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CLSI AUTO13

Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring, 2nd Edition

This document identifies important factors that designers and laboratory managers should consider when developing new software-driven systems and selecting software user interfaces. Also included are simple rules to help prepare validation protocols for assessing the functionality and dependability of software.  

This document is available in electronic format only.

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Details

Chairholder: Paul J. Mountain, MSC, MT(ASCP)

Date of Publication: February 18, 2003

Order Code PDF: CLSI AUTO13A2E
ISBN Number: 1-56238-484-8

Order Code Print: print not available

Edition: Second

Pages: 88

CLSI AUTO13 Additional Details

If interested in ordering larger quantities of this document in print, please contact us here.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document was formerly sold under the code GP19.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI AUTO13 Abstract

Clinical and Laboratory Standards Institute document AUTO13-A2—Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition provides user interface design recommendations that make new software programs easier for laboratory personnel to learn and use. Additionally, the guideline addresses the preparation and execution of validation plans for software purchased from manufacturers; custom software commissioned by the laboratory; or in-house applications developed to collect, interpret, or report laboratory, patient, or quality control information.