{"id":1594,"date":"2026-09-25T09:25:36","date_gmt":"2026-09-25T07:25:36","guid":{"rendered":"https:\/\/rijat-pharma.eu\/quality\/"},"modified":"2026-09-29T12:09:15","modified_gmt":"2026-09-29T10:09:15","slug":"quality","status":"publish","type":"page","link":"https:\/\/rijat-pharma.eu\/en\/quality\/","title":{"rendered":"Quality"},"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>Ready to produce.<\/strong><\/h1>\n<p><\/p>\n<h1 style=\"color: #21bfd2;\">Ready to audit.<\/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>The more technical information you share, the more specific our first response can be.<\/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>Design for compliance<br \/>\n<\/strong><\/h2>\n<p><\/p>\n<p>Regulatory requirements translate into design, automation, materials, and documentation decisions from the start<\/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 <\/strong><\/h2>\n<p><\/p>\n<p>Risk analysis guides controls, testing, and evidence, avoiding generic documentation that has no connection to the process.<\/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 <\/strong><\/h2>\n<p><\/p>\n<p>We link requirements, specifications, risks, and tests so that each criterion has verifiable evidence.<\/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 <\/strong><\/h2>\n<p><\/p>\n<p>When the scope requires it, we include users, roles, audit trails, electronic records, and backup strategies.<\/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>APPLICABLE FRAMEWORKS<\/strong><\/p>\n<p><\/p>\n<h2>The right scope for each project.<\/h2>\n<p><\/p>\n<p>RIJAT designs according to the applicable requirements agreed with the client. The inclusion of each frame depends on the product, intended use, control architecture, and country of installation.<\/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><\/p>\n<p>Safety, risk assessment, and technical file<\/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><\/p>\n<p>Annex 1 and Annex 11 when they are applicable<\/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><\/p>\n<p>Lifecycle and risk-based approach<\/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><\/p>\n<p>Part 11-ready controls according to functional scope<\/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>APPLICABLE FRAMEWORKS<\/strong><\/p>\n<p><\/p>\n<h2>Documentation that connects requirements and evidence.<\/h2>\n<p><\/p>\n<p>RIJAT designs according to the applicable requirements agreed with the client. The inclusion of each frame depends on the product, intended use, control architecture, and country of installation.<\/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;\">QUALITY POLICY<\/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>Accuracy in statements.<\/h2>\n<p><\/p>\n<h2>\u00a0<\/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\">GMP, GAMP 5, and 21 CFR Part 11 are presented as design and compliance frameworks applicable to the project, not as universal certifications for all machines.<\/div>\n<\/section>\n<p><\/p>\n<section class=\"project-cta\">\n<div class=\"shell project-cta__inner\">\n<div>\u00a0<\/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>\u00bfDo you have a URS or a process to sort out?<\/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>Share the product, packaging, cadence, and target market. Our technical team will structure the next step.<\/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\/en\/contact-2\/\" data-icon=\"&amp;\">Send requirements<\/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-1594","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>Quality - Rijat Pharma<\/title>\n<meta name=\"description\" content=\"Quality\" \/>\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\/en\/quality\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality - 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