{"title":"Computer System Validation (CSV)","description":"\u003cp\u003eLa collezione \u003cstrong data-start=\"14\" data-end=\"50\"\u003eComputer System Validation (CSV)\u003c\/strong\u003e raccoglie guide operative e strumenti pratici per validare sistemi computerizzati in ambito GxP (CSV\/CSA, GAMP 5, Annex 11, 21 CFR Part 11), aiutando QA, IT e Validation a garantire \u003cstrong data-start=\"233\" data-end=\"293\"\u003ecompliance regolatoria, data integrity e audit readiness\u003c\/strong\u003e lungo tutto il ciclo di vita dei sistemi.\u003c\/p\u003e","products":[{"product_id":"guida-operativa-alla-computer-system-validation-csv-in-ambito-gxp","title":"Guida Operativa alla Computer System Validation (CSV) in Ambito GxP","description":"\u003cp data-start=\"213\" data-end=\"465\"\u003eLa \u003cstrong data-start=\"216\" data-end=\"252\"\u003eComputer System Validation (CSV)\u003c\/strong\u003e è un requisito essenziale per garantire che i \u003cstrong data-start=\"299\" data-end=\"329\"\u003esistemi computerizzati GxP\u003c\/strong\u003e siano affidabili, conformi e sotto controllo, in linea con \u003cstrong data-start=\"389\" data-end=\"408\"\u003eEU GMP Annex 11\u003c\/strong\u003e, \u003cstrong data-start=\"410\" data-end=\"432\"\u003eFDA 21 CFR Part 11\u003c\/strong\u003e e le linee guida internazionali.\u003c\/p\u003e\n\u003cp data-start=\"467\" data-end=\"693\"\u003eQuesta guida operativa fornisce un approccio \u003cstrong data-start=\"512\" data-end=\"536\"\u003epratico e risk-based\u003c\/strong\u003e alla CSV, integrando i principi di \u003cstrong data-start=\"572\" data-end=\"609\"\u003eComputer Software Assurance (CSA)\u003c\/strong\u003e e trasformando la normativa in \u003cstrong data-start=\"641\" data-end=\"692\"\u003eprocessi operativi e documentazione audit-ready\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-start=\"700\" data-end=\"728\"\u003eCosa troverai nella guida\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli data-start=\"732\" data-end=\"789\"\u003equadro normativo CSV (Annex 11, Part 11, GAMP 5, PIC\/S)\u003c\/li\u003e\n\u003cli data-start=\"792\" data-end=\"844\"\u003eapproccio moderno \u003cstrong data-start=\"810\" data-end=\"823\"\u003eCSV → CSA\u003c\/strong\u003e basato sul rischio\u003c\/li\u003e\n\u003cli data-start=\"847\" data-end=\"889\"\u003elifecycle del sistema: URS, FS, IQ\/OQ\/PQ\u003c\/li\u003e\n\u003cli data-start=\"892\" data-end=\"939\"\u003egestione fornitori e sistemi \u003cstrong data-start=\"921\" data-end=\"937\"\u003eCloud \/ SaaS\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"942\" data-end=\"989\"\u003edata integrity, audit trail, accessi e backup\u003c\/li\u003e\n\u003cli data-start=\"992\" data-end=\"1043\"\u003echange control, periodic review e decommissioning\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"1050\" data-end=\"1070\"\u003eA chi è destinata\u003c\/h2\u003e\n\u003cp data-start=\"1072\" data-end=\"1184\"\u003eQA, CSV\/CSA Manager, IT, Validation, Regulatory Affairs, QP e team coinvolti nei \u003cstrong data-start=\"1153\" data-end=\"1183\"\u003esistemi computerizzati GxP\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-end=\"1147\" data-start=\"1123\"\u003eDettagli del prodotto\u003c\/h2\u003e\n\u003cp data-start=\"1324\" data-end=\"1436\"\u003e\u003cstrong data-start=\"1324\" data-end=\"1336\"\u003eFormato:\u003c\/strong\u003e PDF professionale\u003cbr data-start=\"1354\" data-end=\"1357\"\u003e\u003cstrong data-start=\"1357\" data-end=\"1371\"\u003ePagine:\u003c\/strong\u003e 152 pagine\u003cbr data-start=\"1382\" data-end=\"1385\"\u003e\u003cstrong data-start=\"1385\" data-end=\"1403\"\u003eAggiornata a:\u003c\/strong\u003e Gennaio 2026\u003cbr data-start=\"1416\" data-end=\"1419\"\u003e\u003cstrong data-start=\"1419\" data-end=\"1430\"\u003eLingue:\u003c\/strong\u003e ITA - ENG\u003c\/p\u003e\n\u003cp