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  • ASTM E 2066 : 2000 : R2007

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Standard Guide for Validation of Laboratory Information Management Systems (Withdrawn 2015)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  09-10-2015

    Language(s):  English

    Published date:  01-03-2007

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 03.06, 2015 Define an approach to the validation process for a Laboratory Information Management System (LIMS).

    Scope - (Show below) - (Hide below)

    1.1 This guide describes an approach to the validation process for a Laboratory Information Management System (LIMS).

    1.2 This guide is for validation of a commercial LIMS purchased from a vendor. The procedures may apply to other types of systems, but this guide makes no claim to address all issues for other types of systems. Further, in-house developed LIMS, that is, those developed by internal or external programmers specifically for an organization, can utilize this guide. It should be noted that there are a number of related software development issues that this guide does not address. Users who embark on developing a LIMS either internally or with external programmers also should consult the appropriate ASTM, ISO, and IEEE software development standards.

    1.3 This guide is intended to educate individuals on LIMS validation, to provide standard terminology useful in discussions with independent validation consultants, and to provide guidance for development of validation plans, test plans, required standard operating procedures, and the final validation report.

    General Product Information - (Show below) - (Hide below)

    Committee E 13
    Document Type Guide
    Product Note Reconfirmed 2007
    Publisher American Society for Testing and Materials
    Status Withdrawn
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020)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)

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 10011-3:1991 Guidelines for auditing quality systems Part 3: Management of audit programmes
    IEEE 1074-2006 IEEE Standard for Developing a Software Project Life Cycle Process
    IEEE 1008-1987 IEEE Standard for Software Unit Testing
    IEEE 610 : 1991 COMPUTER DICTIONARY - A COMPILATION OF IEEE STANDARD COMPUTER GLOSSARIES
    IEEE 828-2012 IEEE Standard for Configuration Management in Systems and Software Engineering
    ISO 10011-1:1990 Guidelines for auditing quality systems Part 1: Auditing
    IEEE 830-1998 IEEE Recommended Practice for Software Requirements Specifications
    IEEE 729-1983 IEEE Standard Glossary of Software Engineering Terminology
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
    ISO 10005:2005 Quality management systems Guidelines for quality plans
    ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
    ISO 9004-2:1991 Quality management and quality system elements Part 2: Guidelines for services
    ASTM E 1639 : 2001 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (Withdrawn 2002)
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO 9001:2015 Quality management systems — Requirements
    IEEE 1012-2012 IEEE Standard for System and Software Verification and Validation
    IEEE 1063-2001 IEEE Standard for Software User Documentation
    ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    IEEE 1058.1-1987 IEEE Standard for Software Project Management Plans
    IEEE 829-2008 IEEE Standard for Software and System Test Documentation
    ISO 10007:2017 Quality management — Guidelines for configuration management
    ASTM E 919 : 1996 Specification for Software Documentation for a Computerized System (Withdrawn 2000)
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
    ISO 10011-2:1991 Guidelines for auditing quality systems — Part 2: Qualification criteria for quality systems auditors
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