Compliance

Regulations and Good Practices are applied in validation, such as

EU GMP, annex 11 (Computerised Systems)
EU GMP, annex 15 (Qualification and Validation)
FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
FDA 21 CFR part 820 (Medical Devices – Quality System Regulation)
ISPE GAMP5 (A Risk-Based Approach to Compliant GxP Computerized Systems)
PIC/S (Good practices for computerised systems in regulated "GxP" environments)

Appliance

Requirements depend on object to be validated and authorities to be complied. Pharmaceutical societies have written different Good Practices for application of regulations.

Application of regulations in practice needs special knowledge which is my strength.