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ASTM E1578-18

(Guide)

Standard Guide for Laboratory Informatics

Standard Guide for Laboratory Informatics

SIGNIFICANCE AND USE
4.1 Relevance—This guide is intended to educate 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 and other software tools.  
4.2 How to be 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 implementation and use, including specification, build/configuration, validation, use, upgrades, and retirement/decommissioning.  
4.2.2 This guide also provides an example of a laboratory informatics functional requirements checklist that can be used to guide the purchase, upgrade, or development of a laboratory informatics system.
SCOPE
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), 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.  
1.2 High-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.  
1.3 Laboratory 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 chromat...

General Information

Status
Published
Publication Date
31-Jul-2018
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E13 - Molecular Spectroscopy and Separation Science
Drafting Committee
E13.15 - Analytical Data
Current Stage
Ref Project

Relations

Refers
ASTM E2077-00(2016) - Standard Specification for Analytical Data Interchange Protocol for Mass Spectrometric Data
Effective Date
01-Apr-2016
Refers
ASTM E2078-00(2016) - Standard Guide for Analytical Data Interchange Protocol for Mass Spectrometric Data
Effective Date
01-Apr-2016
Referred By
ASTM C1009-21 - Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Effective Date
01-Aug-2018

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Standards Content (Sample)

This 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.
Designation: E1578 − 18
Standard Guide for
1
Laboratory Informatics
This standard is issued under the fixed designation E1578; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope primary laboratory informatics tools include laboratory infor-
mation management systems (LIMS), laboratory execution
1.1 This guide helps describe the laboratory informatics
systems (LES), laboratory information systems (LIS), elec-
landscape and covers issues commonly encountered at all
troniclaboratorynotebooks(ELN),scientificdatamanagement
stagesinthelifecycleoflaboratoryinformaticsfrominception
systems (SDMS), and chromatography data systems (CDS).
to retirement. It explains the evolution of laboratory informat-
ics tools used in today’s laboratories such as laboratory
1.4 Scope Considerations when Selecting and Implementing
information management systems (LIMS), laboratory execu- Laboratory Informatics Solutions—Many laboratories have
tion systems (LES), laboratory information systems (LIS),
determined that they need to deploy multiple laboratory
electronic laboratory notebooks (ELN), scientific data manage- informatics systems to automate their laboratory processes and
ment systems (SDMS), and chromatography data systems
managetheirdata.Selectionofaninformaticssolutionrequires
(CDS). It also covers the relationship (interactions) between a detailed analysis of the laboratory’s requirements and should
these tools and the external systems in a given organization.
not be a simple product category decision. Information tech-
The guide discusses supporting laboratory informatics tools nology (IT) representatives and subject matter experts (SMEs)
and a wide variety of the issues commonly encountered at
whounderstandtheneedsofthelaboratoryneedtobeinvolved
different stages in the life cycle. The subsections that follow in the selection and implementation of a laboratory informatics
describe the scope of this document in specific areas. systemtoensurethattheneedsofthelaboratoryaremetandIT
can support it. Customers (internal and external) of laboratory
1.2 High-Level Purpose—The purpose of this guide in-
information should also be included in the laboratory informat-
cludes: (1) educating new users on laboratory informatics
icssolutiondesigntoensurefullelectronicintegrationbetween
tools; (2) providing a standard terminology that can be used by
systems.
different vendors and end users; (3) establishing minimum
requirements for laboratory informatics; (4) providing guid- 1.5 The scope of this guide covers a wide range of labora-
ance for the specification, evaluation, cost justification,
tory types, industries, and sizes. Examples of laboratory types
implementation, project management, training, and documen-
and industries include:
tation of the systems; and (5) providing a functional require-
1.5.1 General Laboratories:
ments checklist for laboratory informatics systems that can be
1.5.1.1 Standards (ASTM, IEEE, ISO) and
adopted within the laboratory and integrated with existing
1.5.1.2 Government(EPA,FDA,JPL,NASA,NRC,USDA,
systems.
USGS, FERC).
1.5.2 Environmental:
1.3 Laboratory Informatics Definition—Laboratory infor-
1.5.2.1 Environmental monitoring.
matics is the specialized application of information technology
1.5.3 Life Science Laboratories:
aimed at optimizing laboratory operations. It is a collection of
1.5.3.1 Biotechnology and
informatics tools utilized within laboratory environments to
1.5.3.2 Diagnostic.
collect, store, process, analyze, report, and archive data and
1.5.4 Healthcare and Medical:
information from the laboratory and its supporting processes.
1.5.4.1 Bionomics/genomics,
Laboratory informatics includes the effective use of critical
data management systems, the electronic delivery of results to 1.5.4.2 Medical devices,
customers, and the use and integration of supporting systems 1.5.4.3 Pharmaceutical,
(for example, training and policy management). Examples of
1.5.4.4 Veterinary,
1.5.4.5 Public health, and
1 1.5.4.6 Hospital.
This guide is under the jurisdiction of ASTM Committee E13 on Molecular
Spectroscopy and Separation Science and is the direct responsibility of Subcom- 1.5.5 Heavy Industry Laboratories:
mittee E13.15 on Analytical Data.
1.5.5.1 Energy and resources,
Current edition approved Aug. 1, 2018. Published September 2018. Originally
1.5.5.2 Manufacturing and construction,
approved in 1993. Last previous edition approved in 2013 as E15
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1578 − 13 E1578 − 18
Standard Guide for
1
Laboratory Informatics
This standard is issued under the fixed designation E1578; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
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 Systemslaboratory 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
sub-sectionssubsections that follow describe details of the scope of this document in specific areas.
1.2 High-Level Purpose—The purpose of this guide includes: (1) helping educate educating new users ofon laboratory
informatics tools,tools; (2) provideproviding a standard terminology that can be used by different vendors and end users,users; (3)
establishestablishing minimum requirements for laboratory informatics,informatics; (4) provideproviding guidance for the
specification, evaluation, cost justification, implementation, project management, training, and documentation of the systems,
systems; and (5) provide function checklist examples providing a functional requirements checklist for laboratory informatics
systems that can be adopted within the laboratory and integrated with the existing systems.
1.3 Laboratory 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 integration of effective use of critical data management systems, the electronic delivery of results to customers, and
the use and integration of supporting systems including (for example, training and policies. policy management). Examples of
primary laboratory informatics include: Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks
(ELNs), Chromatography Data Systems (CDS), and Scientific Data Management Systems (SDMS).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).
NOTE 1—Laboratory informatics scope encompasses multiple technical solutions or systems. The division between these system categories continues
to soften as functionality continues to be added to each of them. LIMS were originally created to address the laboratories’ need to manage laboratory
operations and data, provide traceability for all laboratory samples and equipment, and ensure that laboratory procedures are followed. ELNs, on the other
hand, were originally created to meet the scientists’ need to document their experimental design, execution, and conclusions in an electronic format instead
of in a paper notebook. SDMS was created to provide a repository of all scientific data files and results regardless of instrument type. The current
definitions of each of these system categories are far more encompassing.
1.4 Scope Considerations Whenwhen Selecting and Implementing Laboratory Informatics Solutions—Many laboratories have
determined that they need to deploy multiple laboratory informatics systems to automate their laboratory processprocesses and
manage their data. Selection of an informatics solution requires a detailed analysis of the laboratory’s requirements rather than by
choosing a
...

