Transforming without stopping: digitalization and traceability in pharmaceutical production

🔍 Article co-created with Víctor Marceles, Technology Director at Procaps Colombia (🇨🇴 Colombia), and Augusto Unzaga, host of Keru Podcast.

🎙️ This article was inspired by Episode 23 of Keru Podcast.

Keru Podcast, created by Globalita.io, is a series of conversations (in Spanish) with industrial leaders from Latin America about management, technology and decision-making in complex environments.

01Digitalizing without interrupting: the hidden challenge in regulated plants

Implementing technology in the pharmaceutical industry is not just a matter of budget. It is a matter of balance. Production cannot stop. Regulations cannot be breached. And new systems cannot fail. In this context, digital transformation in pharmaceutical production demands a different logic: every step forward must integrate without creating friction.

Víctor Marceles Colombia, from his role at Procaps Colombia, sums it up like this:

“Technology can’t be a layer on top of chaos. First you have to organize, understand, stabilize… and only then digitalize.”

That prior organization was the first step in the transformation process he led. Instead of rushing toward new systems, the investment went into precisely mapping every operational flow: raw materials, personnel, machinery, quality controls, documentation, downtime. Only when the real data was clear was it decided what to digitalize.

This approach is in line with the principles of Lean Digital Transformation: first eliminate waste, then stabilize processes, and only then automate what adds value.

The common temptation —digitalizing what is disorganized in the hope that it will get organized— was ruled out. As Víctor states:

“The best tool can fail if you connect it to a poorly defined process.”

That is why the first investment cycle was not in technology, but in process mapping, improvement workshops, SOP reviews and cross-training. Only once the system was stable did the integration of digital systems begin.

02Traceability in pharmaceutical processes: beyond control, a competitive advantage

Traceability in pharmaceutical processes is more than a legal requirement. Properly implemented, it becomes a decision-making tool, a layer of operational safety and an advantage over competitors. At Procaps, Víctor’s approach was clear: turn traceability into an asset.

To achieve this, he drove a comprehensive traceability strategy that brought together:

• Recording of raw materials from the moment they enter the warehouse.
• Digital links between production batches and the operators involved.
• Integration with quality laboratories to relate results to manufacturing parameters.
• A final link with dispatch and distribution, tracing the product all the way to the sales channel.

This was structured through a digitalized batch record system, combined with on-site scanning and line sensors. Every data capture point was designed to be non-intrusive, intuitive and automatic whenever possible.

This model is aligned with the principles of Good Automated Manufacturing Practices (GAMP 5) and makes it possible to comply with standards such as 21 CFR Part 11, which require integrity, traceability and security of electronic data.

“Traceability isn’t just knowing what happened. It’s being able to explain why it happened, when, and who did it.”

But beyond compliance, this traceability made it possible to anticipate. By analyzing cross-referenced data, the team detected correlations between shifts, environmental conditions and final quality. This allowed them to adjust critical variables in real time, reducing the percentage of rework and increasing process yield.

03Automating without losing control: how to scale technology with an operational vision

One of the most frequent mistakes when digitalizing plants is implementing management or control systems that only serve to show results to senior management, but do not help the operations team. For Víctor Marceles Procaps, that kind of investment is useless: digitalizing without empowering the operator is just cosmetic.

That is why the design of Procaps’ technology system prioritized operational visibility. Every new function had to be useful for whoever was on the line, not just for whoever put together the report.

“If the screen doesn’t tell you something useful at the right moment, then it’s just decoration.”

Local dashboards were implemented that showed:

• Real-time compliance indicators by batch.
• Early alerts for deviations in temperature, pressure or mixing time.
• Progress status by workstation and by assigned team.

This approach is inspired by the Andon methodology of the Toyota Production System, where the system raises an alert when something is not going as expected, allowing immediate action. The logic of Poka Yoke was also applied, designing devices or routines that prevent errors of omission.

In parallel, work was done on the data architecture. It was not about having more information, but better information. Key parameters (critical KPIs), owners by data type and consolidation times were defined. This delivered a double benefit: faster decisions and a lighter operational load for generating reports.

“We wanted the data to work for us, not the team to work for the data.”

