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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

ISBN Number: 1-56238-624-7

Order Code Print: print not available

Edition: First

Pages: 74

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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.