Pfizer Central Research, Sandwich, England has developed an Electronic Archive to support the maintenance and preservation of electronic records used in the discovery and development of new medicines. The Archive has been developed to meet regulatory, scientific and business requirements. The long-term preservation of electronic records requires that migration strategies be developed both for the Archive and the records held within the Archive. The modular design of the Archive will facilitate the migration of hardware components. Selecting an appropriate migration strategy for electronic records requires careful project management skills allied to appraisal and retention management. Having identified when the migration of records is necessary, it is crucial that alternative technical solutions remain open.
DOI
10.1023/A:1009093604632
Critical Arguements
CA Describes a system of archiving and migration of electronic records (Electronic Archive) at Pfizer Central Research. "Our objective is to provide long-term, safe and secure storage for electronic records. The archive acts as an electronic record center and borrows much from traditional archive theory." (p. 301)
Phrases
<P1> Migration, an essential part of the life-cycle of electronic records, is not an activity that occurs in isolation. It is deeply related to the "Warrant" which justifies our record-keeping systems, and to the metadata which describe the data on our systems. (p. 301-302) <warrant> <P2> Our approach to electronic archiving, and consequently our migration strategy, has been shaped by the business requirements of the Pharmaceutical industry, the technical infrastructure in which we work, the nature of scientific research and development, and by new applications for traditional archival skills. <warrant> (p. 302) <P3> The Pharmaceutical industry is regulated by industry Good Practice Guidelines such as Good Laboratory Practice, Good Clinical Practice and GoodManufacturing Practice. Adherence to these standards is monitored by Government agencies such as the U.S. Food and Drug Administration (FDA) and in Britain the Department of Health (DoH). The guidelines require that data relating to any compound used in man be kept for the lifetime of that compound during its use in man. This we may take to be 40 years or more, during which time the data must remain identifiable and reproducible in case of regulatory inspection. <warrant> (p. 302) <P4> The record-keeping requirements of the scientific research and development process also shape migration strategies. ... Data must be able to be manipulated as well as being identifiable and legible. <warrant> (p. 303) <P5> [W]e have adapted traditional archival theory to our working environment and the new imperatives of electronic archiving. We have utilised retention scheduling to provide a vehicle for metadata file description alongside retention requirements. We have also placed great importance on appraisal as a tool to evaluate records which require to be migrated. (p. 303) <P6> Software application information is therefore collected as part of the metadata description for each file. (p. 303) <P7> The migration of the database fromone version to another or to a new schema represents a significant migration challenge in terms of the project management and validation necessary to demonstrate that a new database accurately represents our original data set. (p. 303-304) <P8> Assessing the risk of migration exercises is only one of several issues we have identified which need to be addressed before any migration of the archive or its components takes place. (p. 304) <P9> [F]ew organisations can cut themselves off totally from their existing record-keeping systems, whether they be paper or electronic. (p. 304) <P10> Critical to this model is identifying the data which are worthy of long-term preservation and transfer to the Archive. This introduces new applications for the retention and appraisal of electronic records. Traditional archival skills can be utilised in deciding which records are worthy of retention. Once they are in the Archive it will become critical to return time and again to those records in a process of "constant review" to ensure that records remain, identifiable, legible and manipulatable. (p. 305) <P11> Having decided when to migrate electronic records, it is important to decide if it is worth it. Our role in Records Management is to inform the business leaders and budget holders when a migration of electronic records will be necessary. It is also our role to provide the business with an informed decision. A key vehicle in this process will be the retention schedule, which is not simply a tool to schedule the destruction of records. It could also be used to schedule software versions. More importantly, with event driven requirements it is a vehicle for constant review and appraisal of record holdings. The Schedule also defines important parts of the metadata description for each file in the Archive. The role of appraisal is critical in evaluating record holdings from a migration point of view and will demand greater time and resources from archivists and records managers. (p. 305)
Conclusions
RQ "Any migration of electronic records must be supported by full project management. Migration of electronic records is an increasingly complex area, with the advent of relational databases, multi-dimensional records and the World Wide Web. New solutions must be found, and new research undertaken. ... To develop a methodology for the migration of electronic records demands further exploration of the role of the "warrant" both external and internal to any organisation, which underpins electronic record-keeping practices. It will become critical to find new and practical ways to identify source software applications. ... The role of archival theory, especially appraisal and retention scheduling, in migration strategies demands greater consideration. ... The issues raised by complex documents are perhaps the area which demands the greatest research for the future. In this respect however, the agenda is being set by vendors promoting new technologies with short-term business goals. It may appear that electronic records do not lend themselves to long-term preservation. ... The development, management and operation of an Electronic Archive and migration strategy demands a multitude of skills that can only be achieved by a multi-disciplinary team of user, records management, IT, and computing expertise. Reassuringly, the key factor in migrating electronic archives will remain people." (p. 306)