data-start=\"4025\" data-end=\"4130\"\u003e\u003cstrong\u003eSCARICA UNA PREVIEW DELLA GUIDA\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable style=\"width: 54.1%; 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border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;\" width=\"54%\" cellpadding=\"0\" cellspacing=\"0\" border=\"1\" class=\"MsoTableGrid\"\u003e\n\u003ctbody\u003e\n\u003ctr style=\"mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: yes;\"\u003e\n\u003ctd style=\"width: 48.2%; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"48%\"\u003e\n\u003cp style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\" class=\"MsoNormal\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Guida_al_Computer_Software_Assurance_CSA__ITA_PREVIEW.pdf?v=1767178965\" rel=\"noopener\" target=\"_blank\"\u003e\u003cb\u003ePreview ITA \u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003ctd style=\"width: 50.9%; border: solid windowtext 1.0pt; border-left: none; mso-border-left-alt: solid windowtext .5pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"50%\"\u003e\n\u003cp style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\" class=\"MsoNormal\"\u003e\u003cb\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Guide_to_Computer_Software_Assurance_CSA__ENG_PREVIEW.pdf?v=1767179000\" rel=\"noopener\" target=\"_blank\"\u003ePreview ENG \u003c\/a\u003e\u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Operational_Guide_to_GMP_Cleaning_Validation_ENG_PREVIEW.pdf?v=1766920760\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/ALCOA_operational_Guide_to_Data_Integrity_ENG_PREVIEW.pdf?v=1764867387\" title=\"ALCOA+ \u0026amp; Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma\" rel=\"noopener\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"GuideGxP","offers":[{"title":"ENG - English","offer_id":53688702009674,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53688702042442,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/CSA_Computer_software_assurance__COVER.png?v=1767178637"},{"product_id":"saas-cloud-validation-guida-gxp-toolkit","title":"SaaS \u0026 Cloud Validation: Guida all’Implementazione GxP + template","description":"\u003cp data-path-to-node=\"6\"\u003e\u003cb data-index-in-node=\"0\" data-path-to-node=\"6\"\u003eConvalida il Cloud senza stress. La guida operativa definitiva per il mondo Pharma.\u003c\/b\u003e\u003c\/p\u003e\n\u003cp data-path-to-node=\"7\"\u003eL'adozione del Cloud e del SaaS nel settore Life Science non è più il futuro, è il presente. Ma come si conciliano innovazione e agilità con i rigidi requisiti \u003cb data-index-in-node=\"160\" data-path-to-node=\"7\"\u003eFDA 21 CFR Part 11\u003c\/b\u003e e \u003cb data-index-in-node=\"181\" data-path-to-node=\"7\"\u003eEU GMP Annex 11\u003c\/b\u003e? Questa guida non è il solito manuale teorico. È uno strumento di lavoro pratico, progettato per \u003cb data-index-in-node=\"96\" data-path-to-node=\"8\"\u003eQA Manager, IT Specialist e Validation Expert\u003c\/b\u003e che devono implementare, convalidare e mantenere sistemi cloud in conformità GxP.\u003c\/p\u003e\n\u003cp data-path-to-node=\"9\"\u003eAggiornata ai principi \u003cb data-index-in-node=\"23\" data-path-to-node=\"9\"\u003eGAMP 5 Seconda Edizione\u003c\/b\u003e e alle logiche di \u003cb data-index-in-node=\"65\" data-path-to-node=\"9\"\u003eCSA (Computer Software Assurance)\u003c\/b\u003e, questa guida ti accompagna passo dopo passo dalla strategia di convalida fino alla preparazione per l'ispezione.\u003c\/p\u003e\n\u003cp data-path-to-node=\"10\"\u003e\u003cb data-index-in-node=\"0\" data-path-to-node=\"10\"\u003eCosa imparerai:\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-path-to-node=\"11,0,0\"\u003e\n\u003cb data-index-in-node=\"0\" data-path-to-node=\"11,0,0\"\u003eStrategia Cloud:\u003c\/b\u003e Come gestire i modelli IaaS, PaaS e SaaS e il \"Shared Responsibility Model\".