{"id":1578,"date":"2026-09-25T09:25:36","date_gmt":"2026-09-25T07:25:36","guid":{"rendered":"https:\/\/rijat-pharma.eu\/?page_id=1578"},"modified":"2026-09-29T12:09:15","modified_gmt":"2026-09-29T10:09:15","slug":"qualitat","status":"publish","type":"page","link":"https:\/\/rijat-pharma.eu\/ca\/qualitat\/","title":{"rendered":"Qualitat"},"content":{"rendered":"\r\n\r\n<div class=\"et_pb_section_0 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_0 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_0 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_0 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><strong><span>BUILT IN BARCELONA<\/span><\/strong><\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h1 style=\"color: white;\"><strong>Preparada per produir.<\/strong><\/h1>\n<p><\/p>\n<h1 style=\"color: #21bfd2;\">Preparada per auditar.<\/h1>\n<p><\/p>\n<p><strong><\/strong><\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_2 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Com m\u00e9s informaci\u00f3 t\u00e8cnica comparteixis, m\u00e9s concreta podr\u00e0 ser la nostra primera resposta.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_section_1 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_1 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_1 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_6_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_3 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"color: #21bfd2;\"><strong>01<\/strong><\/p>\n<p><\/p>\n<h2><strong>Disseny per al compliment<br \/>\n<\/strong><\/h2>\n<p><\/p>\n<p>Els requisits normatius es tradueixen en decisions de disseny, automatitzaci\u00f3, materials i documentaci\u00f3 des del principi<\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_2 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_6_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_4 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"color: #21bfd2;\"><strong>02<\/strong><\/p>\n<p><\/p>\n<h2><strong>Risk-based approach<br \/>\n<\/strong><\/h2>\n<p><\/p>\n<p>L'an\u00e0lisi de riscos orienta controls, proves i evid\u00e8ncia, evitant documentaci\u00f3 gen\u00e8rica sense relaci\u00f3 amb el proc\u00e9s.<\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_3 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_6_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_5 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"color: #21bfd2;\"><strong>03<\/strong><\/p>\n<p><\/p>\n<h2><strong>Traceability<br \/>\n<\/strong><\/h2>\n<p><\/p>\n<p>Vinculem requisits, especificacions, riscos i proves perqu\u00e8 cada criteri tingui una evid\u00e8ncia verificable.<\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_4 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_6_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_6 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"color: #21bfd2;\"><strong>04<\/strong><\/p>\n<p><\/p>\n<h2><strong>Data integrity<br \/>\n<\/strong><\/h2>\n<p><\/p>\n<p>Quan l'abast ho requereix, incorporem usuaris, rols, rastre d'auditoria, registres electr\u00f2nics i estrat\u00e8gies de c\u00f2pia de seguretat.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_section_2 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_2 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_5 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_7 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><strong><span>APPLICABLE FRAMEWORKS<\/strong><\/span><\/p>\n<p><\/p>\n<h2>L'abast correcte per a cada projecte.<\/h2>\n<p><\/p>\n<p>RIJAT dissenya segons els requisits aplicables acordats amb el client. La inclusi\u00f3 de cada marc dep\u00e8n del producte, l'\u00fas previst, l'arquitectura de control i el pa\u00eds d'instal\u00b7laci\u00f3.<\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_6 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_row_3 et_pb_row et_pb_row_nested et_flex_row\">\r\n\r\n<div class=\"et_pb_column_7 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_8 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"font-size:20px;\"><strong>CE<\/strong><\/p>\n<p>Seguretat, avaluaci\u00f3 de riscos i expedient t\u00e8cnic<\/p>\n<p><\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_8 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_9 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p  style=\"font-size:20px;\"><strong>EU GMP<\/strong><\/p>\n<p>Annex 1 i Annex 11 quan resulten aplicables<\/p>\n<p><\/p>\n<\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_row_4 et_pb_row et_pb_row_nested et_flex_row\">\r\n\r\n<div class=\"et_pb_column_9 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_10 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p  style=\"font-size:20px;\"><strong>GAMP 5<\/strong><\/p>\n<p>Cicle de vida i enfocament basat en el risc<\/p>\n<p><\/p>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_10 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_11 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p  style=\"font-size:20px;\"><strong>21 CFR<\/strong><\/p>\n<p>Controls Part 11-ready segons l'abast funcional<\/p>\n<p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_section_3 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_5 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_11 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_12 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p style=\"color: #21bfd2;\"><strong><span>APPLICABLE FRAMEWORKS<\/span><\/strong><\/p>\n<p><\/p>\n<h2>Documentaci\u00f3 que connecta requisits i evid\u00e8ncia.