ABSTRACT
The introduction of regulatory requirements to computer systems by the US Food and Drug Administration (US FDA) can be traced back to the first publication of the Good Manufacturing Process (GMP) regulations. These requirements are applicable to computer systems that have an effect on product quality, and to records known to be required by existing regulation. In 1963, the Code of Federal Regulations (CFR) Part 211.2(b) was incorporated as part of the first publication of the Current Good Manufacturing Practices (cGMP) regulations. It stressed the importance of backups and documentation, including the importance of keeping the hardcopy of master formulas, specifications, test records, master production and control records, and batch production records (i.e., batch production and control records) or calculations.
