Author: Publisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems Withdrawn 2002
Author: Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
Author: American society for testing and materials. Subcommittee E31.13 on Clinical laboratory systemsPublisher:
ISBN:
Category :
Languages : en
Pages : 28
Book Description
Annual Book of ASTM Standards
Author: ASTM InternationalPublisher:
ISBN:
Category : Materials
Languages : en
Pages : 604
Book Description
Standard Guide for Selection of a Clinical Laboratory Information Management System
Author: National Committee for Clinical Laboratory StandardsPublisher:
ISBN:
Category :
Languages : en
Pages : 46
Book Description
ASTM Standardization News
Author: American Society for Testing and MaterialsPublisher:
ISBN:
Category : Standardization
Languages : en
Pages : 862
Book Description
Standard Guide for Selection of a Clinical Laboratory Information Management System
Author: Clinical and Laboratory Standards InstitutePublisher:
ISBN: 9781562384913
Category : Medical laboratories
Languages : en
Pages : 39
Book Description
Standard Guide for Validation of Laboratory Information Management Systems Withdrawn 2015
Author: Validation of Chromatography Data Systems
Author: Robert McDowallPublisher: Royal Society of Chemistry
ISBN: 1847552293
Category : Science
Languages : en
Pages : 289
Book Description
Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
Pre-Examination Procedures in Laboratory Diagnostics
Author: Walter G. GuderPublisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110390191
Category : Medical
Languages : en
Pages : 493
Book Description
The preanalytical phase is an important component of Laboratory medicine and errors arising in this phase affect the validity of laboratory results. In this book physicians and clinical staff have access to valuable information about the current preanalytical variables and factors (patient preparation, sample collection, handling and processing before analysis).
Performance Standards for Antimicrobial Susceptibility Testing
Author: CDC.Publisher:
ISBN: 9781562388041
Category : Microbial sensitivity tests
Languages : en
Pages : 250
Book Description
"This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8"--Cover.