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Special Edition: Computer & Software Validation
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Item Number: IVTZCSV
Compiled from articles published by the Journal of Validation and the Journal of GXP Compliance, this resource guide discusses issues associated with computer validation in order to provide a useful resource for daily work applications, as well as information regarding regulatory requirements for the validation and qualification of computerized systems.
Articles include:
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Computer System Validation - Definition and Requirements
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Computer System Design
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System Design and Control
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The Nine Most Common Computer Validation Problems
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Accurately Identifying Your Requirements
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Computer Systems Quality and Compliance vs. Software Validation
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Computer Systems Change Control
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How to "Right-Size" Computer System Validation Based on Criticality and Complexity
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Practical Use of Automated Tools in Computer System Compliance
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Selecting and Partnering with a Vendor for a Qualified Software Products
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Information Security
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Disaster Recovery and Business Continuity
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System Definition: Defining the Intended Use for a System
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Lessons Learned in a Non-Regulated Software Validation Project
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Computer Validation in the New-Clear Age
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