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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What is a Batch Manufacturing Record (BMR)?
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.
What are Electronic Batch Records (eBR)?
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.
Tracking, tracing, & genealogy—How to get started with digital transformation in life sciences
As discussed above, pharmaceutical manufacturers rely on their ability to track every step of the batch manufacturing process in order to uphold Current Good Manuring 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.
What does Time-to-Value & Total Cost of Ownership look like with electronic batch records?
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.
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 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 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 around 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.
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!
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