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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This 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.

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ASTM
ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This 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.

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ASTM
ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.  
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom  
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.  
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.  
1.3 All values are stated in SI units.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This 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.

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ASTM E2920-19(Guide)
Standard Guide for Recording Occupational Injuries and Illnesses

SIGNIFICANCE AND USE
4.1 This guide is intended to define work-related injuries and illnesses in a way that can be easily understood and measured across countries. These injuries and illnesses can be used to evaluate, compare, and continually improve management systems and programs related to worker safety and health. Although several levels of severity may be defined, the primary objective is to identify cases with meaningful connection to work and cases with such potential consequence that they have value for prevention purposes. The resultant data and incidence rates should improve global benchmarking consistency.  
4.2 This guide defines recording criteria for Level One cases—cases that have a clear connection to the workplace and consequences that are significant for driving injury and illness prevention and efforts.  
4.3 While not mandated by this guide, recording of Level Two cases is encouraged and will still be mandatory in many jurisdictions. Level Two cases are those cases currently required to be reported by countries, states, and other jurisdictions.
SCOPE
1.1 This guide is intended to establish definitions and criteria for recording occupational injuries and illnesses to be used for measuring safety performance, evaluating safety program performance, and improving consistency when comparing international performance. A measurement system is desired that is precise and accurate, difficult to manipulate, significant and meaningful for safety program evaluation, and appropriate for accountability purposes in a global environment.  
1.2 Objectives of the occupational injury and illness measurement guide are as follows:  
1.2.1 Provide a uniform and objective framework for recording work-related injuries and illnesses,  
1.2.2 Facilitate use of injury and illness rates as a means of evaluating programs designed to control such injuries and illnesses, and  
1.2.3 Establish a basis for meaningful comparison of injury and illness rates across industries and countries.  
1.3 In this guide, definitions and procedures necessary to maintain work-related injury and illness records and incidence rates are covered.  
1.4 Key elements of this guide include work relationship, definition of injuries and illnesses, levels of severity of occupational incidents, accountability for contractor relationships, and specifications for injury and illness rate calculations.  
1.5 Units—The values stated in English (or Imperial) units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. This standard is not a substitute for any legally required injury and illness recordkeeping obligations.  
1.7 This 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.

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