Relevance8212;This guide is intended to educate those in the intended audience on many aspects of LIMS. Specifically, the guide may:
4.1.1 Help educate new users of LIMS;
4.1.2 Help educate general audiences in laboratories and other organizations that use LIMS;
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 LIMS vendors and end users;
4.1.5 Establish a minimum set of requirements for primary LIMS 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 LIMS; and
4.1.7 Provide high-level guidance for the integration of LIMS with the most commonly integrated systems such as laboratory instruments, CDS, ERP, ELN, SDMS and so forth.
How Used8212;This guide is intended to be used by all stakeholders involved in any aspect of LIMS implementation or maintenance.
4.2.1 It is intended to be used throughout the LIMS life cycle by individuals or groups responsible for LIMS including specification, build/configuration, validation, use, upgrades, retirement/decommissioning.
4.2.2 It is also intended to provide an example of a LIMS function checklist.
1.1 This guide covers issues commonly encountered at all stages in the life cycle of Laboratory Information Management Systems from inception to retirement. The sub-sections that follow describe details of scope of this document in specific areas.
1.2 High Level PurposeThe 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.
1.3 LIMS DefinitionThe term Laboratory Information Management Systems (LIMS) describes the class of computer systems designed to manage laboratory information.
1.4 Laboratory CategoriesThe spectrum of laboratories that employ LIMS is wide spread. The following break down provides an overview of the laboratory categories that use LIMS as well as examples of laboratories in each category.
1.4.1 General Laboratories
Standards (ASTM, IEEE, ISO), and
Government (EPA, FDA, JPL, NASA, NRC, USDA, FERC).
1.4.2 Environmental
Environmental Monitoring.
1.4.3 Life Science Laboratories
Biotechnology,
Diagnostic,
Healthcare Medical,
Devices, and
Pharmaceuticals Vet/Animal.
1.4.4 Heavy Industry Laboratories
Energy Resources,
Manufacturing Construction,
Materials Chemicals, and
Transportation Shipping.
1.4.5 Food Beverage Laboratories
Agriculture,
Beverages,
Food, and
Food Service Hospitality.
1.4.6 Public Sector Laboratories
Law Enforcement,
State Local Government,
Education, and
Public Utilities (Water, Electric, Waste Treatment).
1.4.7 Laboratory Size
This guide covers topics regarding LIMS for a range of laboratory sizes ranging from small with simple requirements to large multi-site/global laboratories with complex requirements. Although the guide addresses complex issues that impact primarily large LIMS implementations, laboratories of all sizes will find this guide useful. The implementation times and recommendations listed in......
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