What is an electronic batch record?

    According to a report from the Food and Drug Administration (FDA), more than 400 organizations receive a letter for not complying with standard operating procedures (SOPs) and having problems with record keeping. Traditionally, paper-based batch records are used to record the entire history and manufacturing process of a product batch. This includes how a product is manufactured and describes the who-when-where of different processes and how they are executed.

    However, doing things with paper in this digital age comes with plenty of drawbacks. That’s why pharmaceutical industry players are rapidly adopting software solutions that can add value to their business processes. Electronic batch records (EBRs) are one of those solutions helping life science companies minimize human error, boost operational efficiency, and streamline compliance procedures.

    The issue with paper batch records

    Many life science companies create batch records manually. Their employees perform all steps of the batch process on paper—filling out records, recording reviews, and conducting record audits. These processes can be cumbersome, slow, and prone to human error. This can impact an organization’s ability to pass audits by a regulatory body and get their medical devices out to the public.

    A batch record can comprise of thousands of pages entailing thousands of fields for a single production process. Management has to ensure that the correct employee fills out these fields at the right time within the predefined range of values for a manufacturing process. However, the manual approach of entering values can lead to errors, including:

    • Scribal errors. The employee responsible for completing the batch record form may enter an illegible value, which can make it unreadable to others. As a consequence, corrective action is required to fix it.
    • Missing values. Since there’s no mechanism to enforce entering a required value in a form, an employee may accidentally miss writing a value. During validation and review of batch records, this can lead to a time-costly correction process.
    • Illegal values. An employee might add values that don’t conform to the acceptable range of values. This value has to be crossed out, and the right value must be added to the form, which entails more time lost in corrections.

    What is an electronic batch record?

    An electronic batch record is a system that substitutes the use of paper by digitizing batch records, enabling paperless manufacturing. It collects information from multiple databases that store the data of a batch’s manufacturing process. And EBR also uses a business process engine to define how a process should be performed. The instructions and tasks in an EBR are recorded in a user interface, which guides operators (e.g., an engineer). This way, they can record applicable results and monitor activities.

    An EBR offers manufacturing context to all tasks that a production process needs to execute. When it comes to resources, it specifies who has to execute a task. For equipment or assets, it defines where a task needs to be executed.

    By integrating an EBR system with devices and instruments, you can automate the collection of data coming from production processes, eliminating the need to write it on paper. Operators in the lab interact with different devices and instruments that generate process data, such as sensor data and QC readouts. An EBR system can be integrated with these systems to automate data capture, minimizing the risk of error.

    Benefits of electronic batch records

    Electronic batch records can save resources, especially time spent on mundane tasks, and boost efficiency by automating the management of batch records.

    Improve consistency and accuracy

    Humans are prone to bad days, attention lapses, and sleep deprivation that can affect what they write on paper. An electronic batch record system reviews user input in real time and detects errors, which can minimize the possibility of wrongly collected or incomplete data.

    Boost productivity

    An EBR system removes error-prone and time-consuming data entry, allowing you to redirect human resources to other areas where creative decision-making can be useful. For example, employees can use the saved time to work on developing and maintaining SOPs.

    Save resources with review by exception

    One of the features that an EBR system supports is review by exception functionality—an approach that cuts redundant review time. It highlights elements in the record that don’t comply with the specification. As a result, a batch record specialist or any other worker reviewing the record has to review only the highlighted items, saving the crucial time that otherwise would have been spent finding errors.

    Standardize processes

    You can use an EBR system to distribute the same batch records to all operators. This verifies that all operators are working on the same version, even if they are based in different facilities. The standardization of workflow can reduce the risks of errors that occur due to operators working with outdated data.

    Make data-driven decisions

    Paper-based records store data in a difficult-to-access and disconnected manner. If someone from management wants to use this data to make a decision, it can take a lot of time to convert this data into a usable format. Due to these reasons, companies might decide to make decisions without using data, which can lead to less optimal decisions. For example, how many batches were produced in the past week? Where were the deviations? How were the yields? An EBR system can provide answers to these questions.

    An EBR system is user-friendly, allowing users to navigate through and find the right data within minutes. They can also turn this data into a table, view it in a dashboard for monitoring, or print it as a PDF. This way, it can promote data-driven decision-making.

    Automate your document management

    Are you still using paper batch records? Now is a good time to take a step toward paperless manufacturing and digitize your batch records. In fact, you can consider automation for all types of documents. Why should your employees continuously chase their supervisors for signatures when it can be done with a few clicks via electronic signatures? For this purpose, you can employ an electronic quality management system like Qualio.

    With Qualio, you get an integrated digital repository that can track your complete documentation stack. A single click is all you need to generate release documentation. It also provides an in-system web editor to collaborate on files, streamlining your document management.

    Book a demo and see for yourself how Qualio can save your time and money with next-level document management.