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annex11-001

GMP KnowledgeEu Annex11easy
Question

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

Choices

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

Cross-Model Comparison

ModelScoreLatencyTokens InTokens Out
GLM-5.3N/AN/A--
MiniMax M3N/AN/A--
Hy4 PreviewN/AN/A--
Muse Glimmer 30BN/AN/A--
Qwen3.8 Max (2.4T-A95B)N/AN/A--
Qwen3.8-FlashN/AN/A--
Claude Opus 4.6100.0%10.1s97395
Llama 4 Maverick100.0%10.4s96396
Llama 3.3 70B Instruct100.0%8.6s97186
Mistral Small 2603100.0%1.2s104207
Qwen3.5-397B-A17B100.0%6.8s100835
DeepSeek-V3.2100.0%10.6s89129
DeepSeek V4 Flash100.0%2.2s22879
DeepSeek-R1100.0%15.1s95558
DeepSeek-R1-Distill-Qwen-32B100.0%30.3s92478
Mistral Large 3 675B100.0%5.2s92360
Gemini 3.1 Pro100.0%14.5s88865
Gemini 3 Flash100.0%8.1s88268
Gemini 3.1 Flash-Lite100.0%1.1s88100
Qwen3.6 27B100.0%9.8s100896
Qwen3.6 35B A3B100.0%5.6s1001,006
DeepSeek V4 Pro100.0%10.4s89500
DeepSeek-V3.2100.0%3.9s9589
DeepSeek V4 Flash100.0%1.9s89239
Gemma 4 26B A4B IT100.0%4.3s101230
Gemma 4 31B IT100.0%4.3s101231
MiniMax M2.7100.0%2.7s126385
Llama 4 Maverick100.0%5.9s153301
Claude Opus 4.8100.0%7.0s129476
GLM-5.2100.0%4.3s98298
Llama 4 Scout100.0%8.6s153313
Llama 3.3 70B Instruct100.0%19.7s156308
Mistral Small 2603100.0%2.4s167327
Mistral Large 3 675B100.0%3.3s155240
Qwen3.5-35B-A3B100.0%7.0s1621,064
Qwen3.6 27B100.0%18.7s162615
Hy4 Preview100.0%16.8s1661,080
Qwen3.6 35B A3B100.0%46.7s1621,147
Qwen3.5-397B-A17B100.0%13.1s162937
DeepSeek V4 Pro100.0%5.0s149300
DeepSeek-V3.2100.0%3.1s14964
Gemma 4 26B A4B IT100.0%4.0s163248
DeepSeek-R1100.0%75.1s1481,052
Gemma 4 26B A4B IT100.0%4.8s163215
Gemma 4 31B IT100.0%6.3s163179
GLM-5.2100.0%4.6s158200
MiniMax M2.7100.0%3.5s184260
Muse Glimmer 30B100.0%3.2s199265
Qwen3.8 27B100.0%3.5s204121
Kimi K3100.0%14.0s231422
GLM-5.3-Flash100.0%4.3s158118
GPT-5.6 Luna100.0%1.3s14871
GPT-5.4 mini100.0%928ms9061
GPT-5.4 nano100.0%834ms9070
Claude Haiku 4.5100.0%3.5s97297
Claude Sonnet 4.6100.0%9.4s97376
Llama 4 Scout100.0%1.2s95322
GPT-5.4100.0%1.1s9052
Qwen3.8 Max (2.4T-A95B)100.0%1.1s20468
Qwen3.8-Flash100.0%4.8s213105
MiniMax M3100.0%4.1s319281
GPT-5.6 Sol100.0%1.5s14842
GLM-5.3100.0%4.6s158351
Claude Opus 5100.0%5.0s217275
Claude Sonnet 5100.0%1.2s2179
Claude Haiku 4.5100.0%9.4s161318
GPT-5.6 Terra100.0%2.0s14847
Qwen3.5-35B-A3B0.0%7.0s1001,190

Tags

validationrisk_assessmentcomputerised_systems