Dori Gonzalez-Acevedo is an internationally recognized authority on digital validation, quality culture, and risk-based compliance strategies within regulated industries. She serves as Co-Lead of the ISPE Digital Validation Subcommittee and is a contributing author to the forthcoming ISPE Good Practice Guide on Digital Validation.
As CEO of ProcellaRX, Dr. Gonzalez-Acevedo has led large-scale modernization initiatives that integrate behavioral science, digital transformation, and regulatory alignment to help organizations transition from compliance-driven to trust-centered quality systems.
A frequent global speaker for ISPE, KENX, and other international conferences, she is known for translating complex regulatory and cultural challenges into actionable frameworks that drive meaningful, lasting change in quality leadership and digital maturity across life sciences organizations.
If someone had shared five years ago that industry would still be debating AI governance frameworks inside validation steering committees, it would have seemed unlikely. At the time, many genuinely believed the maturation of digital validation, especially with the publication of the
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional paper-based validation processes to adopt digital validation tools (DVTs). This transition began with electronic validation repositories, enabling the digital creation, uploading, and electronic approval of documentation—securely stored and meeting electronic records and signatures compliance...