{"title":"AI e Sistemi Computerizzati GxP","description":"\u003cp\u003eGuide operative su intelligenza artificiale in ambito GMP (Annex 22), validazione dei sistemi computerizzati (CSV\/CSA), cloud e SaaS, data governance ALCOA+.\u003c\/p\u003e","products":[{"product_id":"alcoa-data-governance-la-guida-operativa-definitiva-per-la-data-integrity-pharma","title":"ALCOA+ \u0026 Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity","description":"\u003cp data-start=\"254\" data-end=\"614\"\u003eThe most comprehensive guide for QA, QC, IT, Manufacturing and Validation professionals who must implement a solid, modern and fully compliant Data Integrity system.\u003cbr data-start=\"419\" data-end=\"422\"\u003eIt provides an operational walkthrough of ALCOA+ principles, Data Governance, the Data Lifecycle and the full Data Integrity Risk Assessment (DIRA) process required by international standards.\u003c\/p\u003e\n\u003cp data-start=\"616\" data-end=\"641\"\u003e\u003cstrong data-start=\"616\" data-end=\"641\"\u003eInside you will find:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"643\" data-end=\"1442\"\u003e📌 \u003cstrong data-start=\"646\" data-end=\"698\"\u003ePractical explanation of the 9 ALCOA+ attributes\u003c\/strong\u003e, with examples and application across GMP departments.\u003cbr data-start=\"753\" data-end=\"756\"\u003e🏛️ \u003cstrong data-start=\"760\" data-end=\"785\"\u003eData Governance model\u003c\/strong\u003e including roles, responsibilities, KPIs and integration within the PQS.\u003cbr data-start=\"857\" data-end=\"860\"\u003e🔄 \u003cstrong data-start=\"863\" data-end=\"909\"\u003eComplete management of the Data Lifecycle:\u003c\/strong\u003e generation → recording → processing → archiving → retrieval.\u003cbr data-start=\"970\" data-end=\"973\"\u003e🛡️ \u003cstrong data-start=\"977\" data-end=\"1032\"\u003eStructured methodology to conduct an effective DIRA\u003c\/strong\u003e, with typical risks and actionable mitigations.\u003cbr data-start=\"1080\" data-end=\"1083\"\u003e⚠️ \u003cstrong data-start=\"1086\" data-end=\"1125\"\u003eCommon issues identified by FDA\/EMA\u003c\/strong\u003e (backdating, uncontrolled copies, disabled audit trails, unqualified data migrations).\u003cbr data-start=\"1212\" data-end=\"1215\"\u003e📝 \u003cstrong data-start=\"1218\" data-end=\"1245\"\u003eProfessional templates:\u003c\/strong\u003e DIRA form, Data Integrity SOP, Audit Trail Review log, data-flow inventory, audit checklist.\u003cbr data-start=\"1338\" data-end=\"1341\"\u003e🔍 \u003cstrong data-start=\"1344\" data-end=\"1368\"\u003eAudit-ready approach\u003c\/strong\u003e for EMA\/FDA inspections, with real examples of observed non-conformities.\u003c\/p\u003e\n\u003cp data-start=\"1444\" data-end=\"1565\"\u003ePerfect for QA Managers, QC Analysts, Data Owners, IT\/CSV Specialists, Production Supervisors and Validation Specialists.\u003c\/p\u003e\n\u003cp data-start=\"1567\" data-end=\"1676\"\u003e\u003cstrong data-start=\"1567\" data-end=\"1578\"\u003eFormat:\u003c\/strong\u003e Professional PDF\u003cbr data-start=\"1595\" data-end=\"1598\"\u003e\u003cstrong data-start=\"1598\" data-end=\"1609\"\u003eLength:\u003c\/strong\u003e 92 pages\u003cbr data-start=\"1618\" data-end=\"1621\"\u003e\u003cstrong data-start=\"1621\" data-end=\"1633\"\u003eUpdated:\u003c\/strong\u003e December 2025\u003cbr data-start=\"1647\" data-end=\"1650\"\u003e\u003cstrong data-start=\"1650\" data-end=\"1664\"\u003eLanguages:\u003c\/strong\u003e ITA – ENG\u003c\/p\u003e\n\u003cp data-start=\"1678\" data-end=\"1713\"\u003e\u003cstrong data-start=\"1678\" data-end=\"1713\"\u003eDOWNLOAD A PREVIEW OF THE GUIDE\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 rel=\"noopener\" title=\"ALCOA+ \u0026amp; Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/ALCOA_Data_Governance_PREVIEW_ITA.pdf?v=1764867342\" 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; padding: 0cm 5.4pt 0cm 5.4pt;\"\u003e\n\u003cp class=\"MsoNormal\" style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\"\u003e\u003ca rel=\"noopener\" title=\"ALCOA+ \u0026amp; Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/ALCOA_operational_Guide_to_Data_Integrity_ENG_PREVIEW.pdf?v=1764867387\" target=\"_blank\"\u003e\u003cb\u003ePreview ENG\u0026nbsp;\u003c\/b\u003e\u003c\/a\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":53516225511754,"sku":null,"price":49.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53516225544522,"sku":null,"price":49.