Annex 11 of EU GMP guideline. It describes requirements for all kinds of computerized systems used as part of GMP-regulated activities.
A computer-based system is a combination of software and hardware components which together fulfill certain functions. The application should be validated, the IT infrastructure should be qualified.
WHO guidance on good data and record management practices
Another guideline with reference to implementing the legal requirements is the WHO Guideline on Good Practice for Data and Records Management by the World Health