[Book] "Guidelines for Implementing Computer Validation in Compliance with GAMP5, FDA, and ANNEX 11" [Non-designated product by our company]
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[Book] "Guidelines for Implementing Computer Validation in Compliance with GAMP5, FDA, and ANNEX 11" [Non-designated product by our company]
Author: Koichi Murayama, President, eCompliance Inc. Subject: General CSV-related topics Publisher: eCompliance Inc. Publication: Now on sale Stock: Confirmation required Format: 92 pages
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Author: Koichi Murayama, President, eCompliance Inc. Subject: General CSV-related topics Publisher: eCompliance Inc. Publication: Now on sale Stock: Confirmation required Format: 92 pages
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Chapter 1: What is Computerized System Validation Chapter 2: Trends in Regulatory Requirements and Guidelines for CSV Chapter 3: Overview of GAMP 5 Chapter 4: Differences Between GAMP 4 and GAMP 5 Chapter 5: Risk-Based Approach Chapter 6: Approach to Specifications and Verification Chapter 7: Types and Attributes of Deliverables Chapter 8: Utilizing Suppliers Chapter 9: Lifecycle Phases Chapter 10: Overview of the System Lifecycle (SLC) Chapter 11: Business Process Map Chapter 12: Roles and Responsibilities Chapter 13: Skill Sets Chapter 14: Planning Phase Chapter 15: Requirement Phase Chapter 16: Design Phase Chapter 17: Build Phase Chapter 18: Test Phase Chapter 19: Deployment Phase Chapter 20: Use Phase Chapter 21: Retirement Phase Chapter 22: Cross Phase Chapter 23: Deliverables and Categories
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Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.