Engaged. Knowledge. Application
Computer Validation Requirements CONTENT Package
Package includes a webinar recording with powerpoint presentation and an article by industry experts:
➢ 1. Requirements: Your Foundation for Conducting Successful Computer Systems Validation (One Hour Webinar Recording)
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here to view complimentary excerpt
➢ 2. and 3. Requirements: Your Foundation for Conducting
Successful Computer Systems Validation (PowerPoint Training
Presentation and Trainer Instructional Notes)
➢ 4. Considerations in Writing More Effective Computer Validation Requirements (Article)
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here to view complimentary excerpt
1. 2. and 3. Requirements: Your Foundation for Conducting Successful Computer Systems Validation (One Hour Webinar Recording, PowerPoint Training Presentation and Trainer Instructional Notes)
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here to view complimentary excerpt
Serves as an invaluable guide to critical aspects of defining and developing a requirements specification related to conducting effective computer systems-related validations.
“Requirements are the single most fundamental part of a computer system validation project, as they determine the scope, level of effort, schedule and resources that will need to be involved in the validation.”
Subject matter content reviewed includes:
➢ Computer system definition
➢Computer system validation lifecycle
➢Why requirements
➢Planning is everything
➢Requirement types
➢Requirements definition
➢Fundamental qualities of requirements
➢Requirements language
➢Requirements analysis
➢Sources of requirements
➢Factors influencing requirements
➢Contributors
➢Creating (or extracting) requirements
➢Risk implications
➢Traceability
➢Change control
➢Configuration management
Instructors: Jay King, Senior Manager, Software and New Product Quality at LifeScan, a Johnson & Johnson Company
John Janeri, President, Compliance House, Inc.
*Powerpoint Presentation Notes are comprehensive. Reads like a reference article.
4. Considerations in Writing More Effective Computer Validation Requirements (Article)
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This eight-page article reviews a number of critical issues related to writing effective computer validation requirements. Several examples are presented throughout the article. Subject matter content includes:
➢Structuring requirements
➢Level of detail
➢Pseudo-code
➢Intended use
➢Diagnostics
➢Quality content
➢Design input/automated processes
➢Relationship of requirements
➢Indicating where requirements are met
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