Digital SOPs For Pharmaceutical Manufacturers With Tulip

Many times it happens that a line stops and not because of a machines’ fault, but because an operator hesitates mid-task, unsure of the next step. The SOP sits buried in a binder, dense and dated. Work pauses, quality steps in, and production drifts off schedule.

Scenes like this still play out across pharmaceutical plants, even after years of digital investment. Paper-based SOPs are outdated, slow to update, and awkward to validate and it remains a quiet source of risk. They slow audits, create errors, and leave frontline teams uncertain.

For manufacturers bound by GMP and 21 CFR Part 11, that uncertainty is dangerous.

Digital SOPs change the equation. They don’t replace procedures; they make them easier to follow, update, and trust.

Digitizing paper-based operating procedures is one of the easiest ways to improve efficiency and reduce errors on manufacturing lines. For pharmaceutical manufacturers, however, digitizing paper-based processes isn’t always straightforward.

Digital technologies need to meet cGMP guidelines. They must conform to a high standard for data integrity. And they must be secure enough to prevent front-line users from making unintended changes to critical production processes.

Tulip digital SOPs include several features that can help pharmaceutical manufacturers improve efficiency, quality, and visibility in highly regulated facilities. These features are designed to streamline data collection, make compliance a seamless part of the manufacturing process, and secure applications with tightly controlled permissions and approvals.

Similar work instruction applications are already in use in GMP-compliant drug production facilities.

Paper SOPs were built for a slower world. In today’s high-throughput, tightly regulated pharmaceutical operations, they simply can’t keep pace. The problems aren’t always obvious, until something slips.

The weak spots are familiar:

Pages disappear.
Versions drift.
Signatures get skipped.
Updates crawl through review cycles.

And when inspectors arrive, those cracks widen fast. The FDA still lists incomplete or inconsistent SOP records among the top findings in pharmaceutical audits.

Why they struggle:

These aren’t paperwork nuisances—they’re compliance gaps, lost time, and missed opportunities to improve.

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Paper vs. Digital SOPs: What’s the Real Difference?

Even when procedures are followed, paper makes it harder to prove it. Digital SOPs don’t just document the process, in fact they actively support it, guiding operators and ensuring every step is tracked and compliant by design.

Digital SOPs are work instruction applications that guide workers through complex production processes.

Digital SOPs turn difficult-to-read instructions packets into instrumented, interactive workflows. Rich media like photos and videos guide operators through complex procedures. Trigger-based logic automates data collection and progression through a process. And connectivity to IoT devices error-proof processes while increasing visibility.

For manufacturers in all industries, the benefits of digital work instructions include:

• Improved efficiency
• Fewer errors
• Higher throughput
• Better quality
• Higher operator engagement
• Better visibility

Here are some ways Tulip can help pharmaceutical manufacturers with their unique improvements.

Simplified Documentation

Extensive documentation is a fact of GMP compliance. Records are essential for demonstrating that a given drug meets designated quality standards.

Tulip’s digital SOPs automatically document each step of a process. Operator codes provide a record of the individual who executed the process, and a step-based application format provides a time marker for every step completion. All of the information is stored in no-code tables and is easily accessible when needed.

These records can be exported to create a batch record report and provide a record of process execution and validation when combined with electronic logbooks.

Standardization of Procedures Reduces Risk

Paper-based instructions create the opportunity for variation. Even the best-written, clearest SOPs leave a window for individual interpretations.

In highly regulated industries, these individual variations are a significant source of risk.

Digital SOPs remove the chance of variation. With IoT connected in-line quality checks, these SOPs guarantee that workers are performing every step as specified. If errors do occur, in-app error reports let workers document the problem accurately, at the source.

Controlled Permissions

A common concern with no-code platforms is that an end-user might accidentally change a critical setting. In a validated facility, such changes could have unintended, potentially severe consequences.

Tulip digital SOPs tightly control which users have access to which feature. For example, the engineers creating applications on Tulip will have the ability to author and edit applications. If necessary, the highest level of control can be reserved for IT, who are responsible for integrating and administering the platform. The admins can limit end-users’ power in the platform to running applications in production contexts.

This ensures that digital systems are safe, compliant, and suited to local needs.

Better Quality with In Line Reporting

Mistakes and non-conformances will inevitably happen. While it’s important to prevent them, it’s just as important that they’re documented correctly.

Tulip Digital SOPs let operators report errors in line. Engineers can create custom error report forms for each process, enabling workers to provide the necessary information. IoT connected tools like scales, calipers, and cameras, among others, provide an extra level of in line quality.

Data Integrity by Design

Currently, documentation is a paper-based, manual process.