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/06-alcoa-data-governance.png?v=1784927061"},{"product_id":"guida-operativa-alla-computer-system-validation-csv-in-ambito-gxp","title":"Operational Guide to Computer System Validation (CSV) in the GxP Environment","description":"\u003cdiv\u003e\u003cdiv style=\"background:#14243a;border-radius:12px;padding:28px 24px;color:#ffffff;margin:0 0 22px\"\u003e\u003cp style=\"margin:0 0 12px\"\u003e\u003cspan style=\"background:#c9a227;color:#14243a;font-weight:700;font-size:12px;letter-spacing:1px;padding:4px 12px;border-radius:999px;text-transform:uppercase\"\u003eSecond Edition — August 2026\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0 0 10px;font-size:25px;line-height:1.25;font-weight:700;color:#ffffff\"\u003eKeep your GxP computerised systems under control today. And get ready for the new Annex 11.\u003c\/p\u003e\u003cp style=\"margin:0 0 14px;color:#d7dfeb;font-size:15px\"\u003e175 operational pages + \u003cstrong style=\"color:#ffffff\"\u003e12 ready-to-use Excel and Word tools\u003c\/strong\u003e, with official sources verified on 16 August 2026.\u003c\/p\u003e\u003cp style=\"margin:0\"\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e175 pages\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e24 chapters\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e12 editable tools\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003eIT + EN\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003eLifetime updates\u003c\/span\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin:0 0 26px\"\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e📘\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eThe full guide\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003e175 pages, 24 chapters: from the regulatory framework to decommissioning, with tables, workflows, decision trees and 5 case studies.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e🧰\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eThe operational toolkit\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003e7 Excel workbooks with formulas and dashboards + 5 Word templates with model text: not empty shells — tools set up by a senior QA\/CSV professional.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e🔁\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eLifetime updates\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003eAll future editions included and sent by email — including the dedicated revision when the final Annex 11 is published.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:21px;margin:0 0 6px\"\u003eThe toolkit: 12 ready-to-use tools, included in the price\u003c\/h3\u003e\u003cp style=\"margin:0 0 14px;color:#44506a\"\u003eIt is the part our customers use most. Every file ships with instructions, worked examples, formulas, dropdowns and dashboards: open it and start working.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px;margin:0 0 26px\"\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAnnex 11 Readiness \u0026amp; Gap Assessment\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003ePre-populated on the 20 current-vs-draft comparison areas, with a dashboard: a picture of your gaps in one day.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eGxP Systems Inventory \u0026amp; Criticality\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eInventory and classify your systems: criticality, level of assurance and periodic review due dates calculated by formula.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eCSV\/CSA Risk Assessment\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eFrom risk to strategy: the matrix classifies functions and proposes the testing approach (scripted, unscripted, leveraging).\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eRequirements Traceability Matrix\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eURS → risk → test → evidence, with automatic detection of uncovered requirements.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAccess Review\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eUser and privileged-account review with auto-proposed actions (revoke, justify) and a sign-off summary sheet.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eChange Impact \u0026amp; Revalidation\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eThe decision tree in formulas: 13 guided questions → a reasoned outcome, from no action to major revalidation.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eInspection Readiness Checklist\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003e79 checks across 13 areas with a readiness dashboard: know where you stand before the inspector does.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eValidation Plan Template\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003e15 sections with RACI and pre-written model text for strategy, criteria and deviations: start from 70%, not from a blank page.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eURS Template\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eEmbedded guidance, 10 requirement categories with pre-written examples and the good-vs-poor requirement comparison.