CLSI AUTO10 P : 1ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
31-10-2006
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Design of Algorithms
4.1 Data Elements
4.2 Algorithm-Based Decisions
4.3 Reporting of Results
4.4 Selective Suppression of Auto verification
5 Regulatory Compliance
5.1 Statutory Obligation
6 Validation of Algorithms
6.1 Logic
6.2 Independent Data Observations/Collection
(monitoring of data in/data out)
6.3 Algorithm Updates
6.4 Software Updates
6.5 Validation Tools
6.6 Periodic Revalidation
References
Additional References
The Quality System Approach
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