# Module 4 pinpoint verification — 6 November 2026
These are source checks and teaching interpretations, not consultant approval.

| Official document and printed page | Verified clauses | Meaning relevant to this module (paraphrased) |
|---|---|---|
| [Annex 11, page 3](https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf) | 4.3 | Maintain the relevant-system inventory; critical-system descriptions include arrangements, flows, interfaces, prerequisites and security. A version screenshot alone is insufficient. |
| Same Annex 11 page | 4.7 | Demonstrate suitable methods and scenarios, considering parameter/data limits and error handling; assess automated test tools/environments. IQ identity is distinct from functional validation. |
| [Chapter 3, page 5](https://health.ec.europa.eu/document/download/18d76565-137b-41d2-a602-794527f708c1_en?filename=chapter_3.pdf) | 3.37–3.38 | Cleaning equipment should not introduce contamination; installation should prevent error and contamination risks. |
| Same Chapter 3 page | 3.39 | Product-contact materials must not adversely affect product quality through reaction, addition or absorption. |
| Same Chapter 3 page | 3.40–3.41 | Measuring equipment needs appropriate range/precision, defined calibration/check intervals and methods, with records. |
| [Chapter 4, pages 3–4](https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf) | 4.3–4.5 | Authorized approval, signatures/dates and effective dates for identifiable instructions; orderly, checkable presentation; regular review and currency. |
| Same Chapter 4, page 4 | 4.10, 4.12 | Identify record relationships/locations and protect integrity throughout retention. Other-document retention depends on the supported activity. Critical raw data supporting a marketing authorization normally remain while it is in force, subject to the clause's documented supersession provisions. No universal IQ retention period is taught. |

The dry OQ example is an original practical recommendation applying Annex 15 §2.10, not a prescribed regulatory activity. The clause addresses conditional approval for the next qualification stage with a documented no-significant-impact assessment. Site authorization remains mandatory.