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eSupplier Assessment Questionnaire\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003e144 questions in 14 sections (QMS, security, data integrity, cloud…) with a risk-based approach and a final assessment section.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003ePeriodic Review Template\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eThe 17 review areas with data tables, per-area outcome and final decision: audit-ready.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eSystem Decommissioning Plan\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eData strategy, migration verification and the 10 operational steps with owner and evidence for each.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:19px;margin:0 0 10px\"\u003eYou will use it tomorrow morning\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;margin:0 0 26px;font-size:13.5px\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600;width:55%\"\u003eAn inspection announced four weeks from now\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eInspection Readiness Checklist + Ch. 23 “What an Inspector May Ask”\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eA new SaaS to qualify\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eCh. 16 Cloud + Supplier Questionnaire + Risk Assessment\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eA major upgrade of a validated system\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eChange Impact \u0026amp; Revalidation + Ch. 12\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eAn audit trail review to formalise\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eThe Ch. 9 workflow, from frequency to evidence\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eUnderstanding the impact of the draft Annex 11\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eChs. 21–22 (20 comparison areas) + Readiness Gap Assessment\u003c\/td\u003e\u003c\/tr\u003e\u003c\/tbody\u003e\u003c\/table\u003e\u003cdiv style=\"background:#fdf6e3;border-left:4px solid #c9a227;border-radius:6px;padding:14px 16px;margin:0 0 26px\"\u003e\u003cp style=\"margin:0 0 6px;font-weight:700\"\u003eAnnex 11: the guide that separates what is in force from what is coming\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13.5px;color:#44506a\"\u003eEvery statement carries a graphic label — \u003cstrong\u003eCURRENT\u003c\/strong\u003e, \u003cstrong\u003eDRAFT\u003c\/strong\u003e, \u003cstrong\u003eEXPECTED DIRECTION\u003c\/strong\u003e, \u003cstrong\u003eBEST PRACTICE\u003c\/strong\u003e — with official sources verified on 16 August 2026. The draft Annex 11 (consultation closed in October 2025, final text not published) is treated as readiness material: 20 comparison areas, a 6-step assessment method and a roadmap, without ever presenting it as a requirement already in force.\u003c\/p\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:19px;margin:0 0 8px\"\u003eInside the guide\u003c\/h3\u003e\u003cul style=\"margin:0 0 20px;padding-left:20px;font-size:14px;color:#2a3550\"\u003e\u003cli\u003e\u003cstrong\u003eFoundations:\u003c\/strong\u003e governance and RACI, system inventory, classification and level of assurance, QRM per ICH Q9(R1) with a worked FMEA\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eAssurance:\u003c\/strong\u003e CSV → risk-based CSV → CSA (final FDA guidance Feb 2026, with its actual scope), the full lifecycle, interfaces and data migration\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eOperational controls:\u003c\/strong\u003e data integrity with compliant\/weak\/finding examples, audit trail, access and security, backup\/BCP\/DR, change management with a decision tree, periodic review, decommissioning\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eTechnology:\u003c\/strong\u003e suppliers and cloud (validated state under frequent releases), Agile\/DevOps, low-code and GxP spreadsheets, e-records \u0026amp; signatures (Annex 11 vs Part 11 table), AI\/ML and draft Annex 22\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eInspection readiness:\u003c\/strong\u003e realistic inspection questions for 12 areas with expected evidence and red flags + 5 full case studies\u003c\/li\u003e\u003c\/ul\u003e\u003cdiv style=\"margin:0 0 26px\"\u003e\u003cp style=\"margin:0 0 10px;font-weight:700;font-size:16px\"\u003eDownload a free preview — 18 pages of real content, including three Annex 11 comparison sheets\u003c\/p\u003e\u003cp style=\"margin:0\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_CSV_GxP_Preview_2ed_ENG.pdf?v=1786950135\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#14243a;color:#ffffff;font-weight:700;font-size:14px;padding:12px 22px;border-radius:8px;text-decoration:none;margin:0 