The pharmaceutical industry is regulated heavily globally and is constantly challenged by ever-evolving stringent regulations, and the need to ensure compliance. In 1997, the United States Food and Drug Administration (US FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures (Part 11, Electronic Records; Electronic Signatures). EU Annex 11 details the European Medicines Agency (EMA) Good Manufacturing Practices (GMP) requirements for computer systems.
In January 2002, the FDA issued the General Principles of Software Validation; Final Guidance for Industry and FDA Staff. This guidance applies to any computerised system and software in the life sciences industry that is used to automate device design, testing, component acceptance, manufacturing, labelling, packaging, distribution, or complaint handling, or to automate any other aspect of the quality system in USA. In addition, computer systems that are used to create, modify, and maintain electronic records, and to manage electronic signatures, are also subject to validation requirements. A critical component of the validation effort is to provide a high degree of assurance such that the product/process meets its pre-determined specifications and quality attributes.