advanced pharmaceutical system validation
Business Process
Category=UY
CDS
change
companies
Computer System Validation
Computer Validation
control
Cot
CRC Press LLC
EDMS
electronic
Electronic Records
electronic signature compliance
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eq_computing
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
findings
GAMP Category
GxP Assessment
GxP Regulatory Authorities
healthcare
Healthcare Companies
inspection
laboratory automation systems
Life Cycle
LIMS
pharmaceutical informatics
planning
process analytical technology
recent
RECENT INSPECTION FINDINGS
records
regulatory audit processes
Risk Assessment
risk-based validation
RTM
SCADA System
Source Code Review
Supplier Audit
User Requirement
User Requirement Specification
Validation Life Cycle
Validation Plan
VMP
Product details
- ISBN 9780849318719
- Weight: 2070g
- Dimensions: 178 x 254mm
- Publication Date: 18 Dec 2003
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
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Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.
The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