10px 10px 0\"\u003e⬇ Preview ENG (PDF)\u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_CSV_GxP_Preview_2ed_ITA.pdf?v=1786950135\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#ffffff;color:#14243a;font-weight:700;font-size:14px;padding:11px 21px;border-radius:8px;text-decoration:none;border:2px solid #14243a;margin:0 0 10px\"\u003e⬇ Preview ITA (PDF)\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003ctable style=\"width:100%;border-collapse:collapse;margin:0 0 18px;font-size:13.5px\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600;width:30%\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eProfessional A4 PDF, 175 pages + toolkit as editable Excel\/Word files\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eEdition\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eSecond — August 2026 (v2.0) · sources verified on 16 August 2026\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eLanguages\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eItalian and English — pick your variant above (the toolkit ships in the variant language)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eUpdates\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eAll future releases included for life, by email · dedicated revision upon publication of the final Annex 11\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eDelivery\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eInstant digital download after payment\u003c\/td\u003e\u003c\/tr\u003e\u003c\/tbody\u003e\u003c\/table\u003e\u003cp style=\"margin:0 0 18px;font-size:13.5px;color:#44506a\"\u003e\u003cstrong\u003eWho it is for:\u003c\/strong\u003e QA Managers, CSV\/CSA Managers, Validation Managers, IT Quality, Data Integrity Managers, System Owners, Process Owners, IT, Regulatory Affairs, QPs, auditors and GxP consultants.\u003c\/p\u003e\u003cp style=\"margin:0;font-size:11.5px;color:#8892a6\"\u003eGuideGxP is an independent publisher, not affiliated with the regulatory authorities cited. The guide does not replace official regulations: it systematically distinguishes between current requirements and draft proposals; content relating to documents not yet final is provided solely to support readiness assessment.\u003c\/p\u003e\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ENG - English","offer_id":53688676614474,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53688676647242,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/guidetocsv_august2026.png?v=1786951358"},{"product_id":"computer-software-assurance-csa-guida-operativa-gxp","title":"Computer Software Assurance (CSA) – Operational GxP Guide","description":"\u003cp data-start=\"63\" data-end=\"238\"\u003eComputer Software Assurance (CSA) is the risk-based approach promoted by the FDA for the validation of GxP software, based on the principle \u003cstrong data-start=\"203\" data-end=\"238\"\u003e“Assurance over Documentation.”\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"240\" data-end=\"474\"\u003eThis operational guide shows how to apply CSA in a practical way, moving beyond the traditional CSV model and transforming regulatory requirements into operational activities, risk-proportionate testing, and audit-ready documentation.\u003c\/p\u003e\n\u003ch2 data-start=\"476\" data-end=\"511\"\u003e\u003cstrong data-start=\"476\" data-end=\"511\"\u003eWhat you will find in the guide\u003c\/strong\u003e\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli data-start=\"514\" data-end=\"572\"\u003eCSA regulatory framework (FDA, Annex 11, GAMP 5, ICH Q9)\u003c\/li\u003e\n\u003cli data-start=\"575\" data-end=\"620\"\u003eDifferences between traditional CSV and CSA\u003c\/li\u003e\n\u003cli data-start=\"623\" data-end=\"673\"\u003eRisk assessment and functionality classification\u003c\/li\u003e\n\u003cli data-start=\"676\" data-end=\"727\"\u003eScripted and exploratory testing in line with CSA\u003c\/li\u003e\n\u003cli data-start=\"730\" data-end=\"771\"\u003eEvidence management and audit readiness\u003c\/li\u003e\n\u003cli data-start=\"774\" data-end=\"813\"\u003eApplication to Cloud and SaaS systems\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"815\" data-end=\"902\"\u003e\u003cstrong data-start=\"815\" data-end=\"834\"\u003eTarget audience\u003c\/strong\u003e\u003cbr data-start=\"834\" data-end=\"837\"\u003eQA, CSV\/CSA Managers, IT, Validation, Regulatory Affairs, and QP.