EU GMP Annex 11
Computerised systems under EU GMP Annex 11 — the European counterpart to Part 11 for manufacturing. For clinical trials, inspectors refer to the EMA 2023 guideline on computerised systems and electronic data in clinical trials. Validation is for the intended use in your environment: a supplier's validation pack is evidence, never a substitute.
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Read the article →A document appears here because it names EU GMP Annex 11 in its own text. Nothing is inferred: this is what we have actually written about it.