The Basis — Scientific Data Management Systems

A scientific data management system combines generic data management capabilities with features required for effective creation, search, and management of scientific information. Although it may include more specialized techniques for performing these tasks, it is principally a management system for electronic records. 

An electronic record represents a record in digital format. Even though the components and requirements of an electronic record are defined by its application, a system for creating and maintaining electronic records has basically the following components  

In addition to these basic components, a scientific data management system usually must address several of the regulatory standards previously described. Some of the required features are as follows  

Authentication is usually performed by entering a unique user identification (ID) and password. If data are transferred automatically from external software, the source system either must provide a similar mechanism to identify a valid user or the external system has to log on to the record manager with a unique identifier. In any case, data that are entering a compliant-ready record manager require this identification. The authentication needs to be logged with a date and time stamp in an audit trail. The same requirement applies to the modification of data that already exist in the record, if the user is not already in an authenticated session. In fully regulated environments, a reason for the modification has to be supplied before changes can be made. 

For operations requiring an electronic signature the following must be included within the functionality of a record manager  

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