Electronic Batch Records: How Manufacturers Are Digitizing Their Compliance Procedures

Life sciences manufacturers have long relied on batch manufacturing processes for the production of drugs, therapeutics, and medicines. This methodology is often preferable as it enables strict quality control and can easily be modified or adjusted depending on the manufacturers’ needs.

Due to the strict regulations and quality control measures that pharmaceutical and biotech producers must adhere to, batch records (also known as Batch Manufacturing Records or Batch Production Records) have long been a critical tool used to ensure the quality and safety of the products being produced.

In this post, we’ll review the basics of batch records, how they’re used by manufacturers, and how modern-day pharma and biotech manufacturers are digitizing their batch records to improve their traceability processes.

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Simply put, Batch Manufacturing Records are a form of documentation that tracks the dates, ingredients (including weights and measurements), equipment, and personnel, as well as relevant inspections, and controlled results involved in the production of a specific batch of products.

This information is critical to ensuring that proper protocols have been followed in accordance with Good Manufacturing Processes (GMP), the industry standard for regulated manufacturing. According to the FDA’s Code of Federal Regulations, “Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”

As one can imagine, the documentation and control of all these variables can become complex, time-consuming, and can easily become a source of liability for life sciences manufacturers reliant on their workforce to track each step of production from start to finish. As a result, we’re seeing more and more businesses operating in regulated environments turn to modern, digital solutions such as Electronic Batch Records to help streamline these processes, reducing the administrative burden associated with common compliance procedures.

Electronic Batch Records are tools that digitally track all of the elements associated with a batch manufacturing process. In the past several years, more and more manufacturers are turning to eBRs to compile and track batch production data. This approach helps to streamline compliance procedures, improve operational efficiency, and reduce human error in the production of pharmaceuticals.

Electronic batch records are basically the digital version of the binders everyone used to lug around. They track production from start to finish, but without the piles of paper or the endless signatures. Each operator follows a guided process on-screen. The system logs what happens and when, without anyone having to think about recordkeeping while the work’s going on.

1. Capture
Operators type in numbers, scan barcodes, or pull readings straight from connected equipment. Every action is time-stamped and linked to the person who did it. You don’t end up guessing who weighed a material or when a step was done. The record grows as the batch runs, no backfilling later, no handwriting to decipher.

2. Validation
The system checks each entry right away. If something’s missing or a reading looks off, it stops the process until it’s fixed. Different products can have different paths, so the workflow adjusts automatically. It’s not about adding control for the sake of it, it’s about catching small problems before they turn into batch deviations.

3. Approval
Once everything’s complete, the record moves to whoever signs off i.e. QA, the supervisor, or compliance. They can see every action in order, with digital signatures and timestamps already in place. Nothing to collate, nothing to clean up before an audit. What’s in the system is the record.

As discussed above, pharmaceutical manufacturers rely on their ability to track every step of the batch manufacturing process in order to uphold Current Good Manufacturing Processes (cGMP) best practices. Naturally, as manufacturers in regulated industries continue to adopt Industry 4.0 technologies, we are left answering the question—what value can digital batch records provide life sciences manufacturers? In short, electronic batch records enable businesses to:

• Reduce the resources and human error associated with documentation processes

• Streamline compliance activities

• Ensure conformity with standardized process controls

• Improve visibility of manufacturing processes from start to finish

• Increase throughput and improve production quality

With all of the benefits associated with digitization, let’s dive into some of the common questions that we receive from manufacturers looking to implement electronic batch records in their facilities.

One of the most common questions we receive when working with life sciences manufacturers is; how quickly can we really begin to see value, and when we do find value, what is the total cost of ownership over a 3-5 year time horizon? Some of the common concerns we hear include:

• Time commitment and monetary investment

• How will the implementation process impact productivity in the short term?

• Will we become reliant on vendors? What is the process for updating our system over time?

With Tulip, we’re able to address many of the common concerns surrounding time-to-value and total cost of ownership with our Software-as-a-Service (SaaS) business model. The benefit of this model is that digitization is not a capital-intensive process that requires a significant up-front investment, but rather a “pay-as-you-go” system in which the discussion around total cost of ownership becomes less of a factor than many other solutions that require a significant up-front investment.

An additional consideration that comes with the total cost of ownership discussion is the cost to upgrade and validate the system once it’s been implemented. Again, as a SaaS product, we’re able to continually upgrade our platform through an LTS release every six months. Further, the no-code nature of Tulip’s solution enables more efficient validation on an app-by-app basis.

Data Integrity

In addition to the questions surrounding the cost of digitizing batch records, we often receive many questions related to data integrity. As more and more businesses across all industries transition from on-premise to cloud-based networks, one could reasonably assume that there would be concerns about data security and accessibility.

The reality is that the world is moving towards the cloud, and the notion of managing data centers is becoming less and less sustainable, particularly from a financial standpoint. Cloud providers such as Microsoft Azure and AWS have proven to be more secure and more trustworthy than any traditional data center that exists on-prem.

Tulip has made sure that our platform is fully compliant with Electronic Records and Signatures regulatory requirements (ERES), as well as ALCOA, the industry's best practice for data integrity. Today, we have multiple customers that have validated Tulip within their environment to manage GMP data in either a virtual private cloud or our multi-tenant cloud.

Validation

Validation is one of the most important topics when it comes to the implementation of systems for life sciences manufacturers. While the FDA is releasing new guidance on how to validate digital systems in order to ease traditional validation processes, Tulip aims to take a much more practical approach when it comes to system validation.

