Maintaining the principles and framework of the first edition published in 2008, the much-anticipated ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition):

• Provides updates to applications in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation
• Highlights the importance of applying “critical thinking” by knowledgeable and experienced SMEs when defining the appropriate approach for specific circumstances
• Discusses current FDA activity on Computer Software Assurance (CSA) approaches and clear links to ISPE GAMP® guidance on Data Integrity (DI)
• Expands Appendices to incorporate new and evolving topics in the life-sciences industry such as blockchain, Artificial Intelligence/Machine Learning (AI/ML), cloud computing, and Open-Source Software (OSS)

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