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Under 21 CFR Part 11 Section 11.10, which of the following is required for systems that maintain closed electronic records?

Knowledge QA21cfr11hard

Question

Under 21 CFR Part 11 Section 11.10, which of the following is required for systems that maintain closed electronic records?

Choices

A. Biometric identification for all users
B. Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records
C. Paper backup copies of all electronic records
D. Annual recertification of all electronic signatures

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GPT-5.4	100.0%	3.2s	88	162
GPT-5.4 mini	100.0%	901ms	88	62
GPT-5.4 nano	100.0%	764ms	88	59
Claude Haiku 4.5	100.0%	2.9s	96	302
Claude Sonnet 4.6	100.0%	8.5s	96	330
Claude Opus 4.6	100.0%	8.2s	96	328
Llama 4 Scout	100.0%	5.9s	92	421
Llama 4 Maverick	100.0%	18.1s	92	456
Llama 3.3 70B Instruct	100.0%	8.9s	93	249
Mistral Small 2603	100.0%	2.2s	102	346
Qwen3.5-397B-A17B	100.0%	34.2s	97	1,252
DeepSeek-V3.2	100.0%	4.0s	86	168
DeepSeek-R1	100.0%	11.4s	92	381
DeepSeek-R1-Distill-Qwen-32B	100.0%	25.4s	89	657
Mistral Large 3 675B	100.0%	6.9s	90	433
Qwen3.5-35B-A3B	100.0%	603.7s	97	85,965
Gemini 3.1 Pro	100.0%	9.3s	87	921
Gemini 3 Flash	100.0%	2.6s	87	254
Gemini 3.1 Flash-Lite	100.0%	1.9s	88	242

Tags

closed_systemsvalidationcompliance