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According to EU GMP Annex 11, what is the fundamental requirement for computerised systems used in GMP-regulated activities?

Knowledge QAEu Annex11easy

Question

According to EU GMP Annex 11, what is the fundamental requirement for computerised systems used in GMP-regulated activities?

Choices

A. They must use a specific approved operating system
B. They should be validated, and the extent of validation should be based on a documented risk assessment
C. They only need to be validated if they generate electronic signatures
D. Validation is only required for systems purchased after 2011

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
Gemini 3.1 Flash-Lite	100.0%	1.1s	88	100
GPT-5.4 mini	100.0%	928ms	90	61
GPT-5.4 nano	100.0%	834ms	90	70
Claude Haiku 4.5	100.0%	3.5s	97	297
Claude Sonnet 4.6	100.0%	9.4s	97	376
Llama 4 Scout	100.0%	1.2s	95	322
Claude Opus 4.6	100.0%	10.1s	97	395
Llama 4 Maverick	100.0%	10.4s	96	396
Llama 3.3 70B Instruct	100.0%	8.6s	97	186
Mistral Small 2603	100.0%	1.2s	104	207
Qwen3.5-397B-A17B	100.0%	6.8s	100	835
DeepSeek-V3.2	100.0%	10.6s	89	129
DeepSeek-R1	100.0%	15.1s	95	558
DeepSeek-R1-Distill-Qwen-32B	100.0%	30.3s	92	478
Mistral Large 3 675B	100.0%	5.2s	92	360
GPT-5.4	100.0%	1.1s	90	52
Gemini 3.1 Pro	100.0%	14.5s	88	865
Gemini 3 Flash	100.0%	8.1s	88	268
Qwen3.5-35B-A3B	0.0%	7.0s	100	1,190

Tags

validationrisk_assessmentcomputerised_systems