Validation of Computerized Analytical Systems
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Author_Ludwig Huber
Automated Data Collection Systems
Category=UL
change control procedures
Chromatography Data System
Chromatography Software
Computer System Audits
Computer System Validation
Computerized Analytical Systems
electronic records management
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Error Handling
FDA Audit
FDA Investigator
GLP Principle
GLP Regulation
GLP Study
Good Automated Laboratory Practices
Hardware Validation
Hewlett Packard ChemStations
HPLC Module
HPLC System
laboratory compliance
laboratory system validation guide
LIMS
network qualification
quality control processes
regulatory documentation
Software Development Standards
Software Validation
Standard Applications Software
System Suitability Testing
UV Visible Detector
VDE
Product details
- ISBN 9780935184754
- Weight: 650g
- Dimensions: 178 x 254mm
- Publication Date: 31 May 1995
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
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Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.
International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Huber, Ludwig
