According to EU GMP Annex 11, what is the fundamental requirement for computerised systems used in GMP-regulated activities?

Choices

1. A. They must use a specific approved operating system
2. B. They should be validated, and the extent of validation should be based on a documented risk assessment
3. C. They only need to be validated if they generate electronic signatures
4. D. Validation is only required for systems purchased after 2011