This digital culture also involved deep changes: new profiles, intensive training and a complete review of the workflow. But the results justified it: greater equipment availability, a lower percentage of deviations and complete end-to-end traceability.

04Scaling without adding complexity: how to stay agile while growing

One of the frequent risks in digital transformation in pharmaceutical production is that, as systems, sensors, platforms and data are added, the operating environment becomes more complex instead of simpler. For Víctor Marceles Colombia, that risk can only be avoided with a clear obsession: that every digital step improves agility rather than hindering it.

“Transforming isn’t filling everything with technology. It’s freeing people to do what no machine can do.”

At Procaps Colombia, one of the key decisions was to set up a technical interoperability committee. This group did not decide whether a tool was good, but whether it could coexist with the others, whether it was scalable and whether it could be adopted without friction. This logic follows the ISA-95 model, which structures integration levels in complex industrial environments.

Thanks to this planning, it was possible to connect:

• ERP with MES (Manufacturing Execution System) systems
• Line sensors with operational control boards
• Quality systems with digitalized production records

This modular architecture avoided technical bottlenecks, reduced dependence on single suppliers and gave each area autonomy in managing its information, without losing systemic integrity.

The principle of “quick testing” before scaling was also applied. Every new technology was tested in one operational cell before being integrated into the rest of the plant. This logic, taken from the Agile applied to manufacturing approach, made it possible to iterate without risk and generate accelerated internal learning.

05Digital culture: how to build an operation that thinks in data

The hardest technology implementation is not the system itself. It is the cultural change. Installing sensors or screens is not enough if the team does not use them, does not trust them or does not know how to interpret them. For Víctor Marceles Procaps, digital success depends on people who understand why to digitalize and how to use what technology makes possible.

“A digital factory isn’t the one with the most screens. It’s the one that makes better decisions, faster and with fewer errors.”

That is why there was heavy investment in training. Not only technical, but cultural. Internal programs were created for operators and supervisors focused on three dimensions:

1. Data comprehension: what each indicator measures, why it matters, how it is calculated.
2. Real-time analysis: what to do when an alert goes off, how to read a deviation, when to escalate an incident.
3. Digital continuous improvement: how to propose adjustments to the system, how to report functional errors, how to take part in upgrades.

This approach is based on the Digital Lean model, where continuous improvement principles are integrated with digital tools as support, not as a replacement. The goal was to build technical autonomy, so that every person on the plant floor could interact with the technology without fear or dependence.

Work was also done to eliminate the culture of punishing errors. Every digital deviation was analyzed as an opportunity to improve the system, not as an individual failure. This logic, inspired by the Japanese cultural kaizen approach, generated more participation, more improvement proposals and greater team involvement in the technological evolution.

“Digitalizing without culture is like buying a motorcycle and leaving it parked because nobody knows how to ride it.”

06Digital sustainability: avoiding obsolescence and planning the evolution

An often ignored aspect of digital transformation in pharmaceutical production is its sustainability. That is, what happens to those systems in 3 or 5 years. Do they still work? Do they still add value? Or do they become obsolete, disconnected or outdated? For Víctor Marceles Colombia, digital sustainability is part of the design from day one.

“We’re not installing technology. We’re building a different way of operating. And that has to last.”

To that end, three structural principles were established:

1. Planned digital maintenance: every system has its update roadmap, with planned dates and defined owners.
2. Internal support capabilities: a digital support team was developed within the plant, able to resolve basic failures, adapt configurations and take part in improvement decisions.
3. Annual strategic review: every year it is assessed whether the installed technology is still aligned with business goals, and priorities are adjusted.

In addition, clear rules were defined for data ownership, information security and access policies. These practices, aligned with GxP standards and data integrity guidelines in regulated environments, ensure that what has been built not only works, but is auditable, scalable and reliable.

Sustainability was also measured in operational results: less paper, fewer transcription errors, less variability between shifts, a reduction in batch release time and greater responsiveness to audits.

“The best indicator that a plant is digital isn’t the technology. It’s the operational peace of mind you feel when everything flows.”

🔁 Keru is a podcast created by Globalita.io, where we talk with those who lead Latin American industry from the inside.