<\/h2>\n<p><\/p>\n<p>RIJAT dissenya segons els requisits aplicables acordats amb el client. La inclusi\u00f3 de cada marc dep\u00e8n del producte, l'\u00fas previst, l'arquitectura de control i el pa\u00eds d'instal\u00b7laci\u00f3.<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_0_wrapper\"><a class=\"et_pb_button_0 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"\" data-icon=\"&amp;\">POL\u00cdTICA DE QUALITAT<\/a><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_12 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_13 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>01\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Project Quality Plan<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_14 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>02\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>URS review &amp; traceability matrix<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_15 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>03\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Functional \/ hardware \/ software specifications<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_16 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>04\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Design risk assessment<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_17 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>05\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Material certificates and component traceability<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_18 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>06\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>FAT \/ SAT protocols and reports<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_19 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>07\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Material certificates and component traceability<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_20 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><span style=\"color: #21bfd2;\"><strong>08\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 <\/strong><\/span>Manuals, drawings, backups and as-built package<\/p>\n<\/div><\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_section_4 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_6 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_13 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_8_24 et_flex_column_8_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_21 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h2>Precisi\u00f3 en les afirmacions.<\/p>\n<h2>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_14 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_24_24 et_flex_column_24_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_22 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><section class=\"quality-disclaimer\">\n<div class=\"shell\">\n<p>GMP, GAMP 5 i 21 CFR Part 11 es presenten com a marcs de disseny i compliment aplicables al projecte; no com a certificacions universals de totes les m\u00e0quines.<\/p>\n<\/div>\n<\/section>\n<p><\/p>\n<section class=\"project-cta\">\n<div class=\"shell project-cta__inner\">\n<div><\/div>\n<\/div>\n<\/section>\n<\/div><\/div><\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_section_5 et_pb_section et_section_regular et_flex_section\">\r\n\r\n<div class=\"et_pb_row_7 et_pb_row et_flex_row\">\r\n\r\n<div class=\"et_pb_column_15 et_pb_column et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_23 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p><strong>START A PROJECT<\/strong><\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_text_24 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><h2>\u00bfTens una URS o un proc\u00e9s per resoldre?<\/h2>\n<\/div><\/div><\/div>\r\n\r\n<div class=\"et_pb_column_16 et_pb_column et-last-child et_flex_column et_pb_css_mix_blend_mode_passthrough et_flex_column_12_24 et_flex_column_12_24_tablet et_flex_column_24_24_phone\">\r\n\r\n<div class=\"et_pb_text_25 et_pb_text et_pb_bg_layout_light et_pb_module et_flex_module\"><div class=\"et_pb_text_inner\"><p>Comparte producte, env\u00e0s, cad\u00e8ncia i mercat de destinaci\u00f3. El nostre equip t\u00e8cnic estructurar\u00e0 el seg\u00fcent pas.<\/p>\n<p><\/p>\n<p>&nbsp;<\/p>\n<\/div><\/div>\r\n\r\n<div class=\"et_pb_module et_pb_button_module_wrapper et_pb_button_1_wrapper\"><a class=\"et_pb_button_1 et_pb_button et_pb_bg_layout_light et_pb_module et_flex_module\" href=\"https:\/\/rijat-pharma.eu\/ca\/contacte-2\/\" data-icon=\"&amp;\">Enviar requisits<\/a><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1578","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qualitat - Rijat Pharma<\/title>\n<meta name=\"description\" content=\"Qualitat\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/rijat-pharma.eu\/ca\/qualitat\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qualitat - 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