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ISPE ISPE Good Practice Guide: Digital Validation

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This Guide considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support a growing commitment to data integrity, operational efficiency, and regulatory compliance. However, the transition from traditional, paper-based validation to a digitally integrated framework remains a complex challenge.This Guide offers practical guidance and best practices for navigating the complexities of implementation and operation.Developed by a global team of experts in validation, regulatory compliance, quality assurance, and digital transformation, this Guide presents real-world insights, case studies, and structured methodologies to facilitate the successful integration of digital validation into business operations. It explores regulatory considerations, system selection, data management strategies, and compliance frameworks, providing organizations with the necessary tools to enhance validation efficiency while maintaining regulatory rigor.

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