\u003c\/li\u003e\n\u003cli data-path-to-node=\"11,1,0\"\u003e\n\u003cb data-index-in-node=\"0\" data-path-to-node=\"11,1,0\"\u003eNormative Spiegate:\u003c\/b\u003e I requisiti essenziali di FDA Part 11, Annex 11 e Data Integrity (ALCOA+) tradotti in azioni pratiche.\u003c\/li\u003e\n\u003cli data-path-to-node=\"11,2,0\"\u003e\n\u003cb data-index-in-node=\"0\" data-path-to-node=\"11,2,0\"\u003eVendor Management:\u003c\/b\u003e Come auditare e qualificare i fornitori Cloud (anche i colossi come AWS\/Azure).\u003c\/li\u003e\n\u003cli data-path-to-node=\"11,3,0\"\u003e\n\u003cb data-index-in-node=\"0\" data-path-to-node=\"11,3,0\"\u003eCiclo di Vita:\u003c\/b\u003e Dalla URS al Go-Live, passando per Risk Assessment e Testing (IQ\/OQ\/PQ) ottimizzati.\u003c\/li\u003e\n\u003cli data-path-to-node=\"11,4,0\"\u003e\n\u003cb data-index-in-node=\"0\" data-path-to-node=\"11,4,0\"\u003eAudit Readiness:\u003c\/b\u003e Come presentare un sistema SaaS a un ispettore ed evitare le osservazioni più comuni.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-path-to-node=\"12\"\u003e\u003cb data-index-in-node=\"0\" data-path-to-node=\"12\"\u003e📦 BONUS INCLUSO: Il Toolkit Operativo \u003c\/b\u003e\u003c\/p\u003e\n\u003cp data-path-to-node=\"12\"\u003eAll'interno della guida troverai \u003cb data-index-in-node=\"130\" data-path-to-node=\"12\"\u003e7 Checklist\u003c\/b\u003e e \u003cb data-index-in-node=\"144\" data-path-to-node=\"12\"\u003e9 Template pronti all'uso\u003c\/b\u003e per rendere il tuo sistema \"Audit-Ready\" immediatamente:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-path-to-node=\"13,0,0\"\u003e✅ \u003cb data-index-in-node=\"2\" data-path-to-node=\"13,0,0\"\u003eChecklist:\u003c\/b\u003e Valutazione Fornitore, Assessment Part 11\/Annex 11, Data Integrity Check, Audit Prep, e altro.\u003c\/li\u003e\n\u003cli data-path-to-node=\"13,1,0\"\u003e📝 \u003cb data-index-in-node=\"3\" data-path-to-node=\"13,1,0\"\u003eTemplate:\u003c\/b\u003e Piano di Convalida (Validation Plan), URS, Matrice di Tracciabilità, Protocolli e Report IQ\/OQ\/PQ, Registro Change Control e altro.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"1123\" data-end=\"1147\"\u003eDettagli del prodotto\u003c\/h2\u003e\n\u003cp data-end=\"1436\" data-start=\"1324\"\u003e\u003cstrong data-end=\"1336\" data-start=\"1324\"\u003eFormato:\u003c\/strong\u003e PDF professionale\u003cbr data-end=\"1357\" data-start=\"1354\"\u003e\u003cstrong data-end=\"1371\" data-start=\"1357\"\u003ePagine:\u003c\/strong\u003e 193 pagine\u003cbr data-end=\"1385\" data-start=\"1382\"\u003e\u003cstrong data-end=\"1403\" data-start=\"1385\"\u003eAggiornata a:\u003c\/strong\u003e Gennaio 2026\u003cbr data-end=\"1419\" data-start=\"1416\"\u003e\u003cstrong data-end=\"1430\" data-start=\"1419\"\u003eLingue:\u003c\/strong\u003e ITA - ENG\u003c\/p\u003e\n\u003cp data-end=\"4130\" data-start=\"4025\"\u003e\u003cstrong\u003eSCARICA UNA PREVIEW DELLA GUIDA\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable class=\"MsoTableGrid\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"54%\" style=\"width: 54.1%; border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;\"\u003e\n\u003ctbody\u003e\n\u003ctr style=\"mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: yes;\"\u003e\n\u003ctd width=\"48%\" valign=\"top\" style=\"width: 48.2%; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt;\"\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/SaaS_Cloud_Validation_guida_GxP_ITA_PREVIEW.pdf?v=1768062879\" rel=\"noopener\" target=\"_blank\"\u003e\u003cb\u003ePreview ITA \u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003ctd width=\"50%\" valign=\"top\" style=\"width: 50.9%; border: solid windowtext 1.0pt; border-left: none; mso-border-left-alt: solid windowtext .5pt; mso-border-alt: solid windowtext .5pt; 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