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This guide describes an approach to the validation process for a Laboratory Information Management System (LIMS).
Formerly under the jurisdiction of Committee E13 on Molecular Spectroscopy and Separation Science, this guide was withdrawn in September 2015. This standard is being withdrawn without replacement due to its limited use by industry.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E622 Guide for Developing Computerized Systems (Discontinued 2000)
E623 Guide for Developing Functional Requirements for Computerized Systems
E624 Guide for Developing Implemention Designs for Computerized Systems
E627 Guide for Documenting Computerized Systems (Discontinued 2000)
E919 Specification for Software Documentation for a Computerized System (Discontinued 2000)
E1013 Terminology Relating to Computerized Systems
E1384 Practice for Content and Structure of the Electronic Health Record (EHR)
E1578 Guide for Laboratory Information Management Systems (LIMS)
E1639 Guide for Functional Requirements of Clinical Laboratory Information Management Systems
ASTM E2066-00(2007), Standard Guide for Validation of Laboratory Information Management Systems (Withdrawn 2015), ASTM International, West Conshohocken, PA, 2007, www.astm.orgBack to Top