Best Electronic Batch Record (EBR) Software in 2024

Electronic Batch Record (EBR) software is a digital platform that tracks, monitors and reports on batch production in real time throughout the manufacturing process. EBRs are particularly important for pharmaceutical companies, giving them an efficient means of tracking and managing quality, as well as satisfying regulatory requirements.

Master Batch Record software is a digital platform that outlines how to accurately manufacture a specific drug or device. A Master Batch Record (MBR) is the overarching set of records that contains all formulas, instructions and manufacturing processes used to make a specific product. Its intent is to ensure that the correct ingredients and processes are used in the right sequence each time a product is manufactured, so that the product always has the same properties and characteristics.

A batch record (BR), and by extension an EBR, is a batch-specific version of a Master Batch Record. MBRs and EBRs are part of Good Manufacturing Practices (GMPs) and are required by international and national regulatory bodies, such as the U.S. Food and Drug Administration (FDA), to track and trace a pharmaceutical product’s inputs in the event the product’s quality is called into question.

Pharmaceutical and Life Sciences companies striving to reduce costs and boost production while maintaining quality will find that EBR software offers an efficient solution that delivers a strong return on investment (ROI). Some specific benefits of EBR software include:

Operational efficiencies

Using an integrated digital solution for maintaining batch records offers many operational efficiencies, including:

• Automated data entry, document revisions and record retrieval

• Quicker identification of deviations and nonconformances

• Single data source and real-time data

• Standardized procedures and workflows

• Built-in compliance, including time-stamped audit trail and end-to-end traceability

• Fewer approval bottlenecks and production delays

• Electronic alerts and reminders

• Less risk of wasted time and resources

Greater accuracy

EBR software streamlines batch record management, from laboratory controls to packaging and labeling. EBR software eliminates potentially costly manual errors and improves data integrity. It can flag inconsistencies, providing easy integration with data and enabling greater insight into production. Improving accuracy supports compliance and can lead to reduced production times and, ultimately, faster time to market.

Improved regulatory compliance

EBR software simplifies regulatory compliance efforts with a batch record framework that automates every step of the process. Data collection is streamlined and can be linked with device master records, inspection reports and other related documentation. Electronic records are better protected than their paper counterparts and more easily retrieved for regulatory audits and filings. This not only saves time and resources, but also mitigates the risk of penalties for non-compliance.

Informed decision-making

EBR software unlocks the power of real-time data. By capturing and aggregating production data electronically, EBR software can offer valuable insights. Organizations can identify areas of inefficiency, pinpoint bottlenecks, and track trends to optimize production. This data-driven approach allows you to make informed decisions that minimize waste and maximize output, ultimately boosting your bottom line.

The core features of EBR software encompass a suite of functionalities designed to streamline and enhance batch manufacturing operations while ensuring compliance with regulatory standards. Below are some of the key features of EBR software:

Electronic document control

EBR software digitizes the entire batch record process, replacing traditional paper-based documentation with electronic records. This includes batch records, SOPs, material specifications and other relevant documents. Electronic documentation ensures data integrity, version control and accessibility, facilitating easier retrieval and review during audits and inspections.

Automated audit trail

EBR software generates comprehensive audit trails to track all activities and changes throughout the batch lifecycle. This includes user actions, system events and data modifications, providing a complete history of batch execution and documentation. Audit trail functionality enhances traceability and transparency, enabling thorough investigation of deviations and facilitating regulatory compliance.

Inventory tracking and control

By integrating with inventory management systems, EBR software provides lot traceability to each material used in a batch. Real-time visibility into raw materials and product inventory levels can be monitored throughout the production process. This enables accurate forecasting, procurement planning and as-needed inventory management, minimizing stockouts and excess inventory, as well as associated costs.

Inspection management

By centralizing inspection processes and digitizing documentation, EBR software enhances inspection efficiency, accuracy and compliance, ultimately contributing to product quality and regulatory adherence.

Real-time analytics

EBR software offers robust reporting and analytics capabilities to analyze batch data and performance metrics. Users are able to generate customizable reports, dashboards and KPIs to better gauge operations and gain insights into batch quality, production efficiency and compliance status.

Automated alerts

EBR software incorporates automated alerting mechanisms to notify users of critical events, deviations or compliance issues in real time. Alerts can be configured based on predefined thresholds, rules or user-defined triggers, ensuring timely intervention and corrective actions. Automated notifications help mitigate risks, reduce downtime and prevent quality issues before they escalate.

How does EBR software help with regulatory compliance?

One of the major benefits of EBR software is its boost to regulatory compliance efforts through integrated data, standardized record-keeping and simplified traceability. The Food and Drug Administration (FDA) and GMP put forth regulations requiring that each step of an EBR be completed. EBR-related software regulations include:

FDA 21 CFR Part 211: Also known as cGMP, this is the primary standard outlining the steps for meeting minimum good manufacturing practice (GMP) standards for finished pharmaceuticals in the United States. Although meeting these standards can be a complex endeavor, the major elements involve:

• Qualifications and skills of personnel
• Equipment and facilities maintenance
• Control of components, product containers and closures
• Production and process controls
• Packaging and labeling controls
• Warehousing and distribution
• Laboratory controls
• Records and reports
• Returned and salvaged drug handling procedures

21 CFR Part 210 is used in conjunction with Part 211. Where Part 211 focuses on process control for finished pharmaceuticals, Part 210 outlines minimum standards for manufacturing, facilities and controls. Electronic batch records must also be fully 21 CFR Part 11-compliant, with electronic signatures and full-data integrity and retention.

EBR software allows you to centralize your documents in a cloud-based solution for easy access and revision. Planning, production and quality applications are integrated. So sharing and capturing data from applications, such as inspections and nonconforming products, is accomplished with greater precision. The risk of manual recording errors, such as incomplete dates or transposed numbers, is virtually eliminated. Data and records are automatically updated and easily located for regulatory filings and audits.

Batch records are the foundation of quality control in pharmaceutical manufacturing. Just like most industries, the ability to take full advantage of automation can give a manufacturer a competitive edge. In the highly regulated pharma industry, that edge must fall within strict regulatory guidelines. When done correctly, EBR software can help pharma manufacturers reduce costs by reducing the time spent on batch record preparation and maintenance.

What’s more, EBR software speeds up time to market by providing:

• Earlier detection of nonconformances
• Better data accuracy
• Reduced investigation times
• Quicker data capture and sharing
• Improved inventory management
• Easier traceability and trackability

Due to the complexity of the data controlled, the option to move to EBR software can seem overwhelming. But implementing EBR software is a strategic investment that delivers tangible ROI, especially if you choose a solution like QT9, which offers an out-of-the-box, fully-validated platform, user-friendly interface and responsive implementation team.

Every pharma manufacturer will have its own implementation challenges. Additional strategies to consider when implementing EBR software:

• Look for an out-of-the box solution, which can reduce costs and implementation times. OTTB EBR software can also be less overwhelming, since modules are all built with similar interfaces.
• Ensure your EBR software solution is scalable, allowing you to prioritize module implementation and proceed at your own pace.
• Ensure the appropriate training and communication for employees transitioning to the new software. Some resistance to change is common but can usually be addressed through the reassurance of consistent training and open communication.

From streamlined workflows and improved product quality to enhanced efficiency and regulatory compliance, EBR software empowers manufacturers to operate smarter, not harder.