Documenting processes by hand is inefficient, and doing so by hand increases the likelihood of error, illegible entries, or misfiling forms.

Tulip’s automated data collection ensures that data meets the rigorous standards outlined in regulations. It is protected at workstations, in the cloud, or in your on-premise servers, as well as in transit.

To understand the impact that digital SOPs can have on production, it helps to look at an example.

The Challenge

A Fortune 500 pharmaceutical manufacturer introduced a complex piece of continuous manufacturing equipment into their production facility. Using paper SOPs, disassembling and cleaning the line’s 16,000 parts took up to two weeks.

Given the high cost of downtime and the higher cost of mistakes, this manufacturer wanted to decrease the time spent performing line clearance and increase the accuracy of workers.

The Solution

This manufacturer used Tulip to convert their paper SOPs into digital work instructions. These digital work instructions reduced the time workers spent looking for and interpreting the next step.

Previous SOPs were “choose your own adventure” style–meaning that for subtasks, an employee would need to flip back and forth to find the next step. With Tulip digital SOPs, they were able to route to sub-tasks within the application, where the necessary information was immediately available.

By using digital SOPs, this manufacturer reduced their line clearance procedure from two weeks to two days.

In pharmaceutical manufacturing, compliance is the floor. Meeting it means working within a dense network of regulations that govern how procedures are written, followed, and verified. For SOPs, a few frameworks set the tone:

FDA 21 CFR Part 11 – Defines how electronic records and signatures must be managed so they carry the same legal and scientific weight as paper.
GxP – The umbrella for “Good Practice” standards across manufacturing, lab, and clinical activities.
GMP (Good Manufacturing Practice) – Focuses on consistency and control to ensure every batch meets defined quality standards.
ALCOA+ – Establishes the principles of data integrity: records must be Attributable, Legible, Contemporaneous, Original, Accurate as well as Complete, Consistent, Enduring, and Available.

Paper-based SOPs make these expectations harder to meet and even harder to prove during audits. Digital SOPs, when validated correctly, simplify both.

Implementation Roadmap

You don’t have to rebuild everything at once. Most teams start with one or two procedures that cause the most trouble, ones that always seem to create deviations or slow approvals. Once those are running cleanly in Tulip, the rest follow more easily.

Start small
Pick something that hurts every week. It might be a batch record handoff, a cleaning verification, or a packaging check. The goal is to learn the process, not to automate the whole site.

Build the workflow
In Tulip, drag the steps into place, add checks where people often make mistakes, and drop in photos or notes for clarity. Keep the layout familiar so operators don’t need a long ramp-up.

Handle validation early
Use Tulip’s toolkit to line things up with 21 CFR Part 11 and GxP. Document as you go i.e. screenshots, approvals, test results. It saves a lot of cleanup later.

Train and release
Bring the people who run the process into testing. They’ll find what doesn’t make sense before QA does. Training usually takes a few sessions on the floor, not weeks in a classroom.

A few habits make the transition easier:

• Keep the first app small and contained.

• Write down each validation step when it happens.

• Use change control for every update, even small ones.

• Keep modules separate so edits don’t ripple everywhere.

• Let operators own the feedback loop.
  
  

After the first success, scaling becomes routine. Each new SOP builds on what’s already validated, so expansion takes days instead of months.

Most pharmaceutical teams already know where paper SOPs fall short. What’s harder is finding a way to fix it without adding another layer of IT work. Tulip gives operations and quality teams a way to do that themselves.

With Tulip, SOPs become interactive applications that guide work, capture evidence, and maintain compliance automatically. They aren’t files on a screen—they’re the live version of the process itself.

Teams build them directly, using visual tools instead of code. Steps, checks, photos, approvals—everything that would normally live in a document can be embedded in the workflow. Once validated, the same system tracks version history, signatures, and data changes automatically.

When connected to MES, QMS, or ERP systems, the SOP becomes part of a complete record of production e.g. what happened, when, and by whom. Every action is time-stamped and tied to the operator who performed it, in line with ALCOA+ and 21 CFR Part 11.

A global pharmaceutical manufacturer used Tulip to digitize SOPs across three lines. After six months, procedural deviations dropped by roughly a third, and preparing for audits took half the time.

Digital SOPs built this way don’t add overhead. They reduce it. Operators spend less time searching for instructions, and quality teams get records they can rely on.

Digital SOPs are an easy way to increase operational efficiency and ease compliance in highly regulated industries. For pharmaceutical organizations looking to go further in digital manufacturing, digital SOPs provide an easy, quick way to create value, reduce risk, and build digital infrastructure.