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According to EU GMP Annex 11, what specific requirements apply to data storage and archiving for computerised systems?

Knowledge QAEu Annex11hard
Question

According to EU GMP Annex 11, what specific requirements apply to data storage and archiving for computerised systems?

Choices

  1. A. Data may be archived in any format as long as printouts exist
  2. B. Data should be secured by both physical and electronic means against damage, and stored data should be checked for accessibility, readability, and accuracy; access to data should be ensured throughout the retention period
  3. C. Archived data only needs to be readable by the original system that created it
  4. D. Data may be deleted after five years if the product is no longer marketed

Cross-Model Comparison

ModelScoreLatencyTokens InTokens Out
GPT-5.4100.0%2.6s119149
GPT-5.4 mini100.0%1.1s11988
GPT-5.4 nano100.0%1.5s119205
Claude Haiku 4.5100.0%3.7s127301
Claude Sonnet 4.6100.0%9.7s127382
Llama 4 Scout100.0%1.2s124437
Claude Opus 4.6100.0%11.6s127463
Llama 4 Maverick100.0%3.6s125463
Llama 3.3 70B Instruct100.0%6.4s125160
Mistral Small 2603100.0%3.9s132500
Qwen3.5-397B-A17B100.0%11.2s1261,201
DeepSeek-V3.2100.0%56.2s118495
DeepSeek-R1100.0%12.0s124402
DeepSeek-R1-Distill-Qwen-32B100.0%45.8s118485
Mistral Large 3 675B100.0%6.7s120406
Qwen3.5-35B-A3B100.0%7.5s1261,162
Gemini 3.1 Pro100.0%11.7s1141,081
Gemini 3 Flash100.0%3.3s114315
Gemini 3.1 Flash-Lite100.0%2.3s115246

Tags

data_storagearchivingdata_integrityretention