ABSTRACT
Confirming 2003/94/EC and 91/412/EEC, this first principle establishes that computer systems can be used to perform operations covered in the basic legislation compiled in Volume 1 and Volume 5 of the publication “The Rules Governing Medicinal Products in the European Union.”*
This first principle provides as well the definition of “computerized system.” The difference about the subject of the definitions of a computer system between the PI 011-3* and the Annex 11 is curious. Refer to Table 3.1.
