In pharmaceutical manufacturing, transformation often runs into friction where work is most heavily documented in logbooks and forms. These records are everywhere: on paper, in spreadsheets, or siloed digital systems, and they’re tightly tied to compliance. Yet despite being critical to operations, they’re often the last to scale digitally. Across the industry, three challenges come up again and again: validation cycles that limit agility, fragmented systems that increase risk, and compliance constraints that make small changes feel high-stakes. While AI and automation dominate headlines, foundational processes like logbooks still lack the structure for scalable, compliant change.
At Ops Calling 2025, Eli Lilly shared how they tackled this challenge across 17 global sites. Instead of digitizing thousands of forms one by one, they developed a validated framework for creating, approving, and executing digital logbooks, enabling scale without revalidating each form. With clear governance and standardization, they moved faster, maintained compliance, and surfaced cleaner, more usable data.
This article builds on that example to explore how pharmaceutical manufacturers can approach digital logbooks differently, focusing on standardization, governance, and system-level design to enable compliance at scale.
Why Digital Logbooks Don’t Scale by Default
Pharma teams often start by digitizing logbooks, i.e., replacing paper with dropdowns, text fields, and e-signatures. But without a consistent structure underneath, even digital forms can quickly become unmanageable. Each site ends up with its own version, validation takes longer with every change, and there’s no easy way to keep forms aligned across teams. The result is a digital setup that’s just as fragmented as the paper one it replaced, only harder to update.
“We validated the apps. We have a validated data model that’s sitting behind this….But the business can then take these applications and start building their forms following their SOPs… so they can be building their forms which are then compliant to our data model… and are validated….We feel it really helps us get to this idea of citizen development within Tulip,” where “apps are created in a good way… flexible enough for frontline teams, structured enough for QA.” - John Clark, Systems Engineer, Eily Lilly
Building the Foundation for Scalable Digital Logbooks
Scaling digital logbooks isn’t just about moving faster, it’s about moving smarter. That begins with understanding what’s already in place, and where structure can replace one-off fixes.
Step 1: Categorize Existing Forms to Find Patterns
The path to scalable digital logbooks starts with visibility. Before designing any apps, some teams begin by physically printing and reviewing hundreds of existing paper forms from across their sites. The goal is to understand how the forms actually work.
Teams lay the forms out in a room and group them by:
Structure - sequential steps vs. hierarchical inputs
Input types - checklists, free text, dropdowns, barcode scans, SPVs
Verification needs - whether the form requires second-person verification
Associated artifacts - equipment, materials, rooms, or batch records
This categorization exercise often uncovers surprising commonality: while the content varies, many forms follow the same underlying logic. For example, dozens of forms might follow a simple checklist pattern with a few text entries and a final signature. Others may require hierarchical steps with attachments or sample points.
"We didn’t group by use case, we grouped by how the form functioned.... That’s what allowed us to define what our system actually needed to support." – Julian Witrock, Associate Director, Associate Director, Frontwell Solutions
From this process, teams can define a handful of subgroups that represent a large portion of their use cases. These subgroups then inform the requirements for the first release of a dynamic logbook system, targeting the 10–15% of forms that can be digitized quickly, within a common structure.
By starting with structure and not content, teams are able to:
Define clear, limited task types to support
Create reusable logic for inputs and approvals
Focus validation effort where it has the most impact
It’s a method any regulated organization can adopt: print, sort, group, and look for patterns. Before jumping into digitization, make sure you understand what you're solving for and how often those problems repeat.
Step 2: Build a Framework Using Three Core Apps
Once teams understand the patterns in their forms, the next step is to build a system that supports those patterns at scale. This doesn’t mean coding a new app for every logbook, but creating a small set of tools with clear roles and logic that can handle most use cases.
In practice, that often means building three core apps:
A builder, where users create structured digital forms using pre-defined task types
An approver, where QA or quality leads review and version-control forms before release
A runner, where operators access and complete forms consistently on the shop floor
This structure allows teams to move quickly without increasing compliance risk. The framework is validated once, and new forms created within it don’t require revalidation. Input types are limited, behavior is predictable, and execution follows consistent rules.
By separating creation, approval, and execution, teams build a repeatable process and not a one-off product. It’s a scalable way to manage digital logbooks across sites without adding complexity.
Step 3: Add Guardrails to Keep Form Creation Safe
Once you have a working framework, the next challenge is keeping things under control, especially when you open form creation up to more people. That’s where guardrails come in. Not rules for the sake of rules, but simple structures that make it easier to move fast without cutting corners.
In most cases, those guardrails look something like this:
Who can do what is clearly defined, so builders, reviewers, and approvers each know their role
The system only offers pre-approved task types, so no custom logic, no surprises during validation
Smart checks are built in, so you can’t skip a required field or move forward without a signature
Quick SOPs or reference guides help people use the system without second-guessing every step
When this setup is in place, teams don’t need to chase approvals or check every detail manually. They build within a structure that’s already been validated. And that’s the point: guardrails give teams confidence to build, without putting extra pressure on QA or IT.
“It’s like working inside a “validated sandbox”. You’ve got room to move, but you’re not stepping outside the lines.” - John Clark, Systems Engineer, Eily Lilly
The result is what every ops and quality leader wants: teams on the ground can respond to real issues as they come up, and QA can trust that everything being built is still compliant. It’s structure that helps, not slows.
Step 4: Centralize Ownership, Support Local Execution
Once the framework is in place, keeping it aligned across teams becomes just as important as getting it up and running. That starts with assigning clear ownership and not just for individual forms, but for the system as a whole. When this structure is in place, local sites can move quickly without creating chaos.
Here’s what that looks like in practice:
A central team owns the builder, approver, and runner apps
Any changes to the framework follow a structured, version-controlled process
Updates are tested, validated once, and then shared across the network
Local teams use the latest version, but stay within clearly defined guardrails
In some setups, the framework is published to an internal marketplace, so sites can download approved tools on their own. This avoids long dev cycles and helps teams start building faster, without compromising structure.
Regular check-ins, whether through monthly governance reviews or cross-site working groups, keep everything connected. They help teams share what’s working, flag what needs fixing, and stay aligned as the system evolves.
This kind of governance avoids version drift, reduces rework, and gives both QA and ops a consistent foundation to build on, no matter how many sites are involved.
Operational Benefits of Scalable Digital Logbooks
When digital logbooks are designed to scale, from the structure of the apps to the way they’re governed, teams move faster, with more clarity, more consistency, and fewer surprises.
Instead of starting from scratch every time, they reuse what already works. Forms don’t drift from site to site. QA doesn’t have to review the same logic over and over. Local teams can adapt quickly, and global teams stay confident that everything stays aligned.
The benefits show up fast:
Faster rollouts that don’t get stuck in validation cycles
Less rework across sites and functions
Cleaner data that’s ready for inspection or analysis
Better collaboration between QA, IT, and operations
And maybe most importantly, logbooks stop being a bottleneck. They become a tool for visibility, standardization, and continuous improvement, one that fits naturally into broader digital transformation efforts.
This shift is already happening. Across pharma, the organizations moving fastest aren’t just digitizing forms. They’re building systems that make good practices easier to scale, and turning compliance into a foundation for speed.
How Tulip Supports Scalable Digital Logbooks
Tulip is a human-centric digital operations platform built for regulated industries like pharma. With built-in compliance guardrails, flexible deployment options, and seamless integration across systems, Tulip gives quality and operations teams the structure they need to scale digital logbooks confidently. Whether teams are adopting Validation 4.0 practices or enabling citizen development within a governed framework, Tulip supports the shift from one-off forms to audit-ready systems, without adding risk.