# Module 4 source and technical review map
Official EudraLex index checked 6 November 2026: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
The index links Annex 15 operational 1 October 2015, Chapter 3 operational 1 March 2015, Chapter 4 January 2011 and Annex 11 January 2011. Consultation drafts are not treated as operative requirements. Scope here is human medicinal products.

| Lesson | Verified reference | Teaching application |
|---|---|---|
|4.1|Annex 15 §§3.8–3.10, IQ glossary|Installed configuration; distinct qualification questions|
|4.2|Annex 15 §§1.2, 2.2–2.6, 3.9(ii); Chapter 4 §§4.3–4.5|Controlled protocol, criteria and baseline|
|4.3|Annex 15 §3.9(i–ii); Chapter 3 §§3.34–3.38|Physical walkdown and maintenance access|
|4.4|Annex 15 §3.9(v); Chapter 3 §3.39|Installed materials versus material suitability|
|4.5|Annex 15 §3.9(i), §8.1; Chapter 3 §3.42|Connections, labels and separate utility evidence|
|4.6|Annex 15 §3.9(iv); Chapter 3 §§3.40–3.41|Calibration applicability, not sticker-only review|
|4.7|Annex 15 §§2.6, 3.6, 3.9(iii); Annex 11 §§4.3, 4.7|Supplier instructions, justified reuse, configuration baseline|
|4.8|Chapter 4 §§4.7–4.10, 4.12|Contemporaneous attributable observations and traceable corrections and original-data retention|
|4.9|Annex 15 §§2.7–2.10, 11|Discrepancy, correction/change, verification, conditional progression|
|4.10|Annex 15 §§2.9–2.10, 3.10–3.12|Bounded report and OQ handover|

Official documents:
- Annex 15: https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en
- Chapter 3: https://health.ec.europa.eu/document/download/18d76565-137b-41d2-a602-794527f708c1_en?filename=chapter_3.pdf
- Chapter 4: https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf
- Annex 11: https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf

The examples, checklist fields, model reasoning, safe-access reminders and visual layouts are original teaching recommendations, not verbatim regulatory requirements or universal templates. The error example computes 40.4−40.0=+0.4 °C and explicitly excludes a complete uncertainty/decision-rule assessment. 9/10=90% is coverage only. No universal clearance, material grade or utility-quality limit is prescribed. Training records are fictional and blank templates must not be mistaken for approved protocols.

Detailed F8 checks: [PINPOINT-VERIFICATION.md](PINPOINT-VERIFICATION.md).