\u003c\/p\u003e\n\u003ch2 data-start=\"904\" data-end=\"923\"\u003e\u003cstrong data-start=\"904\" data-end=\"923\"\u003eProduct details\u003c\/strong\u003e\u003c\/h2\u003e\n\u003cp data-start=\"926\" data-end=\"952\"\u003eFormat: Professional PDF\u003c\/p\u003e\n\u003cp data-start=\"955\" data-end=\"973\"\u003ePages: 120 pages\u003c\/p\u003e\n\u003cp data-start=\"976\" data-end=\"1002\"\u003eUpdated to: January 2026\u003c\/p\u003e\n\u003cp data-start=\"1005\" data-end=\"1027\"\u003eLanguages: ITA – ENG\u003c\/p\u003e\n\u003cp data-start=\"1029\" data-end=\"1120\"\u003e\u003cstrong data-start=\"1029\" data-end=\"1064\"\u003eDOWNLOAD A PREVIEW OF THE GUIDE\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable 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;\" 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\u0026nbsp;\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\/34-computer-software-assurance.png?v=1784929359"},{"product_id":"saas-cloud-validation-guida-gxp-toolkit","title":"SaaS \u0026 Cloud Validation: GxP Implementation Guide + Templates","description":"\u003ch2 data-path-to-node=\"4\"\u003e\u003cb data-path-to-node=\"4\" data-index-in-node=\"62\"\u003eValidate the Cloud stress-free. The ultimate operational guide for the Pharma world.\u003c\/b\u003e\u003c\/h2\u003e\n\u003cp data-path-to-node=\"6\"\u003eThe adoption of Cloud and SaaS in the Life Science sector is no longer the future—it is the present. But how do you reconcile innovation and agility with strict\u0026nbsp;\u003cb data-path-to-node=\"6\" data-index-in-node=\"161\"\u003eFDA 21 CFR Part 11\u003c\/b\u003e and \u003cb data-path-to-node=\"6\" data-index-in-node=\"184\"\u003eEU GMP Annex 11\u003c\/b\u003e requirements?\u003c\/p\u003e\n\u003cp data-path-to-node=\"7\"\u003eThis guide is not the usual theoretical manual. It is a \u003cb data-path-to-node=\"7\" data-index-in-node=\"56\"\u003epractical working tool\u003c\/b\u003e, designed for QA Managers, IT Specialists, and Validation Experts who need to implement, validate, and maintain cloud systems in compliance with GxP.\u003c\/p\u003e\n\u003cp data-path-to-node=\"8\"\u003eUpdated to \u003cb data-path-to-node=\"8\" data-index-in-node=\"11\"\u003eGAMP 5 Second Edition\u003c\/b\u003e principles and \u003cb data-path-to-node=\"8\" data-index-in-node=\"48\"\u003eCSA (Computer Software Assurance)\u003c\/b\u003e logic, this guide takes you step-by-step from validation strategy all the way to inspection preparation.\u003c\/p\u003e\n\u003ch3 data-path-to-node=\"9\"\u003e\u003cb data-path-to-node=\"9\" data-index-in-node=\"0\"\u003eWhat You Will Learn\u003c\/b\u003e\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli data-path-to-node=\"10,0,0\"\u003e\u003cb data-path-to-node=\"10,0,0\" data-index-in-node=\"0\"\u003eCloud Strategy:\u003c\/b\u003e How to manage IaaS, PaaS, and SaaS models and the \"Shared Responsibility Model.\"\u003c\/li\u003e\n\u003cli data-path-to-node=\"10,1,0\"\u003e\u003cb data-path-to-node=\"10,1,0\" data-index-in-node=\"0\"\u003eRegulations Explained:\u003c\/b\u003e Essential requirements of FDA Part 11, Annex 11, and Data Integrity (ALCOA+) translated into practical actions.\u003c\/li\u003e\n\u003cli data-path-to-node=\"10,2,0\"\u003e\u003cb data-path-to-node=\"10,2,0\" data-index-in-node=\"0\"\u003eVendor Management:\u003c\/b\u003e How to audit and qualify Cloud vendors (even giants like AWS\/Azure).\u003c\/li\u003e\n\u003cli data-path-to-node=\"10,3,0\"\u003e\u003cb data-path-to-node=\"10,3,0\" data-index-in-node=\"0\"\u003eLifecycle:\u003c\/b\u003e From URS to Go-Live, moving through Risk Assessment and optimized Testing (IQ\/OQ\/PQ).\u003c\/li\u003e\n\u003cli data-path-to-node=\"10,4,0\"\u003e\u003cb data-path-to-node=\"10,4,0\" data-index-in-node=\"0\"\u003eAudit Readiness:\u003c\/b\u003e How to present a SaaS system to an inspector and avoid common observations.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-path-to-node=\"12\"\u003e\u003cb data-path-to-node=\"12\" data-index-in-node=\"0\"\u003e📦 BONUS INCLUDED: The Operational Toolkit\u003c\/b\u003e\u003c\/p\u003e\n\u003cp data-path-to-node=\"13\"\u003eInside the guide, you will find \u003cb data-path-to-node=\"13\" data-index-in-node=\"32\"\u003e7 Checklists and 9 Ready-to-Use Templates\u003c\/b\u003e to make your system \"Audit-Ready\" immediately:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-path-to-node=\"14,0,0\"\u003e✅ \u003cb data-path-to-node=\"14,0,0\" data-index-in-node=\"2\"\u003eChecklists:\u003c\/b\u003e Vendor Assessment, Part 11\/Annex 11 Assessment, Data Integrity Check, Audit Prep, and more.\u003c\/li\u003e\n\u003cli data-path-to-node=\"14,1,0\"\u003e📝 \u003cb data-path-to-node=\"14,1,0\" data-index-in-node=\"3\"\u003eTemplates:\u003c\/b\u003e Validation Plan, URS, Traceability Matrix, IQ\/OQ\/PQ Protocols and Reports, Change Control Register, and more.