The life sciences industry continues to evolve rapidly, and validation practices must evolve with it. The newly published ISPE Good Practice Guide: Digital Validation represents a significant step forward in supporting organizations on their journey. It provides practical direction for moving from paper-based systems to digital-first validation, with a focus on governance, data integrity, and cultural change.
Transitioning to digital validation is not just about technology – it is about rethinking processes, strengthening collaboration, and building confidence in compliance. The guide highlights exactly this, offering best practices to help organizations overcome complexity, ensure regulatory alignment, and realize the efficiency gains that digital tools make possible.
A Valuable Milestone for the Industry
The ISPE guide arrives at a pivotal moment. Many organizations are still navigating the shift from traditional, paper-based validation toward digitally integrated processes. Challenges such as system integration, regulatory expectations, and cultural adoption remain top of mind for quality and validation leaders.
By presenting structured, risk-based best practices, the guide provides a clear framework for moving forward. It not only validates the progress made so far but also creates a common reference point for companies at different stages of digital maturity.
InformaIT's Alignment with Best Practices
At InformaIT, we welcome this guidance. We are proud that our solutions already reflect the principles set out in the ISPE guide. From the start, we have designed our technology to enable smarter, faster, and more compliant validation – going far beyond simply digitizing paper processes. Features such as AI-driven OCR, XML input, and seamless integrations directly support efficient workflows, robust data integrity, and readiness for inspection.
Beyond Technology: A Cultural Shift
Just as importantly, we believe that digital transformation is a cultural journey. Change management, cross-functional collaboration, and user adoption are central to how we implement and support our solutions. Our experience shows that the right combination of technology and organizational readiness leads to sustainable results, reduced risk, and measurable business value.
For the industry as a whole, the ISPE guide is an important milestone. It validates the progress already made, sets a clear framework for companies at all stages of digital maturity, and establishes a common language for moving forward together. Whether an organization is taking its first steps into digital validation or optimizing mature systems, this reference will help chart the way.
Looking Ahead with Confidence
As Magdalena Grevfe, Chief Quality Officer at InformaIT, explains: “The new ISPE guide confirms what we at InformaIT have long believed – that digital validation is both a compliance necessity and a driver of quality and efficiency. We are delighted to see industry-wide alignment on practices that truly benefit patients, companies, and regulators alike.”
We congratulate ISPE and all contributors on producing this valuable guide. At InformaIT, we remain committed to supporting our customers in embracing digital validation with confidence and in building a future where validation drives innovation as well as compliance.
