CLSI I/LA33 P : 1ED 2009
Superseded
Superseded
View Superseded by
VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION
Published date
01-12-2013
Publisher
Superseded date
12-30-2009
Superseded by
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Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Immunohematology Tests and Automated Systems
5 Validation Process
6 Materials (Reagents, Equipment, and Supplies
7 Installation Qualification
8 Operational Qualification
9 Performance Qualification
References
Appendix - Sample Templates and Test Cases
The Quality Management System Approach
Related CLSI Reference Materials
Specifies guidance to the end user and laboratory for validation of automated systems used in immunohematologic testing prior to implementation.
| DocumentType |
Proposed Guideline
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI AUTO8 A : 1ED 2006 | MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS |
| CLSI QMS03 A3 : 3ED 2009 | TRAINING AND COMPETENCE ASSESSMENT |
Summarise
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