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-path-to-node=\"15\"\u003e\u003cb data-path-to-node=\"15\" data-index-in-node=\"0\"\u003eProduct Details\u003c\/b\u003e\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli data-path-to-node=\"16,0,0\"\u003e\u003cb data-path-to-node=\"16,0,0\" data-index-in-node=\"0\"\u003eFormat:\u003c\/b\u003e Professional PDF\u003c\/li\u003e\n\u003cli data-path-to-node=\"16,1,0\"\u003e\u003cb data-path-to-node=\"16,1,0\" data-index-in-node=\"0\"\u003ePages:\u003c\/b\u003e 188 pages\u003c\/li\u003e\n\u003cli data-path-to-node=\"16,2,0\"\u003e\u003cb data-path-to-node=\"16,2,0\" data-index-in-node=\"0\"\u003eUpdated:\u003c\/b\u003e January 2026\u003c\/li\u003e\n\u003cli data-path-to-node=\"16,3,0\"\u003e\u003cb data-path-to-node=\"16,3,0\" data-index-in-node=\"0\"\u003eLanguages:\u003c\/b\u003e ITA - ENG\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-path-to-node=\"19\"\u003e\u003cb data-path-to-node=\"19\" data-index-in-node=\"0\"\u003eDOWNLOAD A PREVIEW OF THE GUIDE\u003c\/b\u003e\u003c\/p\u003e\n\u003ctable 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;\" 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 rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/SaaS_Cloud_Validation_guida_GxP_ITA_PREVIEW.pdf?v=1768062879\" 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 rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/SaaS_Cloud_Validation_A_Guide_to_GxP_ENG_PREVIEW.pdf?v=1768062914\" target=\"_blank\"\u003ePreview ENG\u003c\/a\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\"\u003e\u0026nbsp;\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":53765578588490,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53765578621258,"sku":null,"price":99.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/11-saas-cloud-validation.png?v=1784928495"},{"product_id":"guida-ai-gmp-annex-22-readiness","title":"Operational Guide to Artificial Intelligence in GMP Environments — Annex 22 Readiness","description":"\u003cdiv\u003e\u003cdiv style=\"background:#14243a;border-radius:12px;padding:28px 24px;color:#ffffff;margin:0 0 22px\"\u003e\u003cp style=\"margin:0 0 12px\"\u003e\u003cspan style=\"background:#c9a227;color:#14243a;font-weight:700;font-size:12px;letter-spacing:1px;padding:4px 12px;border-radius:999px;text-transform:uppercase\"\u003eFirst Edition — August 2026\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0 0 10px;font-size:25px;line-height:1.25;font-weight:700;color:#ffffff\"\u003eAI is already inside your GMP processes. Govern it before an inspector asks.\u003c\/p\u003e\u003cp style=\"margin:0 0 14px;color:#d7dfeb;font-size:15px\"\u003eThe first operational guide with a toolkit on Artificial Intelligence in GMP environments: how to inventory, classify, validate and keep AI\/ML components under control today — under the current Annex 11 — and how to prepare for the new \u003cstrong style=\"color:#ffffff\"\u003eAnnex 22\u003c\/strong\u003e without chasing the draft. Official sources verified on 17 August 2026.\u003c\/p\u003e\u003cp style=\"margin:0\"\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e13 chapters + 3 appendices\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e6 editable tools\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003eIT + EN\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003e3 case studies\u003c\/span\u003e\u003cspan style=\"display:inline-block;background:#22344e;color:#e8edf5;font-size:12px;padding:4px 10px;border-radius:6px;margin:0 6px 6px 0\"\u003eLifetime updates\u003c\/span\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin:0 0 26px\"\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e🧠\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eThe complete framework\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003eFrom the inventory of AI\/ML components to drift monitoring in operation: classification decision tree, intended use, acceptance criteria, test data independency, explainability, suppliers.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e🧰\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eThe operational toolkit\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003e3 Excel workbooks with formulas (the calculated decision tree, the gap assessment pre-populated on the draft, the metrics matrix with PASS\/FAIL) + 3 Word templates with worked examples.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 200px;background:#f6f8fb;border:1px solid #e3e9f2;border-radius:10px;padding:16px\"\u003e\u003cp style=\"margin:0;font-size:26px\"\u003e🔁\u003c\/p\u003e\u003cp style=\"margin:6px 0 4px;font-weight:700\"\u003eLifetime updates\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13px;color:#44506a\"\u003eWhen the final Annex 22 is published, you automatically receive the updated revision by email. Buy once, stay aligned.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:21px;margin:0 0 6px\"\u003eThe toolkit: 6 ready-to-use tools, included in the price\u003c\/h3\u003e\u003cp style=\"margin:0 0 14px;color:#44506a\"\u003eNot empty shells: every file contains instructions, worked examples consistent with the guide's chapters, formulas and dashboards.