Good Practice Guide: Digital Validation

Published: April 2025 
Pages: 90

• Table of Contents
• Special Pricing for Emerging Economies

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.

Guide Core Team

Mark Drinan

Small Molecule OpU Lead, Commissioning, Qualification and Validation

Takeda Pharmaceuticals International AG

Phil Jarvis

Director, Integrated C&Q and Paperless Strategy

VEQTOR Solutions

Graham Cameron

Validation Lead

GlaxoSmithKline

Dori Gonzalez-Acevedo

CEO and Co-Founder

ProcellaRX

Lori Kim

Vice President, Technical Operations

PSC Biotech Corp

Amy Kuntzman

Principal Consultant

CAI

Khaled Moussally

Executive Vice President Clients & Regulatory Relations

Compliance Group Inc

Dave O’Connor

C&Q Digital Transformation Manager

No Deviation

Stephanie White

COO, Quality SME

The Zebra Group

For the full list of contributors to this Guide see Guidance Document Teams