GMP Bench
← Back to Test Cases

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

No models have been evaluated on this test case yet.

Tags

data_storagearchivingdata_integrityretention