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.

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Publication Details

Chairholder: Sandy Pearson, MT(ASCP)

Date of Publication: December 15, 2006

ISBN Number: 1-56238-624-7

Order Code PDF: AUTO08AE

Order Code Print: AUTO08A

Edition: First

Pages: 74

AUTO08 Additional Details

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 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.