Under EU GMP Annex 11, what are the requirements for audit trails in computerised systems?

Knowledge QAEu Annex11medium

Question

Choices

A. Audit trails are optional for non-critical systems
B. Consideration should be given to building into the system the creation of a record of all GMP-relevant changes and deletions (a system-generated audit trail), and audit trail data should be available, convertible to a generally intelligible form, and regularly reviewed
C. Audit trails are only required for systems handling electronic batch records
D. Audit trails must only capture who made a change, not what was changed

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GPT-5.4	100.0%	2.8s	120	174
GPT-5.4 mini	100.0%	1.1s	120	85
GPT-5.4 nano	100.0%	868ms	120	69
Claude Haiku 4.5	100.0%	3.1s	132	305
Claude Sonnet 4.6	100.0%	8.4s	132	369
Llama 4 Scout	100.0%	6.0s	125	527
Claude Opus 4.6	100.0%	11.1s	132	477
Llama 4 Maverick	100.0%	3.4s	194	415
Llama 3.3 70B Instruct	100.0%	5.4s	128	168
Mistral Small 2603	100.0%	1.9s	134	328
Qwen3.5-397B-A17B	100.0%	21.6s	129	1,377
DeepSeek-V3.2	100.0%	52.3s	119	422
DeepSeek-R1	100.0%	23.9s	125	901
DeepSeek-R1-Distill-Qwen-32B	100.0%	47.4s	121	795
Mistral Large 3 675B	100.0%	5.6s	122	373
Qwen3.5-35B-A3B	100.0%	6.4s	129	1,146
Gemini 3.1 Pro	100.0%	18.2s	116	816
Gemini 3 Flash	100.0%	3.0s	115	297
Gemini 3.1 Flash-Lite	100.0%	2.3s	115	249