Digital Validation Mastery: Enabling Validation 4.0
ISPE released the ISPE Good Practice Guide: Digital Validation in April 2025. Guide Leads Mark Drinan of Takeda Pharmaceuticals International AG, Phil Jarvis of Grifols, and David O’Connor of No Deviation presented an overview of the Guide at the 2025 ISPE Europe Annual Conference in May, in their session “Digital Validation Mastery: Enabling Validation 4.0.” Watch their presentation below.
Guide Leads
Drinan, Jarvis, and O’Connor discuss key validation concepts, the implementation and governance of digital validation systems, and key regulatory considerations. They also examine the current state of digital validations systems in the industry and what future advancements may look like.
The ISPE Good Practice Guide: Digital Validation details key digital validation-related concepts and terminology to engage stakeholders, a structured approach to assess digital maturity and build a comprehensive roadmap, guidance on managing digital data across systems and teams, and insights to support cross-functional engagement and implementation of digital validation tools.
This Guide is ideal for professionals working in quality assurance, information technology, and validation, as well as decision-makers seeking practical support to implement or expand digital validation within their organizations.
Additional resources to learn more about the Guide include:
- “New Guide Helps Pave the Way to Digital Validation” (Pharmaceutical Engineering® May/June 2025)
- Quality Culture Matters: Key to Unlocking the Digital Validation Power | ISPE | International Society for Pharmaceutical Engineering (ISPE webinar, available to ISPE members )
