Selection of a Scientific Data Management System (SDMS) Based on User Requirements

Abstract

Pharmaceutical research/development and quality control laboratories are faced with prodigious amounts of data from a multitude of heterogeneous data sources in a compliant manner, as mandated by requirements from regulatory agencies like the Food and Drug Administration (FDA). This has forced laboratories to use electronic data/information management systems to capture and maintain this data. Although the use of Laboratory Information Management Systems (LIMS) has gained widespread acceptance, pharmaceutical laboratories still struggle with the idea of system integration and lab automation using electronic laboratory notebooks (ELN) and more specifically scientific data management systems (SDMS), due to a normal resistance to change and a need to protect their existing IT investments. However, a properly assessed and validated SDMS offers the most significant benefits in terms of data quality, compliance, costs, and standardization across laboratories and interface capabilities to collect data from disparate sources and store them in a database for easy retrieval and management. In this research project, a detailed analysis of the functional and non-functional requirements for purchasing a SDMS, in addition to the analysis of the functionality of several of the mostly widely known SDMS is performed to determine which is most suitable for use in the pharmaceutical laboratories surveyed. Finally, validation requirements for a SDMS and more specifically computer system software in general is detailed and explained.