ASTM E1578-13
Standard Guide for Laboratory Informatics

Standard No.

ASTM E1578-13

Release Date

2013

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM E1578-18

Latest

ASTM E1578-18

Scope

4.1 Relevance—This guide is intended to educate those in the intended audience on many aspects of laboratory informatics. Specifically, the guide may:

4.1.1 Help educate new users of laboratory informatics;

4.1.2 Help educate general audiences in laboratories and other organizations that use laboratory informatics;

4.1.3 Help educate instrument manufactures and producers of other commonly interfaced systems;

4.1.4 Provide standard terminology that can be used by laboratory informatics vendors and end users;

4.1.5 Establish a minimum set of requirements for primary laboratory informatics functions;

4.1.6 Provide guidance on the tasks performed and documentation created in the specification, evaluation, cost justification, implementation, project management, training, and documentation of laboratory informatics; and

4.1.7 Provide high-level guidance for the integration of laboratory informatics.

4.2 How Used—This guide is intended to be used by all stakeholders involved in any aspect of laboratory informatics implementation, use or maintenance.

4.2.1 It is intended to be used throughout the laboratory informatics life cycle by individuals or groups responsible for laboratory informatics including specification, build/configuration, validation, use, upgrades, retirement/decommissioning.

4.2.2 It is also intended to provide an example of a laboratory informatics functions checklist.

1.1 This guide helps describe the laboratory informatics landscape and covers issues commonly encountered at all stages in the life cycle of laboratory informatics from inception to retirement. It explains the evolution of laboratory informatics tools used in today’s laboratories such as Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Scientific Data Management Systems (SDMS), and Chromatography Data Systems (CDS). It also covers the relationship (interactions) between these tools and the external systems in a given organization. The guide discusses supporting laboratory informatics tools and a wide variety of the issues commonly encountered at different stages in the life cycle. The sub-sections that follow describe details of scope of this document in specific areas.

1.2 High-Level Purpose—The purpose of this guide includes: (1) helping educate new users of laboratory informatics tools, (2) provide a standard terminology that can be used by different vendors and end users, (3) establish minimum requirements for laboratory informatics, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation of the systems, and (5) provide function checklist examples for laboratory informatics systems that can be adopted within the laboratory and integrated with the existing systems.

ASTM E1578-13 Referenced Document

• ASTM E1340 Standard Guide for Rapid Prototyping of Computerized Systems
• ASTM E2066 
• ISO/IEC 12207 Systems and software engineering - Software life cycle processes

ASTM E1578-13 history

• 2018 ASTM E1578-18 Standard Guide for Laboratory Informatics
• 2013 ASTM E1578-13 Standard Guide for Laboratory Informatics
• 2006 ASTM E1578-06 Standard Guide for Laboratory Information Management Systems (LIMS)
• 1993 ASTM E1578-93(1999) Standard Guide for Laboratory Information Management Systems (LIMS)