A01=Orlando Lopez
Applicable Predicate Rule
audit
Author_Orlando Lopez
Category=P
CFR
Code Reviews
computer
Computer Systems Validation
Computer Technology Supplier
Computer Validation
Configurable Software Packages
Contract Developer
control
Corrective Action Plan
CSV
Current Good Manufacturing Practice Regulations
digital signature technology
electronic
Electronic Record
Electronic Signature Security
encryption methods
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
Fat
FDA regulatory compliance
Follow
In-process Audits
Message Digest
Ongoing Monitoring Program
PDA
pharmaceutical computer validation guide
pharmaceutical software validation
plan
Private Key
procedural
Program Build
quality assurance systems
records
signatures
SLC
Software Life Cycle Processes
Standard Software Packages
system lifecycle management
systems
validation
Validation Plan
Product details
- ISBN 9780849322433
- Weight: 612g
- Dimensions: 178 x 254mm
- Publication Date: 15 Jan 2004
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
Secure
checkout
Fast Shipping
Easy returns
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
López, Orlando
