CLSI AUTO08

Managing and Validating Laboratory Information Systems, 1st Edition

This document provides guidance for developing a protocol for validation of the laboratory information system (LIS), as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

This document is available in electronic format only.

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Chairholder: Sandy Pearson, MT(ASCP)

Date of Publication: December 15, 2006

Order Code PDF: CLSI AUTO08AE
ISBN Number: 1-56238-624-7

Order Code Print: print not available

Edition: First

Pages: 74

CLSI AUTO08 Additional Details

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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 AUTO08 Abstract

Clinical and Laboratory Standards Institute (CLSI) document AUTO08-A—Managing and Validating Laboratory Information Systems; Approved Guideline identifies important factors that laboratory managers should consider when developing a protocol for the validation of the laboratory information systems (LIS). Also included are recommendations to help prepare validation protocols for assessing the accuracy and dependability of the LIS in storing, retrieving, and transmitting data.