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

Choices

1. A. Audit trails are optional for non-critical systems
2. 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
3. C. Audit trails are only required for systems handling electronic batch records
4. D. Audit trails must only capture who made a change, not what was changed