Since the introduction of formal GMP regulations in the 60's and 70's, the batch record has been a cornerstone of how pharmaceutical manufacturing operates. David Margetts, group executive director of Factorytalk and BatchLine discusses.
Factorytalk
Batch records document what happened, support record keeping compliance, and provide traceability and audit evidence when needed. But beyond that, they have often been overlooked as something that actively contributes to manufacturing performance and product quality.
That view is starting to change across the industry and the world.
The batch record is no longer just a record
In many organisations today, the expectations around manufacturing have shifted.
It is no longer enough to document processes after the fact. People need visibility during production, for faster decision-making, and to ensure that formal processes are being followed correctly in real time.
This is where the Electronic Batch Record (EBR) is changing the role of the production records.
Instead of being something that is reviewed at the end, with less dependency on the running process, it becomes part of how the operation is executed- by guiding operators, capturing data from people and machines as it happens, and to make all information available when it is needed.
In that sense, the batch record starts to move from a purely documentation exercise, towards driving operational improvement and intelligence.
The legacy and limitations of paper are now clear
Paper-based batch records are widely used in both large global pharma companies and smaller regional players, and yes they do and can meet compliance requirements. But as the regulations are evolving through data integrity initiatives, and a push for continuous assurance, they introduce gaps, risks and challenges that many production and quality teams are already familiar with and struggling with every day.
Information on paper is not easy to access, or to utilise for analytics. Reviews take far too long, due to time and effort to collect and check large amounts of physical documentation. Errors are often only discovered late in the process, these can be mistakes in documentation, or actual process deviations and non-conformances that impact product quality. And when something needs to be investigated, it takes significant effort to piece everything together, usually too late to resolve issues in the ongoing production leading to scrap, or at best rework.
At the same time, manufacturing itself is becoming more complex and dynamic. Products are more varied, global markets and supply chains make timelines and compliance tighter, and expectations around data integrity and use of data for continuous improvement is to increasing.
Paper was not designed for this environment, and that gap is now clear for both industry and regulators. This is reflected in shifting industry trends. According to Markets and Markets, investments in manufacturing digitalisation is expected to grow from $3.4 billion in 2025 to over $5.5 billion by 2030, while broader smart manufacturing activity is set to more than double in the coming decade—highlighting how quickly manufacturing companies are moving toward digital, data-driven operations.
Digital is not just about replacing paper
One of the common misunderstandings is that moving to digital simply means recreating paper forms on a screen.
In practice, that approach can provide value, however from a process improvement perspective it does not change much.
The real difference comes when EBR systems are used to structure and guide how work is done more efficiently and with more control. Steps are followed in sequence, right first-time checks are built into the process, and data is captured and calculated automatically rather than written down by hand and re-entered and re-checked later.
This changes the role of the batch record significantly. It becomes something that supports execution, provides highly contextual and high-quality data for analysis, and thus is not just a documentation.
We need more practical approaches to digitalisation
There has also been a change in how companies approach digital projects.
Large, complex programmes are no longer the default starting point. Many organisations are taking a more focused approach—starting with a specific process or product, seeing the results, and then expanding from there.
David Margetts, group executive director at BatchLine, said: “Digitalising batch execution is vitally important, and must be accessible for all GxP manufactures without requiring years of complex MES projects. The focus should be on solving real operational problems in a practical and incremental way, and delivering value early, building momentum and without adding unnecessary efforts and costs.”
This reflects what many teams are already experiencing—that progress tends to come from small, well-defined steps rather than large transformations.
Data is becoming more than a compliance requirement
Another noticeable shift is how batch data is being used.
Traditionally, it has been something that is stored and reviewed when required. Now, there is significant interest and ability to use that data more actively—whether for monitoring performance, identifying issues earlier, or improving operations over time.
That is only possible when the data is captured in a structured and accessible way.
Without that, even the most advanced tools will struggle to provide meaningful insights.
This growing importance of data is also reflected in how pharmaceutical companies are increasingly relying on digital approaches to collecting and utilising information for business improvement. Around 84% of organisations now use cloud platforms for data management, and 70% of leading pharma companies leverage advanced analytics to process large-scale datasets (Gitnux). A gradual but seismic shift, not sudden change
It is important to recognise that this is not an overnight transition, and that introducing any change in regulated manufacturing facilities has to be done with care, and to not disrupt the existing production people, volumes and product quality.
Most organisations move through a mix of paper and digital processes for some time. That can create its own challenges, but it is often part of the journey.
What matters is having a clear direction and making steady progress.
Looking ahead
There is a lot of discussion around AI, advanced analytics, and connected manufacturing. These are all important developments, but they depend on having the right foundation in place.
The digital electronic batch record sits at the centre of that as a data foundation.