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ASTM E 1578 : 2018

Current

Current

The latest, up-to-date edition.

Standard Guide for Laboratory Informatics

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-08-2018

€94.22
Excluding VAT

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.

Committee
E 13
DocumentType
Guide
Pages
63
ProductNote
THIS STANDARD ALSO REFERS TO ESAR, SEND, CIDX , 21 CFR PART 11, FDA DATA INTEGRITY, HL7, ICH QUALITY GUIDELINE Q9, ISPE GAMP 5, ISPE GAMP GUIDE , MHRA GXP, NCPDP, NIST, 10 CFR APPENDIX B TO PART 50 , 10 CFR APPENDIX E TO PART 50, 10 CFR APPENDIX K TO PART 50, PIC/S, LOINC, SNOMED-CT, WHO
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This 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), laboratory execution systems (LES), laboratory information systems (LIS), 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 subsections that follow describe the scope of this document in specific areas.

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

1.3Laboratory Informatics Definition—Laboratory informatics is the specialized application of information technology aimed at optimizing laboratory operations. It is a collection of informatics tools utilized within laboratory environments to collect, store, process, analyze, report, and archive data and information from the laboratory and its supporting processes. Laboratory informatics includes the effective use of critical data management systems, the electronic delivery of results to customers, and the use and integration of supporting systems (for example, training and policy management). Examples of primary laboratory informatics tools include laboratory information management systems (LIMS), laboratory execution systems (LES), laboratory information systems (LIS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), and chromatography data systems (CDS).

1.4Scope Considerations when Selecting and Implementing Laboratory Informatics Solutions—Many laboratories have determined that they need to deploy multiple laboratory informatics systems to automate their laboratory processes and manage their data. Selection of an informatics solution requires a detailed analysis of the laboratory’s requirements and should not be a simple product category decision. Information technology (IT) representatives and subject matter experts (SMEs) who understand the needs of the laboratory need to be involved in the selection and implementation of a laboratory informatics system to ensure that the needs of the laboratory are met and IT can support it. Customers (internal and external) of laboratory information should also be included in the laboratory informatics solution design to ensure full electronic integration between systems.

1.5The scope of this guide covers a wide range of laboratory types, industries, and sizes. Examples of laboratory types and industries include:

1.5.1General Laboratories:

1.5.1.1Standards (ASTM, IEEE, ISO) and

1.5.1.2Government (EPA, FDA, JPL, NASA, NRC, USDA, USGS, FERC).

1.5.2Environmental:

1.5.2.1Environmental monitoring.

1.5.3Life Science Laboratories:

1.5.3.1Biotechnology and

1.5.3.2Diagnostic.

1.5.4Healthcare and Medical:

1.5.4.1Bionomics/genomics,

1.5.4.2Medical devices,

1.5.4.3Pharmaceutical,

1.5.4.4Veterinary,

1.5.4.5Public health, and

1.5.4.6Hospital.

1.5.5Heavy Industry Laboratories:

1.5.5.1Energy and resources,

1.5.5.2Manufacturing and construction,

1.5.5.3Materials and chemicals, and

1.5.5.4Transportation and shipping.

1.5.6Food and Beverage Laboratories:

1.5.6.1Agriculture,

1.5.6.2Beverages,

1.5.6.3Food, and

1.5.6.4Food service and hospitality.

1.5.7Public Sector Laboratories:

1.5.7.1Law enforcement/forensic,

1.5.7.2State and local government,

1.5.7.3Education and nonprofits, and

1.5.7.4Public utilities (water, electric, waste treatment).

1.6Integration—The scope of integration covered in this guide includes communication and meaningful data exchange between different laboratory informatics tools and other external systems (document management, chromatography data systems, laboratory instruments, spectroscopy data systems, enterprise resource planning (ERP), manufacturing execution systems (MES), investigations/deviations and CAPA management systems), and other integrated business systems (for example, clinical or hospital environments) provide significant business benefits to any laboratory and is discussed at a high level in this guide.

1.7Life-Cycle Phases—The scope of this guide is intended to provide an understanding of laboratory informatics tools’ life cycle from project initiation point to retirement and decommissioning. This guide was designed to help newer audiences in understanding the complexity in the relationships between different laboratory informatics tools and how to plan and manage the implementation project, while seasoned users may use the different life cycles to maintain existing laboratory informatics tools. Integrating additional informatics tools to existing ones in today’s evolving laboratory environment adds constraints that need to be considered. The life-cycle discussion includes both the laboratory informatics solution life cycle as well as the project life cycle.

1.7.1The product life cycle encompasses a specific laboratory informatics system and the expected useful life of that system before it needs to be replaced or upgraded.

1.7.2The project life cycle encompasses the activities to acquire, implement, operate, and eventually retire a specific laboratory informatics system.

1.8Audience—This guide has been created with the needs of the following stakeholders in mind: (1) end users of laboratory informatics tools, (2) implementers of laboratory informatics tools, (3) quality personnel, (4) information technology personnel, (5) laboratory informatics tools vendors, (6) instrument vendors, (7) individuals who approve laboratory informatics tools funding, (8) laboratory informatics applications support specialists, and (9) software test/validation specialists. Information contained in this guide will benefit a broad audience of people who work in or interact with a laboratory. New users can use this guide to understand the purpose and functions of the wide variety of laboratory informatics tools as well as the interactions between these tools with external systems. The guide can also help prospective users in understanding terminology, configurations, features, design, benefits, and costs of these different laboratory informatics tools. Individuals who are purchasing specific tools may also use this guide to identify functions that are recommended for specific laboratory environments. Research and development staff of different commercial laboratory informatics systems vendors may use the guide as a tool to evaluate, identify, and potentially improve the capabilities of their products. The vendors’ sales staff may use the guide to represent functions of their laboratory informatics products to prospective customers in more generic and product-neutral terms.

1.9Out of Scope—This guide does not attempt to define the boundaries of laboratory informatics, as they continue to evolve and blur between the different types of tools; rather, it focuses on the functionality that is provided by laboratory informatics as a whole.

1.10This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM E 2538 : 2006 : R2011 Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020)
ASTM E 2473 : 2005 : R2011 Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record (Withdrawn 2020)
ASTM C 1009 : 2013 : REV A Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry

ASTM E 2077 : 2000 : R2016 Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 1948 : 1998 Standard Guide for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 1947 : 1998 Standard Specification for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 2369 : 2005 : EDT 2 Standard Specification for Continuity of Care Record (CCR)
ASTM E 2077 : 2000 : R2024 Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 1948 : 1998 : R2004 Standard Guide for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 1947 : 1998 : R2009 Standard Specification for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 2077 : 2000 Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 1947 : 1998 : R2014 Standard Specification for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 2078 : 2000 : R2024 Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2077 : 2000 : R2010 Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2078 : 2000 Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 1948 : 1998 : R2014 Standard Guide for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 1947 : 1998 : R2004 Standard Specification for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 1947 : 1998 : R2022 Standard Specification for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 1948 : 1998 : R2022 Standard Guide for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 2078 : 2000 : R2010 Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2369 : 2012 Standard Specification for Continuity of Care Record (CCR) (Withdrawn 2021)
ASTM E 2078 : 2000 : R2005 Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2078 : 2000 : R2016 Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2369 : 2005 : EDT 1 Standard Specification for Continuity of Care Record (CCR)
ASTM E 1948 : 1998 : R2009 Standard Guide for Analytical Data Interchange Protocol for Chromatographic Data
ASTM E 2077 : 2000 : R2005 Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
ASTM E 2369 : 2005 Standard Specification for Continuity of Care Record (CCR)

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