Managing and validating laboratory information systems

06-Feb-2015 06:50

Withdrawn Rationale: This guide describes an approach to the validation process for a Laboratory Information Management System (LIMS).

Formerly under the jurisdiction of Committee E13 on Molecular Spectroscopy and Separation Science, this guide was withdrawn in September 2015.

"LIS" has tended to refer to laboratory informatics systems in the forensics and clinical markets, which often required special case management tools.

"PDES" has generally applied to a wider scope, including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.

A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based laboratory and information management system with features that support a modern laboratory's operations.

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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.

ASTM Standards 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 is a member of Cross Ref.