Digital Archiving in the Pharmaceutical Industry While relatively new as a retention method in the drug industry, e-archiving of records is a must-do to best ensure the health of patients and the industry

Offers a checklist to create a digital archives program n the highly regulated world of drug manufacturers, preserving records is a critical requirement for business continuity. So far, paper has been considered the only official documentation format, and microfilm has provided a low-cost – but low-tech – backup solution that is stable over time and essentially technologyindependent. For the past two decades, however, all areas of pharmaceutical development have been generating electronic records. The accumulation of electronic source data and the evolution of electronic documents toward more dynamic forms that can combine written text, bookmarks, hyperlinks, and multimedia features create the need for digital archives and electronic signatures to preserve the integrity of originals. In 1997, the Code of Federal Regulations (CFR), the chief U.S. source for listing regulatory requirements, set the U.S. Food and Drug Administra-tion’s basic rules for the validation of electronic records and electronic signatures (21 CFR part 11). Although archiving electronic records is clearly stipulated in 21 CFR part 11, only lately has the question of the long-term preservation of and access to digital assets arisen among drug makers.