Tulip’s platform has undergone several audits and is validated in multiple FDA-regulated environments for commercial production. When it comes to the apps that are built in the Tulip ecosystem, the conversation becomes slightly more nuanced.

Instead of thinking of apps as individual pieces of software, we find it helpful to think of them as content. For example, if you have a word document or SOP that exists in your document management system, you wouldn’t need to validate the document itself each time you make an incremental change. Instead, the document goes through a review and approval cycle, at which point it can be published and used on the floor.

Apps built in Tulip can be used in the exact same way—Whenever you build or edit an app, you can easily test it, release it through a life cycle process, and then push it to the floor to be used in production.

In regulated manufacturing, compliance is the base layer of how the work gets done. Electronic batch records are built with that in mind, they’re designed to satisfy FDA 21 CFR Part 11 and GMP expectations as part of daily operation, not as a bolt-on feature.

FDA 21 CFR Part 11: Electronic Records and Signatures
Part 11 defines what makes an electronic record or signature legally valid. For an EBR to comply, it needs to handle data and approvals in a way that mirrors, and often improves on, paper controls. That means:

• Each record carries a secure, time-stamped audit trail.

• System access is tied to unique user accounts and specific roles.

• Every signature links to a real person, the action they took, and the exact time it happened.

• Approved records can’t be changed or overwritten.
  
  

In a compliant system, these controls run quietly in the background. Operators don’t have to think about compliance steps while they work; the software enforces them automatically.

GMP: Accuracy, Traceability, and Control
GMP focuses on consistency like doing the same work, the same way, every time, and being able to prove it. EBRs help by guiding operators through validated procedures that are version-controlled and locked against unapproved edits. Data is captured directly as the work happens, not copied later, which removes a common source of transcription errors.

Each batch record shows exactly which materials were used, who performed each step, and when. Quality teams don’t have to dig through binders or read unclear handwriting during an inspection; the record is already complete, searchable, and easy to review.

Audit Trails
Every action in the system i.e. data entry, signature, edit, or approval, is logged automatically. Those logs can’t be altered, giving you a full trace of what happened and when. It’s the kind of documentation inspectors expect to see: continuous, verified, and impossible to backfill.

Compliance isn’t something added at the end.

EBR vs. Paper vs. MES

When it comes to recording and approving batches in regulated manufacturing, most plants sit somewhere between three systems: paper binders, a full manufacturing execution system (MES), or a purpose-built electronic batch record (EBR) platform.
Each option works, but they behave very differently once production starts moving.

What That Means on the Floor

Paper gets you moving fast but costs time later, especially when errors show up during review.
MES platforms are powerful, yet they often move slower than production needs and can be tough to adapt once validated.
An EBR system sits in the middle: structured enough for compliance, flexible enough for everyday change, and light enough that QA and production can manage it without constant IT help.

Tulip approaches electronic batch records from the ground up. Instead of wrapping production in a complex MES, it gives operations teams a practical, no-code way to build what they need. The system fits around how work actually happens, not the other way around.

Built for Agility, Not Complexity
With Tulip, engineers and process owners can create and adjust batch record apps directly. The tools are visual, just drag, drop, configure and no programming is required. You can define approval paths, capture data points, and enforce GMP steps in the same workspace.
Projects that would normally take months to develop can move in weeks. And because the workflows are modular, you can keep tuning them as processes change instead of waiting for a new release cycle.

Real-Time Data on the Floor
Tulip collects data where the work happens. Operators enter values, scan materials, or confirm steps right in the app. Machines and sensors feed data automatically. Every entry carries a timestamp and user ID, so the record builds itself as the batch runs.
The system checks inputs as they come in, catching out-of-range readings or skipped steps immediately. By the time a batch finishes, the record is complete and locked for review.

Works with What You Already Have
Tulip doesn’t ask you to replace existing systems. It connects to them.
Apps can pull data from your ERP for batch details, send release results back, log deviations into your QMS, or read directly from line sensors and devices. The open APIs make those links straightforward, which keeps your current infrastructure intact while adding real-time traceability.

Compliance Built into the Workflow
Every Tulip app supports electronic signatures, role-based permissions, and version-controlled procedures that meet 21 CFR Part 11 expectations. The controls aren’t extra layers, they’re part of how each step runs.
That means QA and IT don’t have to bolt on compliance checks later; it’s handled within the workflow itself.

A Practical Path to Digital Batch Records
Teams adopting Tulip usually start small, a single batch process or one line, then expand once they see how it fits. The pace is set by the plant, not by software constraints. You get traceability, control, and speed without the drag of a traditional MES rollout.

Summary

As we’ve outlined in this post, it’s clear that the future of life sciences manufacturing is shifting toward digital solutions to address some of the greatest challenges surrounding the production of regulated goods. With solutions like Tulip, manufacturers are more easily able to make data collection and validation a continuous, seamless part of their production process.

As businesses integrate apps into their work environment, data across every procedure is automatically collected from operators and machines, making electronic batch records an easy and efficient way to demonstrate compliance. As a result, manufacturers can begin spending more time ensuring the quality of a product and less time correcting errors in their compliance records.

Manufacturers who take the necessary steps to embrace a digital future now stand to benefit from seamless compliance, but it need not stop there. By adopting a more complete digital transformation strategy, businesses are able to increase connectivity, improve efficiency, and gain a major competitive edge in their industry.

If you're interested in learning more about how you can digitize your batch records and streamline your compliance efforts, reach out to a member of our team today!