Backup tapes are not electronic archives. …System backups are designed to serve the immediate needs of the IT department for restoring interrupted services and disaster recovery. …Long term in the IT world is six months, not six years, or more than 20 years as in regulatory terms. (297-298)

 

The unacknowledged “elephant” in the room of many pharmaceutical companies is the conversion that has taken place of their huge and ever increasing collection of regulated data and documents from paper form to electronic form. Familiar with organizing themselves to fill and manage access/retrieval to mountainsides of paper and microfilm documentation, the move to a comparable, scalable capability for managing access/retrieval of electronic records over required retention years has been daunting to the point of paralysis. “We have our backup tapes” has become their futile mantra.

While electronic archives may contain some “backup” tapes, CDs or DVDs, they are not the regular IT backup tapes performed on a daily basis for Data Center purposes. Daily and monthly backups are designed to bring back server environments and whole databases in case of power outage or other system disaster. They are not organized for convenient search and retrieval of specific data content over long regulatory retention times and the IT staff does not have “digital librarian” knowledge of the content within the many applications and databases they support.

For decades, regulated companies have kept huge paper archives of all their laboratory notebooks, clinical studies, regulatory submissions, and manufacturing records. Now that most of this material has become computer based, attention must be given to establishing electronic digital archives that are organized for search and retrieval over many years. The requirements for maintaining readable electronic media must be defined, met and actively managed for such repositories and strict security measures for read only controlled access installed. In addition an indexed catalog process is required to provide a navigable window into the content of the archived records. All of these tasks are in the role of the Digital Archivist and the company’s archival department.

Establishing a Corporate Digital Archive gives the organization a unique opportunity to consolidate its digital assets in one organized and protected electronic archive that is searchable from a content basis. Various country level projects over the last decade have produced new tools to make this possible and there is now an ISO standard to provide further OAIS guidance (ISO 14721:2003). The following link (http://public.ccsds.org/publications/archive/650x0b1.PDF ) will connect the reader to a document that provides an in-depth discussion of a “Model for an Open Archival Information System (OAIS).” This document was recommended as a space data systems standard in 2002 and adopted as an ISO standard in 2003.

 

Next Month: Provenance and Original Order

In accepting records for an archive the archivist’s first priority is to identify the person or organization that produced the records and determined their content…the principle of “Provenance.” The second principle of the archivist is that of “Original Order.” (301)