If you manage your batch records using a manual process, you know how time-consuming and challenging it can be. Electronic batch records systems are designed to make it easier to manage batch records, ensuring your products are of the highest quality and are compliant with regulations.
We tackled the topic of electronic batch records in a recent webinar, and now we’re sharing the key takeaways with you here. So, let’s get started.
What is a Batch Record?
Ken Lownie, CMO of Scigeniq, kicked things off, explaining what batch records are and why they are important.
A pharmaceutical batch record, also known as a batch production record, is a comprehensive document that provides a detailed record of the manufacturing process and includes controls for a specific pharmaceutical product batch. It provides the instructions for a batch and the record of the actual production that happened for that batch. A batch record is a critical document in the pharmaceutical industry to ensure product quality, consistency, and compliance with regulatory requirements.
Here’s an example of a batch record for cough syrup.
“This is a hand-written batch record. If you are a chemist or a pharmacist, or a medical person, you can see that this was for cough syrup. I see simple syrup; I see wild cherry flavor. So, these are the instructions for making cough syrup in a particular factory. And then some records about what was actually done. If you look to the right, it says weighed by, checked by with two sets of initials. So, a very simple batch record handwritten from another time.”
Here’s a more modern batch record. It looks simple, but if you look at the top right, it says page 1 of 16.
Now let’s look at an electronic batch record.
Here’s an example front page of the EBR electronic batch record, which is computer-controlled and going through the system.
There are typically five things you’ll find in a batch record:
- What batch are we referring to, like a batch number and other identifiers?
- What raw materials are we talking about?
- What are the work instructions or procedures for building this particular product or mixing this product?
- The equipment used and the equipment records at that time?
- And then quality inspection records are sign-offs of did this happen and who checked the work?
Five Key Capabilities of an EBR
Abdullah Othman, chief product officer for Scigeniq, shared the five key capabilities of an electronic batch record system. These include:
No-code configuration and user-friendly setup:
Modern EBRs should have a no-code configuration and be user-friendly, enabling easy configuration of fields and integration with other systems. Also, portable devices such as tablets can be used for easier access and interaction with EBR systems on the production floor.
Cloud-based, flexible, and scalable:
Cloud-based EBR solutions offer flexibility and scalability, allowing for easier integration with quality management systems and lab equipment. “If you have the EBR software configured for one product, you can easily scale it up to another product or SKU, another batch size, another production line, or even if you have different sites.” A modular EBR also enables you to integrate other systems, like your QMS or LIMS, giving you one place to see everything and richer analytics and dashboards.
A modern EBR does not just capture the data about the batch; it guides the process through each step with a workflow capability that updates the record at each step and launches the next step.
A fully validated system with updates:
A cloud-based solution means it comes pre-validated, including for CFR Part 11, Annex 11, and GAMP five features such as e-signatures, audit trails, and permissions. These all come out of the box, along with free updates.
Cost Effective and Fast to Set up:
This last point is accumulative of what we discussed. If you think of traditional solutions, they are not cost-effective. You want a cost-effective solution that is fast to implement. The following table describes it best.
Three Key Takeaways on EBRs
Ken and Abdullah offered a lot of information on electronic batch records, too much to share here. We’ll leave you with three key highlights from the session.
Takeaway 1: Electronic Batch Records can serve as a crucial link connecting the manufacturing and quality ecosystem, streamlining processes, and ensuring product consistency and compliance.
Ken highlighted the importance of electronic Batch Records (EBRs), and Abdullah added that modern EBRs should be user-friendly, easily configurable, and able to integrate with other quality management and manufacturing systems.
Abdullah also noted that cloud-based EBR solutions offer more flexibility and scalability, allowing companies to quickly adapt to new product lines, batch sizes, or production sites. He emphasized the importance of having real-time dashboards and analytics to monitor production processes efficiently and how modern EBRs can provide more effective integration with other quality management systems for better overall control.
Takeaway 2: Implementing an Electronic Batch Record system should start with a well-scoped, carefully planned approach, focusing on user adoption and incremental expansion.
Abdullah advised on implementing Electronic Batch Record systems, suggesting that companies should “pick an easy battle first” and start with a limited domain that can have a definitive impact quickly. He also recommended appointing a product owner who has the subject matter expertise to manage the implementation project and communicate effectively with users and the implementation team.
Furthermore, he emphasized the importance of expanding the EBR system incrementally, focusing on small wins and consistent integration with existing processes. Abdullah also stressed the need to promote the EBR system internally, using real examples and case studies to showcase the benefits and drive user adoption.
Takeaway 3: Modern Electronic Batch Record systems can significantly reduce the time and effort required for quality control processes, increasing efficiency and cost savings.
Discussing the benefits of modern EBR systems, Abdullah highlighted the potential for reduced time and effort in quality control processes and the ability to produce more products faster with fewer resources. He explained that EBR systems can provide real-time data, allowing for efficient monitoring and control of manufacturing processes, reducing deviations, and improving overall quality.
Abdullah also pointed out how cloud-based EBR solutions can be more cost-effective for companies, with faster implementation times and lower upfront costs than traditional on-premise systems. He concluded by emphasizing the importance of seamless integration between EBR systems and other manufacturing and quality management systems, enabling companies to achieve greater control and efficiency in their production processes.
Implementing EBR in Your Company?
Are you thinking of implementing an electronic batch records system in your company? EBR systems are no longer just for enterprise companies. Modern EBR systems are also designed to support small and mid-sized pharma companies because they are easier to set up and use.
You can watch the webinar on-demand to see Scigeniq’s EBR solution and learn how it integrates with Scigeniq QMS to give you a more complete view of your production processes. Or you can request a demo and dive deeper into how an EBR can work for your specific requirements.