Second Edition — August 2026
Keep your GxP computerised systems under control today. And get ready for the new Annex 11.
175 operational pages + 12 ready-to-use Excel and Word tools, with official sources verified on 16 August 2026.
175 pages24 chapters12 editable toolsIT + ENLifetime updates
📘
The full guide
175 pages, 24 chapters: from the regulatory framework to decommissioning, with tables, workflows, decision trees and 5 case studies.
🧰
The operational toolkit
7 Excel workbooks with formulas and dashboards + 5 Word templates with model text: not empty shells — tools set up by a senior QA/CSV professional.
🔁
Lifetime updates
All future editions included and sent by email — including the dedicated revision when the final Annex 11 is published.
The toolkit: 12 ready-to-use tools, included in the price
It is the part our customers use most. Every file ships with instructions, worked examples, formulas, dropdowns and dashboards: open it and start working.
EXCEL
Annex 11 Readiness & Gap Assessment
Pre-populated on the 20 current-vs-draft comparison areas, with a dashboard: a picture of your gaps in one day.
EXCEL
GxP Systems Inventory & Criticality
Inventory and classify your systems: criticality, level of assurance and periodic review due dates calculated by formula.
EXCEL
CSV/CSA Risk Assessment
From risk to strategy: the matrix classifies functions and proposes the testing approach (scripted, unscripted, leveraging).
EXCEL
Requirements Traceability Matrix
URS → risk → test → evidence, with automatic detection of uncovered requirements.
EXCEL
Access Review
User and privileged-account review with auto-proposed actions (revoke, justify) and a sign-off summary sheet.
EXCEL
Change Impact & Revalidation
The decision tree in formulas: 13 guided questions → a reasoned outcome, from no action to major revalidation.
EXCEL
Inspection Readiness Checklist
79 checks across 13 areas with a readiness dashboard: know where you stand before the inspector does.
WORD
Validation Plan Template
15 sections with RACI and pre-written model text for strategy, criteria and deviations: start from 70%, not from a blank page.
WORD
URS Template
Embedded guidance, 10 requirement categories with pre-written examples and the good-vs-poor requirement comparison.
WORD
Supplier Assessment Questionnaire
144 questions in 14 sections (QMS, security, data integrity, cloud…) with a risk-based approach and a final assessment section.
WORD
Periodic Review Template
The 17 review areas with data tables, per-area outcome and final decision: audit-ready.
WORD
System Decommissioning Plan
Data strategy, migration verification and the 10 operational steps with owner and evidence for each.
You will use it tomorrow morning
| An inspection announced four weeks from now | Inspection Readiness Checklist + Ch. 23 “What an Inspector May Ask” |
| A new SaaS to qualify | Ch. 16 Cloud + Supplier Questionnaire + Risk Assessment |
| A major upgrade of a validated system | Change Impact & Revalidation + Ch. 12 |
| An audit trail review to formalise | The Ch. 9 workflow, from frequency to evidence |
| Understanding the impact of the draft Annex 11 | Chs. 21–22 (20 comparison areas) + Readiness Gap Assessment |
Annex 11: the guide that separates what is in force from what is coming
Every statement carries a graphic label — CURRENT, DRAFT, EXPECTED DIRECTION, BEST PRACTICE — 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.
Inside the guide
- Foundations: governance and RACI, system inventory, classification and level of assurance, QRM per ICH Q9(R1) with a worked FMEA
- Assurance: CSV → risk-based CSV → CSA (final FDA guidance Feb 2026, with its actual scope), the full lifecycle, interfaces and data migration
- Operational controls: data integrity with compliant/weak/finding examples, audit trail, access and security, backup/BCP/DR, change management with a decision tree, periodic review, decommissioning
- Technology: suppliers and cloud (validated state under frequent releases), Agile/DevOps, low-code and GxP spreadsheets, e-records & signatures (Annex 11 vs Part 11 table), AI/ML and draft Annex 22
- Inspection readiness: realistic inspection questions for 12 areas with expected evidence and red flags + 5 full case studies
| Format | Professional A4 PDF, 175 pages + toolkit as editable Excel/Word files |
| Edition | Second — August 2026 (v2.0) · sources verified on 16 August 2026 |
| Languages | Italian and English — pick your variant above (the toolkit ships in the variant language) |
| Updates | All future releases included for life, by email · dedicated revision upon publication of the final Annex 11 |
| Delivery | Instant digital download after payment |
Who it is for: QA Managers, CSV/CSA Managers, Validation Managers, IT Quality, Data Integrity Managers, System Owners, Process Owners, IT, Regulatory Affairs, QPs, auditors and GxP consultants.
GuideGxP 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.
