New ISPE Good Practice Guide Helps Pave the Way to Digital Validation (2025)

As organizations move towards digital validation of C&Q, they often face obstacles with implementation, governance, system integration, and regulatory adherence. The evolving landscape of global regulations, the variety of available technologies, and the heightened auditor expectations further complicate this transition, making structured guidance and industry-wide collaboration essential.

The industry has had access to DVTs for a long time, but these have finally come to realization in the last few years thanks to advances in technology. As people have started the process of moving from a paper-based to digital-based validation, there were a lot of questions about how to manage the processes, how to best leverage the tools, and many people were looking for guidance on what to do and how to do it.

Mark Drinan, Small Molecule Operational Unit Lead, Commissioning, Qualification, and Validation with Takeda, Guide Co-Lead.

The ISPE Good Practice Guide: Digital Validation offers practical, risk-based best practices for defining, implementing, and managing DVTs within a regulated environment. 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, equipping organizations with the necessary tools to enhance validation efficiency while maintaining regulatory rigor.

Both Phil, myself, and some other members of the Guide team has been through rollouts of DVTs. Successfully implementing a digital validation strategy requires more than just technology - it demands a cultural shift, cross-functional collaboration, and alignment with organizational objectives. You do not just want to switch to paper on glass; you have to think digitally. In this Guide we discuss how to foster a shared understanding among quality professionals, validation experts, regulatory authorities, and technology providers, to ensure a holistic approach to digital validation. It will serve as an essential reference for organizations at all stages of their digital validation journey, whether they are beginning their transition or seeking to optimize existing systems. Even if you already have DVT in place, this Guide can help you make it better.

Mark Drinan

DVTs offer real-time visibility of progress including immediate updates on documentation status, eliminating the need for traditional manual tracking. They offer the ability to link requirements/critical design elements (CDEs) directly to verification tests, streamlining document creation, review, and report generation as well as enabling faster system handovers. “We successfully set up a DVT system at AbbVie and it was very favorably received by auditors. If you are looking to drive innovation and create a more efficient process, digitizing validation is your first step,” said Jarvis.

This Guide can help you get to the last step of an old paper-based process and take your first step on a new journey to full digitalization.

Mark Drinan

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