CLSI I/LA33 P : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION
12-01-2013
30-12-2009
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Superseded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 |
| CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |