1. Scope

1.1 This guide describes computer systems used to manage laboratory information. The term Laboratory Information Management Systems (LIMS) describes this class of computer systems.

1.2 This guide covers LIMS ranging from small laboratories with simple requirements to large multi-site laboratories with complex requirements. The elements of the LIMS guide may be selected based on specific laboratory requirements.

1.3 The audience of this document includes: (1) end users of LIMS, (2) implementers of LIMS, (3) LIMS vendors, (4) instrument vendors, and (5) individuals who must approve LIMS funding.

1.4 The purpose of this guide includes: (1) help educate new users of Laboratory Information Management Systems (LIMS), (2) provide standard terminology that can be used by LIMS vendors and end users, (3) establish minimum requirements for primary LIMS functions, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation, and (5) provide an example of a LIMS function checklist.

1.5 Information contained in this guide will benefit a broad audience of people who work or interact with a laboratory. New LIMS users can use this guide to understand the purpose and functions of LIMS. The guide can help prospective LIMS users in understanding terminology, configurations, features, design, and costs. Individuals who are purchasing a LIMS can use this guide to identify functions that are recommended for specific laboratory environments. LIMS vendor Research and Development staffs can use the guide as a tool to evaluate, identify, and correct areas that need improvement. LIMS vendor sales staffs can use the guide to accurately represent functions of their LIMS product to prospective customers. This guide does not define laboratory instrument interfaces.

1.6 This guide can be used by laboratories of all sizes. The guide addresses complex issues that impact primarily large LIMS implementations. Small laboratories should review issues that may impact their environments. The implementation times and recommendations listed in this guide are directed at medium and large laboratories.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E1340 Guide for Rapid Prototyping of Information Systems

E1947 Specification for Analytical Data Interchange Protocol for Chromatographic Data

E1948 Guide for Analytical Data Interchange Protocol for Chromatographic Data

E2066 Guide for Validation of Laboratory Information Management Systems

E2077 Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data

E2078 Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data

ANSI Standards

EPA Data Standards

FDA Regulations

Keywords

Information systems; Laboratory; LIMS (laboratory information management systems); LIMS (laboratory information management systems), guide;

ICS Code

ICS Number Code 35.240.80 (IT applications in health care technology)

DOI: 10.1520/E1578-93R99

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