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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.