The International Society for Pharmaceutical Engineering (ISPE) has long been the leader in promoting best practices designed to make life sciences companies more efficient and products safer. In April 2025, the ISPE released their definitive guide on Digital Validation Tools (DVTs) to help companies understand why now is the best time to adopt a digital validation platform.
What is digital validation?
The idea of digital validation has been on the ISPE’s radar for years, featuring so strongly in their Pharma 4.0 methodology that they coined the term Validation 4.0 to address the emerging capabilities made possible by technological advancements. It, at a high level, refers to validation processes that have been digitalized away from paper. Discussed in Kneat’s 2025 Digital Validation Handbook, there are several types of digital validation, including:
- Paper-to-glass:
- Such as scanning documents
- Paper-to-digital
- More functional capabilities mirroring paper-based documents
- Hybrid digital validation
- Processes that are both paper and digital
- Complete digital validation
- Entirely digital validation processes
What are DVTs?
Digital validation tools are assets that enable an organization to perform digital validation. Commonly, DVTs come in the form of a platform, such as Kneat Gx. Platforms can provide a wide range of capabilities to enhance digital validation beyond simply eliminating paper.
What’s in the ISPE’s guide?
The ISPE Good Practice Guide: Digital Validation aims to increase adoption of DVTs in the industry to further improve data integrity, efficiency, and compliance. Authored by leading minds in the validation sector, the guide is a useful tool to help those considering leveling up their validation processes.
What experts want you to know
Kneat assembled two of the guide’s authors, Dave O’Connor and Phil Jarvis for a webinar to give a hands-on look at the new good practice guide. Joined by Kneat’s digital validation expert, Emma Carey, the webinar explored key insights and gave the audience an opportunity to dive deeper into questions and see how the leading DVT, Kneat Gx, delivers on the promises of the guide.
You can watch the webinar on demand right here!
Some of the questions discussed in the webinar are described below:
Q: Do DVTs include continuing validation activities? If we have additional reviews intermittently to maintain a validated state, is this captured?
A: A comprehensive DVT is able to address continuing validation. For example, Kneat’s Periodic Review functionality allows users to set deliverable dates for systems, equipment, or even documentation. The platform will flag reviews if overdue and show statuses such as ongoing or upcoming.
Q: How are DVTs themselves validated?
A: Since they’re used in production, DVTs will face validation requirements in line with GAMP practices. DVT providers should be able to provide a fully validated system as part of implementation. For example, Kneat delivers IQ/OQ reports along with approved configuration documents as well as sample System Acceptance Testing (SAT) documentation. Each new release is supported to ensure Kneat remains in a validated state.
Q: Do DVTs support audits?
A: Yes, DVTs should be able to support audits or inspections. In fact, they make them considerably easier by enabling a managed delivery of relevant documents to inspectors. In Kneat, the Collections Area functions as a virtual War Room, which houses pre-approved documentation and their attachments for easy access by investigators.
Explore the guide for yourself
As the premier DVT — used by 8 of the Top 10 global Life Sciences organizations — Kneat encourages validation and quality professionals to explore the ISPE Good Practice Guide. In addition to the webinar, we’ve also created our own guide to support your understanding of DVTs and the value of digital validation to your organization.
You can download that here!