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px;margin:0 0 26px\"\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAI System Inventory \u0026amp; Applicability\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eInventory your AI\/ML components: the decision tree in formulas returns the classification outcome (A\/B\/C\/D) for each system, with a dashboard.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAnnex 22 Readiness \u0026amp; Gap Assessment\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003e30 expectations pre-populated from the draft's 10 chapters, with gaps, risk, actions and a progress dashboard. A picture of your readiness in one day.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #1d6f42;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#1d6f42;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eEXCEL\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAI Risk \u0026amp; Acceptance Criteria Matrix\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eFrom the harm of a false negative to the right metric: thresholds, baseline, subgroups, formula-driven PASS\/FAIL and a confusion matrix helper.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eIntended Use \u0026amp; AI System Description\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eThe founding document of every GMP AI system: input space, limits, subgroups, the role of the human — with a worked visual inspection example.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAI Test Plan Template\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003eDataset, representativeness, independency with an anti-leakage checklist, execution protocol, explainability and confidence, iteration management.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#ffffff;border:1px solid #e3e9f2;border-left:4px solid #185abd;border-radius:8px;padding:12px 14px\"\u003e\u003cp style=\"margin:0 0 4px\"\u003e\u003cspan style=\"background:#185abd;color:#fff;font-size:10px;font-weight:700;padding:2px 8px;border-radius:4px\"\u003eWORD\u003c\/span\u003e\u003c\/p\u003e\u003cp style=\"margin:0;font-weight:700;font-size:14px\"\u003eAI Supplier Assessment Questionnaire\u003c\/p\u003e\u003cp style=\"margin:3px 0 0;font-size:12.5px;color:#44506a\"\u003e46 questions in 8 sections for the vendor selling (or switching on) your AI: training data, versioning, metrics, use of your data, audit support.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:19px;margin:0 0 10px\"\u003eYou will use it tomorrow morning\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;margin:0 0 26px;font-size:13.5px\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600;width:55%\"\u003e\"Do we have AI in our systems?\" — nobody can answer\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eAI System Inventory + the Chapter 4 decision tree\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eA new vision\/ML system to validate\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eIntended Use + Risk \u0026amp; Acceptance Matrix + AI Test Plan (Chs. 5–8)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eYour vendor announces an AI feature in the next upgrade\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eAI Supplier Questionnaire + Ch. 10\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eThe team wants an LLM assistant on SOPs\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eOutcome C classification + case study CS3 + human-in-the-loop\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px;background:#f6f8fb;font-weight:600\"\u003eUnderstanding how far you are from the draft Annex 22\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:9px 12px\"\u003eCh. 11 (6-step method) + Readiness Gap Assessment + roadmap\u003c\/td\u003e\u003c\/tr\u003e\u003c\/tbody\u003e\u003c\/table\u003e\u003cdiv style=\"background:#fdf6e3;border-left:4px solid #c9a227;border-radius:6px;padding:14px 16px;margin:0 0 26px\"\u003e\u003cp style=\"margin:0 0 6px;font-weight:700\"\u003eRigour, not hype: a draft is a draft\u003c\/p\u003e\u003cp style=\"margin:0;font-size:13.5px;color:#44506a\"\u003eAnnex 22 was released for consultation on 7 July 2025; the consultation closed in October 2025 and no final text has been published (the exclusions on dynamic, probabilistic and generative AI are under review after the EMA workshop of June–July 2026). This guide labels every statement — \u003cstrong\u003eCURRENT\u003c\/strong\u003e, \u003cstrong\u003eDRAFT\u003c\/strong\u003e, \u003cstrong\u003eEXPECTED DIRECTION\u003c\/strong\u003e, \u003cstrong\u003eBEST PRACTICE\u003c\/strong\u003e — and uses the draft for readiness only: today's compliance baseline remains Annex 11, and the guide shows you how to apply it to AI systems now.