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ASTM E1578-06

(Guide)

Standard Guide for Laboratory Information Management Systems (LIMS)

Standard Guide for Laboratory Information Management Systems (LIMS)

SIGNIFICANCE AND USE
Relevance—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 Used—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.
SCOPE
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 this guide are directed at medium and large laboratories.
1.5 IntegrationIntegration between LIMS and other external systems (document management, chromatography data systems, laboratory instruments, spectroscopic data systems, Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Corrective Action and Preventative Action (CAPA), Electronic Laboratory Notebooks (ELNs) and data archive) provides significant business...

General Information

Status
Historical
Publication Date
31-Aug-2006
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

Replaces
ASTM E1578-93(1999) - Standard Guide for Laboratory Information Management Systems (LIMS)
Effective Date
01-Sep-2006
Replaced By
ASTM E1578-13 - Standard Guide for Laboratory Informatics
Effective Date
01-Aug-2013
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-Sep-2006

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ASTM E1578-06 - Standard Guide for Laboratory Information Management Systems (LIMS)ASTM E1578-06 - Standard Guide for Laboratory Information Management Systems (LIMS)
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ASTM E1578-06 - Standard Guide for Laboratory Information Management Systems (LIMS)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1578 − 06
StandardGuide for
1
Laboratory Information Management Systems (LIMS)
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 1.4.4.2 Manufacturing & Construction,
1.4.4.3 Materials & Chemicals, and
1.1 This guide covers issues commonly encountered at all
1.4.4.4 Transportation & Shipping.
stages in the life cycle of Laboratory Information Management
1.4.5 Food & Beverage Laboratories:
Systems from inception to retirement. The sub-sections that
1.4.5.1 Agriculture,
follow describe details of scope of this document in specific
1.4.5.2 Beverages,
areas.
1.4.5.3 Food, and
1.2 High Level Purpose—The purpose of this guide in-
1.4.5.4 Food Service & Hospitality.
cludes: (1) help educate new users of Laboratory Information
1.4.6 Public Sector Laboratories:
Management Systems (LIMS), (2) provide standard terminol-
1.4.6.1 Law Enforcement,
ogy that can be used by LIMS vendors and end users, (3)
1.4.6.2 State & Local Government,
establish minimum requirements for primary LIMS functions,
1.4.6.3 Education, and
(4) provide guidance for the specification, evaluation, cost
1.4.6.4 Public Utilities (Water, Electric, Waste Treatment).
justification, implementation, project management, training,
1.4.7 Laboratory Size:
and documentation, and (5) provide an example of a LIMS
1.4.7.1 This guide covers topics regarding LIMS for a range
function checklist.
of laboratory sizes ranging from small with simple require-
1.3 LIMS Definition—The term Laboratory Information
ments to large multi-site/global laboratories with complex
Management Systems (LIMS) describes the class of computer
requirements. Although the guide addresses complex issues
systems designed to manage laboratory information.
that impact primarily large LIMS implementations, laborato-
1.4 Laboratory Categories—The spectrum of laboratories
ries of all sizes will find this guide useful. The implementation
that employ LIMS is wide spread. The following break down
times and recommendations listed in this guide are directed at
provides an overview of the laboratory categories that use
medium and large laboratories.
LIMS as well as examples of laboratories in each category.
1.5 Integration—IntegrationbetweenLIMSandotherexter-
1.4.1 General Laboratories:
nal systems (document management, chromatography data
1.4.1.1 Standards (ASTM, IEEE, ISO), and
systems, laboratory instruments, spectroscopic data systems,
1.4.1.2 Government(EPA,FDA,JPL,NASA,NRC,USDA,
Enterprise Resource Planning (ERP), Manufacturing Execu-
FERC).
tion Systems (MES), Corrective Action and Preventative Ac-
1.4.2 Environmental:
tion (CAPA), Electronic Laboratory Notebooks (ELNs) and
1.4.2.1 Environmental Monitoring.
data archive) provides significant business benefits to any
1.4.3 Life Science Laboratories:
laboratory. Integration between LIMS and other external sys-
1.4.3.1 Biotechnology,
tems is discussed at a high level in this guide including data
1.4.3.2 Diagnostic,
interchange and XML standards.
1.4.3.3 Healthcare Medical,
1.6 Lifecycle Phases—The LIMS lifecycle described in this
1.4.3.4 Devices, and
guide includes the following phases: (1) project initiation, (2)
1.4.3.5 Pharmaceuticals Vet/Animal.
requirements analysis, (3) design, (4) build/configure, (5) test
1.4.4 Heavy Industry Laboratories:
and commission, (6) operation and maintenance, and (7)
1.4.4.1 Energy & Resources,
retirement. This guide is intended to provide an understanding
of the LIMS system life cycle and good practices for each of
1
the activities. It will help first time LIMS implementers plan
This guide is under the jurisdiction of ASTM Committee E13 on Molecular
Spectroscopy and Separation Science and is the direct responsibility of Subcom-
and manage their LIMS projects while seasoned LIMS users
mittee E13.15 on Analytical Data.
may use the LIMS system life cycle to maintain existing LIMS
Current edition approved Sept. 1, 2006. Published September 2006. Originally
and prepare for the implementation of the next generation
approved in 1993. Last previous edition approved in 1999 as E1578 – 93 (1999).
DOI: 10.1520/E1578-06. LIMS.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1578 − 06
1.7 Audience—This guide has been created with the needs EPA 2185 Good Automated Laboratory Practices Principles
of the following stakeholders in mind: (1) end users of LIMS, and Guidance to Regulations For Ensuring Data Integrity
(2) impleme
...

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4.1 Relevance—This guide is intended to educate the intended audience on many aspects of laboratory informatics. Specifically, the guide may:  
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SIGNIFICANCE AND USE
4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
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1.1 This guide covers the evaluation, qualification, and quantification of digital neutron images. These images can be acquired by many methods, including: neutron sensitive imaging plates (Computed Radiography – CR), Digital Detector Arrays – DDA’s (amorphous silicon, CMOS, CCD, etc.), micro-channel plates, neutron sensitive fluoroscopes, neutron sensitive scintillators coupled to optical cameras, digitized radiographic films, and linear diode arrays.  
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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.  
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1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
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5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
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1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
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5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
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1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
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ASTM
ASTM E2767-21(Practice)
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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