Long-term retention of authentic electronic records is of significant importance to the pharmaceutical industry, from many standpoints including legal, regulatory and intellectual property protection. The risk of losing access to critical business information in the future could potentially be detrimental to a pharmaceutical business. The industry in the main has relied on a variety of archival approaches, such as using file systems and content management systems and keeping operational systems alive beyond their intended lifetime; unfortunately, none of these approaches are sustainable in the long-term and do not address the serious issue of loss of access through technology obsolescence.The eArchive service has been developed by AstraZeneca to manage the long-term preservation of electronic records, and to begin to address the issue of technology obsolescence. The system is intended to ingest and reliably maintain electronic records from all areas of the global business with retention periods ranging from seven years to many decades. A wide variety of both proprietary and non-proprietary formats are used for the creation of AstraZeneca records; to date, there has been little focus on generating records in formats suitable for long-term preservation. As a result, many records requiring long-term retention may become at risk of format obsolescence unless action is taken. The eArchive service contains mechanisms to mitigate against such risks and facilitate continued access to authentic content throughout a records retention period. In addition to ensuring continued access, strict records management policies must also be enforced. Material must be disposed of once its retention period has been reached, as long as it is not required for ongoing litigation (on legal hold).This paper describes a practical and extensible approach employed by the eArchive service for providing cost-effective and sustainable access to electronic records over time. The solution has been developed in accordance with the Open Archival Information System (OAIS) reference model and AstraZeneca's own enterprise architecture. Consideration has also been given to records management activities, such as appraisal and disposition that are not described within the OAIS reference model.The primary approach has been to maximize the use of robust COTS (Commercial off the Shelf) products to form the core of the solution. Customizations are applied where appropriate. Concepts and tools developed by the EU Planets program have also been incorporated into the design, as well as aspects of metadata standards such as PREMIS and Dublin Core.Format migration has been adopted as the long-term preservation mechanism, in addition to a policy of accepting only a limited number of “Preservation Ready” formats. As a result, many of the format migrations will take place prior to ingest into the eArchive system. This paper will describe in detail the approach to preservation policy, identification and selection of preservation pathways and methods of validating the authenticity for long-term preservation of digital images. The tiered fidelity model, based on business requirements, will also be introduced and described in detail.
Mark Pickering, Mark Evans, "The eArchive Service: A practical, cost-effective and sustainable approach for preserving authentic electronic records at AstraZeneca" in Proc. IS&T Archiving 2010, 2010, pp 42 - 47, https://doi.org/10.2352/issn.2168-3204.2010.7.1.art00009