{"id":967,"date":"2025-10-21T17:47:56","date_gmt":"2025-10-21T15:47:56","guid":{"rendered":"https:\/\/www.supera-kvaliteta.hr\/validations\/"},"modified":"2026-01-24T18:36:08","modified_gmt":"2026-01-24T17:36:08","slug":"validations","status":"publish","type":"page","link":"https:\/\/www.supera-kvaliteta.hr\/en\/validations\/","title":{"rendered":"Validations"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container us_custom_6cc09829\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column h1-small\"><div class=\"wpb_wrapper\"><h1 style=\"text-align: center;\">Validations<\/h1>\n<div class=\"mod_tquote_quote\">\n<blockquote>\n<p><b>&#8220;To dare is the price of progress.&#8221;<\/b> | <i>Victor Hugo<\/i><\/p>\n<\/blockquote>\n<\/div>\n<p>SUPERA KVALITETA provides <strong>business consulting services<\/strong> for activities related to:<\/p>\n<p><strong>computer system validation, small application validation, cleaning validation, process validation, equipment qualification<\/strong><\/p>\n<\/div><\/div><div class=\"g-cols wpb_row us_custom_077df5e3 via_grid cols_1-4 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"604\" height=\"340\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_6.jpg\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_6.jpg 604w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_6-300x169.jpg 300w\" sizes=\"auto, (max-width: 604px) 100vw, 604px\" \/><\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Validation of information, laboratory and process systems and maintenance of computer systems in a validated state in compliance with applicable guidelines and guides: EU GMP Annex 11, ISPE GAMP 5, FDA 21 CFR Part 11 (for systems using electronic records and signatures) covers <strong>activities<\/strong>:<\/p>\n<ul>\n<li>assistance in the preparation and \/ or review of validation documentation for all phases of the computer system life cycle (planning, specifications, development, installation qualification, operation qualification, performance qualification, &#8220;go-live&#8221;)<\/li>\n<li>assistance in producing the necessary procedures (SOP &#8211; Standard Operating Procedure)<\/li>\n<li>risk analysis<\/li>\n<li>audit of vendor<\/li>\n<li>performing education<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row us_custom_4f916de3 via_grid cols_4-1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>We provide support for the creation and <strong>validation of small applications<\/strong> (Access, Excel, FileMaker) used in the GxP environment that must be validated.<\/p>\n<\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"457\" height=\"340\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_7.jpg\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_7.jpg 457w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_7-300x223.jpg 300w\" sizes=\"auto, (max-width: 457px) 100vw, 457px\" \/><\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row us_custom_4f916de3 via_grid cols_1-4 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"336\" height=\"240\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_2.jpg\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_2.jpg 336w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Val_rac_sust_2-300x214.jpg 300w\" sizes=\"auto, (max-width: 336px) 100vw, 336px\" \/><\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>We also provide support services for compliance of systems, computer systems and procedures with <strong>data integrity<\/strong> requirements in accordance with applicable guidelines.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row us_custom_4f916de3 via_grid cols_4-1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container justify-content-center type_sticky\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><strong>Cleaning validation<\/strong> &#8211; the purpose of cleaning validation is to confirm that the cleaning process is effective and to ensure that the medicinal product is safe by preventing cross-contamination.<\/p>\n<\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"216\" height=\"194\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Validacija_ciscenja_1.png\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" \/><\/div><\/div><\/div><\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><strong>Validation<\/strong><span> <\/span>Ceaning validation and maintenance of validated status in compliance with applicable Guidelines and Guides: EU GMP Vol 4. Part I and Part II, EU GMP Annex 15, PIC \/ S PI 006, APIC Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, FDA Guide to inspections validation of cleaning processes, ICH Guidelines, VICH<span> <\/span>Guidelines, covers<span> <\/span><strong>activities:<\/strong><\/p>\n<ul>\n<li>assistance in preparation and \/ or review of validation documentation (validation master plan (VMP), cleaning validation protocol, cleaning validation report, descriptions of cleaning procedures &#8211; SOPs, work instructions, etc.)<\/li>\n<li>assistance in creating a product equipment matrix and grouping products<\/li>\n<li>assistance to set eligibility criteria and to calculate limits for the rest of the product<\/li>\n<li>risk analysis<\/li>\n<li>performing education<\/li>\n<\/ul>\n<\/div><\/div><div class=\"g-cols wpb_row us_custom_077df5e3 via_grid cols_1-4 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"1024\" height=\"702\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Validacije_validacija_procesa-1024x702.png\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Validacije_validacija_procesa-1024x702.png 1024w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Validacije_validacija_procesa-300x206.png 300w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Validacije_validacija_procesa.png 1086w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><strong>Process validation <\/strong>&#8211; documented evidence that a process run within set parameters can effectively and reproducibly produce a product that complies with predefined specifications and quality characteristics.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Process validation in accordance with applicable guidelines and guides: EU GMP Annex 15, EU GMP Chapter 5, EMA Guideline on Process Validation, FDA Guidance for Industry Process Validation, includes <strong>activities<\/strong>:<\/p>\n<ul>\n<li>assistance in the preparation and \/ or review of validation documentation (validation master plan (VMP), validation protocol (validation plan), validation report)<\/li>\n<li>risk analysis<\/li>\n<li>consulting in the field of modern approaches to process development and validation: Quality by Design (QbD), Process Analytical Technology (PAT), Continued Process Verification<\/li>\n<li>performing education<\/li>\n<\/ul>\n<\/div><\/div><div class=\"g-cols wpb_row us_custom_077df5e3 via_grid cols_4-1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\" style=\"--gap:2rem;\"><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><strong>Equipment qualification<\/strong> &#8211; process that proves and documents that the equipment is functioning properly and that it really produces the expected results.<\/p>\n<\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container justify-content-center\"><div class=\"vc_column-inner\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"354\" height=\"158\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Kvalifikacija_Picture1.png\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Kvalifikacija_Picture1.png 354w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/Kvalifikacija_Picture1-300x134.png 300w\" sizes=\"auto, (max-width: 354px) 100vw, 354px\" \/><\/div><\/div><\/div><\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><div id=\"s5_center_column_wrap\">\n<div id=\"s5_center_column_wrap_inner\" class=\"s5_resize_center_columns\">\n<div id=\"s5_component_wrap\">\n<div id=\"s5_component_wrap_inner\">\n<div class=\"item-page\">\n<div>\n<p><strong>Equipment qualification<\/strong><span> <\/span>in accordance with applicable guidelines and guides:<span> <\/span>EU GMP Vol 4. Part I and Part II, EU GMP Annex 15, EMA Guideline on Process Validation,<span> <\/span>PIC \/ S PI 006, WHO Annex 4 &#8211; Appendix 6,<span> <\/span>FDA Guidance for Industry Process Validation, includes<span> <\/span><strong>activities:<\/strong><\/p>\n<ul>\n<li>assistance in the preparation and \/ or review of qualification documentation (User Requirements Specification (URS), Design Qualification &#8211; DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing &#8211; SAT), Installation Qualification &#8211; IQ, Operational Qualification &#8211; OQ, Performance Qualification &#8211; PQ<\/li>\n<li>analizu rizika <\/li>\n<li>performing education<\/li>\n<\/ul>\n<p>We organize and perform in-house trainings in English language for computer system validation, small application validation, cleaning validation, process validation, equipment qualification and other <a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\">similar topics<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":966,"parent":0,"menu_order":46,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-967","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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