In March 1997 the US Food and Drug Administration (FDA) published its final rule about the use of electronic records and electronic signatures in GxP/FDA-regulated industries. This rule, published in Title 21, part 11 of the Code of Federal Regulations (21 CFR part 11) became effective in August 1997.
21 CFR part 11 specifies the technical and organizational controls that must be in place in order to use electronic data and documents in lieu of paper records for the documentation of GxP processes.
Since then, all branches of pharmaceutical-, medical devices- and other FDA-regulated industries, especially those who work under GxP, are obliged to bring their computer systems and computerized equipment which generates such data or documentation, in compliance with 21 CFR part 11. This is also true for non-US companies who export to the USA or supply equipment and services to the US market.
Thus, in a global industry like pharmaceutical or biotech, 21 CFR part 11 has become the virtual standard, to which computerized systems and electronic data management are aligned in most international companies.