ISPE’s Good Practice Guide is out — and No deviation Is Proudly Involved

Digital Validation Takes Center Stage

April 2025 marks a major milestone in the pharmaceutical and life sciences industries: the publication of ISPE’s Good Practice Guide: Digital Validation. This long-anticipated resource provides clear, actionable guidance on transitioning from traditional paper-based validation to fully integrated Digital Validation Tools (DVTs).

At No deviation, we’re particularly proud of this release — because our very own Dave O’Connor, C&Q Digital Transformation Manager, is among the contributors who brought this guide to life.

Why this guide matters

Digital validation is no longer a futuristic concept — it’s fast becoming the new normal. But the shift toward digitization is complex. From system selection to regulatory compliance, and from business case justification to long-term governance, successful implementation requires more than just software. It demands vision, structure, and alignment across functions.

That’s where this ISPE guide comes in.

Key topics covered include:

• Building the business case for digital validation
• Implementing DVTs using the GAMP approach
• Establishing governance models for long-term management
• Understanding the regulatory frameworks that support digital solutions

Structured around real-world experience and best practices, the guide has been developed by a global team of experts in validation, digital transformation, QA, and regulatory compliance — including leaders from GSK, Takeda, VEQTOR, CAI, PSC Biotech, Compliance Group Inc., and more.

No Deviation’s contribution

Dave O’Connor’s participation in this project reflects No deviation’s continued commitment to innovation and leadership in digital CQV (Commissioning, Qualification, and Validation). His experience in guiding clients through complex digital transitions helped shape the content of this guide — ensuring it is not only practical but also grounded in day-to-day realities.

We believe this guide is a must-read for anyone involved in validation, quality, or digital transformation in the life sciences. It provides valuable insight into how to address the challenges and seize the opportunities of digital validation.

Join the conversation

Want to learn more?

• Meet the contributors and explore the guide further at the ISPE London Conference on May 14.
• Or join No deviation’s Digital Day in Belgium on May 15, where digital CQV will take center stage.

The future of validation is digital — and we’re proud to be shaping it.

For more information or to discuss how digital validation could transform your organization, don’t hesitate to hello@nodeviation.com.

Interested in getting the guide?

You can purchase the ISPE Good Practice Guide: Digital Validation directly from the ISPE website — available to both members and non-members.