\u003c\/p\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:19px;margin:0 0 8px\"\u003eInside the guide\u003c\/h3\u003e\u003cul style=\"margin:0 0 20px;padding-left:20px;font-size:14px;color:#2a3550\"\u003e\u003cli\u003e\u003cstrong\u003eFramework and principles:\u003c\/strong\u003e AI in GMP processes without the hype (vision, EM trending, predictive maintenance, LLMs), the exact regulatory status as of 17 August 2026, roles and RACI — including the data scientist as a role to govern\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eThe operational framework:\u003c\/strong\u003e classification decision tree (static\/dynamic, deterministic\/probabilistic, critical\/non-critical), verifiable intended use, metrics and acceptance criteria with the confusion matrix explained on real numbers, test data independency and anti-leakage, explainability and confidence, drift monitoring and retraining as change control, purchased AI and suppliers\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eReadiness in practice:\u003c\/strong\u003e Annex 22 readiness assessment in 6 steps with a worked example and roadmap, 3 full case studies (visual inspection, EM anomaly detection, LLM assistant), \"What an Inspector May Ask — AI edition\" across 8 areas\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eAppendices:\u003c\/strong\u003e source register with URLs and verification date, 40-entry AI-GxP glossary, toolkit overview\u003c\/li\u003e\u003c\/ul\u003e\u003cdiv style=\"margin:0 0 26px\"\u003e\u003cp style=\"margin:0 0 10px;font-weight:700;font-size:16px\"\u003eDownload a free preview — 16 pages of real content, including the classification decision tree\u003c\/p\u003e\u003cp style=\"margin:0\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_AI_GMP_Annex22_Preview_1ed_ENG.pdf?v=1786971038\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#14243a;color:#ffffff;font-weight:700;font-size:14px;padding:12px 22px;border-radius:8px;text-decoration:none;margin:0 10px 10px 0\"\u003e⬇ Preview ENG (PDF)\u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_AI_GMP_Annex22_Preview_1ed_ITA.pdf?v=1786971038\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#ffffff;color:#14243a;font-weight:700;font-size:14px;padding:11px 21px;border-radius:8px;text-decoration:none;border:2px solid #14243a;margin:0 0 10px\"\u003e⬇ Preview ITA (PDF)\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003ctable style=\"width:100%;border-collapse:collapse;margin:0 0 18px;font-size:13.5px\"\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600;width:30%\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eProfessional A4 PDF (71 pages IT \/ 73 pages EN) + toolkit as editable Excel\/Word files\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eEdition\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eFirst — August 2026 (v1.0) · official sources verified on 17 August 2026\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eLanguages\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eItalian and English — pick your variant above (the toolkit ships in the variant language)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eUpdates\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eAll future releases included for life, by email · dedicated revision upon publication of the final Annex 22\u003c\/td\u003e\u003c\/tr\u003e\u003ctr\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px;background:#f6f8fb;font-weight:600\"\u003eDelivery\u003c\/td\u003e\u003ctd style=\"border:1px solid #e3e9f2;padding:8px 12px\"\u003eInstant digital download after payment\u003c\/td\u003e\u003c\/tr\u003e\u003c\/tbody\u003e\u003c\/table\u003e\u003cp style=\"margin:0 0 18px;font-size:13.5px;color:#44506a\"\u003e\u003cstrong\u003eWho it is for:\u003c\/strong\u003e QA Managers, CSV\/CSA and Digital Quality Managers, IT Quality, Data Integrity Managers, System Owners, Process Owners, IT, data teams in regulated environments, Regulatory Affairs, QPs, auditors and GxP consultants.\u003c\/p\u003e\u003cp style=\"margin:0;font-size:11.5px;color:#8892a6\"\u003eGuideGxP is an independent publisher, not affiliated with the regulatory authorities cited. The guide does not replace official regulations: it systematically distinguishes between current requirements and draft proposals; content relating to documents not yet final — including the draft Annex 22 — is provided solely to support readiness assessment and must not be read as requirements already in force.\u003c\/p\u003e\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":62976563478858,"sku":null,"price":149.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":62976563511626,"sku":null,"price":149.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/01_GuideGxP_AI_GMP_Cover.png?v=1786970481"}],"url":"https:\/\/www.guidegxp.com\/collections\/ai-e-sistemi-computerizzati-gxp.oembed","provider":"GuideGxP","version":"1.0","type":"link"}