Good Practice Guide: Digital Validation
Published: April 2025
Pages: 90
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.
Digital Validation White Papers
Members of the ISPE C&Q Community of Practice have authored the following white papers that provide additional information on the topic covered in this Guide.
Digital Validation – Use Cases, Challenges, Standards, and Regulatory Guidance
Digital Validation – Future Advances
Conference Session
Digital Validation Mastery: Enabling Validation 4.0 - (Video)
The presentation, presented at the 2025 ISPE Europe Annual Conference, provides an overview of the ISPE Good Practice Guide: Digital Validation. The presenters discuss how to implement digital validation within an organization, enhance efficiency and compliance in validation processes, address key regulatory considerations, and more.
Content includes:
- Key digital validation concepts, such as how to achieve data integrity by design, and true copy practices with digital validation tools
- Creation of business cases for digital validation—by enhancing efficiency and compliance in validation processes, while increasing knowledge management
- Implementation and governance of digital validation systems, including effective implementation and validation strategies, shifting to a digital validation mindset, how to avoid “paper on glass”, and adopting a data-centric instead of document-centric mentality
- Key regulatory considerations, including recommendations for digital validation use in audits and maintaining robust data integrity
- The presentation discusses where we are currently with digital validation systems in the industry and future advancements that will support a comprehensive digital ecosystem that enables validation 4.0 principles, via integration with other systems and advanced technologies such as AI/ML
Guide Core Team
For the full list of contributors to this Guide see Guidance Document Teams