Every validation package holds hard-won knowledge. It records how a team tested a system, set acceptance criteria, and resolved problems along the way. On paper, that knowledge often stops circulating the day the package is approved. It moves to the archive.
That challenge anchored an ASQ Quality Talk Live panel on digital validation, Amanda Santos, engineering commissioning and qualification lead at Kenvue, joined Warren Ware, validation engineer at Colgate-Palmolive. Both described how digital validation changed access to what their teams already know.
The archive problem
Paper brings heavy binders, attachments, and manual routing. It also brings a quieter cost. Amanda explained it this way: “Once you create documents and paper, they go to archival. And then that knowledge and that expertise is kind of lost. It’s very difficult to retrieve it.”
Scale makes the problem larger. Colgate-Palmolive has about 20 facilities on Kneat. When Warren arrived at his current site, he found a siloed model. One engineer owned each building and completed its validations alone. Without a shared view, teams solve similar problems more than once, and good work stays in one building.
Reuse starts with access
For Amanda, the first driver was a single system. Kenvue wanted every document in one place, created and executed in a consistent way, and easy to search. That foundation lets a team find its own past work and learn from other sites doing something similar.
Warren described what that means in practice. A global template gives a high-level starting point, but specific equipment and systems need more detail. If another facility has validated something similar, he can contact that site, copy relevant sections from the approved document, and change the site-specific details. A well-executed, approved document from a peer site also supports accuracy.
His time in the analytical lab shows the contrast. Starting a new validation on paper meant finding the last paper version and then rewriting much of it. Digitally, he can copy and insert content from a completed validation, including one his own site finished last year.
A library that grows with every validation
Entities are core to how modern validation teams manage data — but migrating and maintaining them has Reuse compounds over time. As Warren put it, “The more Kneat facilities you have, the more validations you have, the more that the knowledge base and template base and information base grows.”
The knowledge goes beyond documents. Warren built a calibration master database in Kneat Gx, using entities to hold each piece of equipment, its schedule, and its calibration certificates. He later applied the same framework to computer system validation, using entities for systems, requirements, and risks. One team’s design became a pattern for another discipline.
Shared knowledge needs shared structure
A shared library only helps if people can find and trust what is in it. Colgate-Palmolive learned this firsthand. Sites started with broad freedom to create templates, which produced a very large library. Warren said novice users struggle to tell which templates are globally approved and which are site-specific.
For computer system validation, the team now requires one global template for each deliverable, matched to the global standard operating procedure (SOP). A new engineer with a basic understanding of the discipline can follow the template and produce a robust document. Sites can still build on it.
Kenvue took a different path from day one. Amanda said the organization standardized its processes first, then digitized the standardized templates. Users can add or remove content as long as it aligns with the procedure. “Once you have the base that is similar for everyone, then it’s easier for you to come and get what you need.” For Kenvue, she said, “making stuff in silos was not an option.”
Access changes how people work
Amanda expected agility from digital validation, including faster reviews. She did not expect the change in behavior. Within about two years, people started asking who else had done similar work, looking for a comparable protocol, and contacting the author to learn how it was done. The goal, in her words, is to “do something cleaner, better, faster.”
Collaboration also changed within a single document. Reviewers and approvers can see the same document at the same time and give real-time feedback. No single copy sits on one desk.
Teams also spend less effort creating and moving documents. That frees attention for improvement. Reviewers can ask whether test cases are effective and requirements are met, instead of checking pages for good documentation practice (GDP) errors.
What to take from the conversation
- Treat approval as the start of a document’s useful life. Searchable, approved work gives the next project a head start.
- Standardize before you scale. Clear global templates keep reused content easy to find and trust.
- Keep creation, execution, and search in one system. Knowledge is only useful when people can reach it.
- Prepare for new habits. Reaching out to colleagues at other sites becomes part of the workflow.
Asked for their biggest takeaway, Warren named efficiency and cross-functional teamwork. Amanda named agility and a foundation for new ways of working. Both point to the same idea. Digital validation does more than remove paper. It makes what an organization has learned available to the next person who needs it.
