In 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 technology-independent. 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.
Data and Documents
In addition to the traditional administrative information on employees, payroll information, network access, and e-mail, pharmaceutical companies retain a large number of records pertaining to their research and development activities: laboratory notebook data from pre-clinical research, case report forms and trial master files from clinical research activities--as well as large databases of raw and surrogate clinical data. To these, one has to add a variety of other data sets on standard operating procedures, training, systems validation, systems access records, and more. All this information is crucial to business either from a knowledge management or a regulatory-compliance point of view.
The duration of retention for pharmaceutical records has been the object of great debate among specialists from different areas. To various parties, the picture looks different. Regulatory requirements in the United States define a two-year post-approval retention period for all the documentation supporting the filing for a new drug approval (NDA). New submissions, of course, re-set the clock. In the European Union, the retention period is 15 years from generation of a record. But regulatory requirements are not the only reason for records retention. Patent disputes, legal actions from patients and, of course, knowledge management can dictate a whole new set of rules for documents and data retention. So far, the simplest way many pharmaceutical companies have found for dealing with the complexity of the situation has been to retain paper copies of everything indefinitely.
In most cases, e-documents were viewed as interim manifestations of a final hard copy or, at best, as backups for those hard copies. Storage and preservation of e-records has remained off the radar screen of most pharmaceutical organizations.
Databases have been around much longer than e-documents, but this only seems to translate to a longer and more painful history of records lost, IT incompatibilities, and other unpleasant surprises. There are countless examples of databases lost only months after they were created.
The (e) Document Management Landscape
The pharmaceutical industry has been generating official electronic documents for more than a decade--the most prominent being e-NDAs. Laboratory instruments, diagnostic devices, electronic data capture tools, electronic patient diaries, and electronic data transfers from external partners are all generating source data that need to be archived. Many companies, including those in the...