><\/details>\n\n\n\n<details class=\"wp-block-themeisle-blocks-accordion-item\"><summary class=\"wp-block-themeisle-blocks-accordion-item__title\"><div><strong>AI GxP mokymai<\/strong><\/div><\/summary><div class=\"wp-block-themeisle-blocks-accordion-item__content\">\n<p class=\"wp-block-paragraph\">Vykdome praktinius mokymus QA, QC, IT, validacijos, gamybos, laboratorij\u0173 ir vadov\u0173 komandoms apie AI galimybes, rizikas ir kontrol\u0117s priemones reguliuojamoje aplinkoje.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Mokym\u0173 temos:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>AI naudojimas GxP aplinkoje;<\/li>\n\n\n\n<li>ChatGPT, Copilot ir kit\u0173 AI \u012franki\u0173 rizikos;<\/li>\n\n\n\n<li>duomen\u0173 konfidencialumas ir duomen\u0173 vientisumas;<\/li>\n\n\n\n<li>AI use-case risk assessment;<\/li>\n\n\n\n<li>AI governance ir SOP;<\/li>\n\n\n\n<li>AI-ready CSV \/ CSA;<\/li>\n\n\n\n<li>\u017emogaus per\u017ei\u016bra ir atsakomyb\u0117 naudojant AI.<\/li>\n<\/ul>\n<\/div><\/details>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Kaip dirbame?<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Situacijos analiz\u0117<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u012evertiname, kokios sistemos, procesai, duomenys ir AI naudojimo atvejai aktual\u016bs j\u016bs\u0173 organizacijai.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Rizikos klasifikavimas<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Atskiriame ma\u017eos, vidutin\u0117s ir auk\u0161tos rizikos naudojimo atvejus, \u012fvertiname GxP poveik\u012f ir duomen\u0173 jautrum\u0105.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Kontrol\u0117s priemoni\u0173 parinkimas<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Parengiame rekomendacijas d\u0117l SOP, mokym\u0173, tiek\u0117j\u0173 vertinimo, change control, output review ir validacijos strategijos.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Dokumentacija ir mokymai<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Paruo\u0161iame praktinius dokumentus, \u0161ablonus ir mokym\u0173 med\u017eiag\u0105, kuri\u0105 galima integruoti \u012f \u012fmon\u0117s kokyb\u0117s sistem\u0105.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Pasiruo\u0161imas bandomajam projektui<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Padedame pasirinkti saugius, kontroliuojamus ir audituojamus AI naudojimo atvejus ateities bandomiesiems projektams.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div id=\"wp-block-themeisle-blocks-button-group-415d7592\" class=\"wp-block-themeisle-blocks-button-group wp-block-buttons align-center-desktop\">\n<div id=\"wp-block-themeisle-blocks-button-9414febf\" class=\"wp-block-themeisle-blocks-button wp-block-button\"><a href=\"https:\/\/www.qvalitek.com\/lt\/contact-us\/\" target=\"_self\" rel=\"noopener noreferrer\" class=\"wp-block-button__link\"><span><strong>Susisiekite!<\/strong><\/span><\/a><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>For regulated companies, it is not enough to test new technologies. Their use must be controlled, documented, auditable and aligned with GxP, GMP, CSV, CSA and data integrity principles. Qvalitek helps companies prepare for controlled AI and digital quality system use: we assess risks, prepare governance documents, SOPs, vendor assessment [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_themeisle_gutenberg_block_has_review":false,"footnotes":""},"class_list":["post-831","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Digital Quality and AI Compliance - QVALITEK<\/title>\n<meta name=\"description\" content=\"AI risk assessment, AI governance, SOPs, vendor qualification, CSV \/ CSA and training for regulated GxP companies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.qvalitek.com\/lt\/digital-quality-and-ai-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"lt_LT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital Quality and AI Compliance - 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