Best Electronic Batch Record (EBR)
Software in 2024
April 30, 2024
Pharmaceutical manufacturing requires precision, consistency and vigilance toward safety and compliance. Batch records are the backbone of these goals. And electronic batch record (EBR) software is the digital cornerstone transforming traditional batch record management. EBR software seamlessly automates batch record creation and maintenance, ensuring adherence to stringent regulatory standards and enhancing operational efficiency.
Through digitization, EBR software meticulously oversees each step of the production journey, guaranteeing that ingredients, procedures and sequences align to maintain product integrity. This article is your guide to EBR software and its role in quality and compliance, offering seamless traceability and accountability across the manufacturing continuum.
What is EBR software?
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.
What is Master Batch Record (MBR) software?
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.
What are the benefits of EBR software?
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:
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Automated data entry, document revisions and record retrieval
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Quicker identification of deviations and nonconformances
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Single data source and real-time data
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Standardized procedures and workflows
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Built-in compliance, including time-stamped audit trail and end-to-end traceability
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Fewer approval bottlenecks and production delays
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Electronic alerts and reminders
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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.
Core features of EBR software
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.
Importance of EBR software in pharmaceutical manufacturing
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
Implementing EBR software
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.
QT9 QMS
QT9 QMS is consistently one of the top-rated quality management systems available. It is versatile for companies big and small with truly unlimited scalability. This easy-to-use platform centralizes and automates quality processes for the most highly regulated industries, including medical device manufacturers, life science companies and aerospace companies. It is a great all-around option for companies with over 25 modules included for better data centralization and analytics.
It’s not just us. QT9 QMS is loved by customers and auditors alike.
Rated 4.8/5 on G2
Rated 4.7/5 on Capterra
Pros:
- Over 25 modules included
- Cloud-based platform, with on-site availability
- Out-of-the-box with configuration capabilities
- Unlimited customer support
- Easy-to-use interface
- Unlimited data storage
- Fully validated
- Concurrent-license pricing structure
- ERP integration
- Supplier, customer and employee portals for easier traceability
- Free trial available
Cons:
- Limited customization
- Limited workflows
Core Modules
25 Included
Support & Training
Unlimited
Validation
Included
Free Trial
Yes
MasterControl
MasterControl is used by some of the largest Pharma and Med Dev companies and has a versatile platform that offers advanced customization. The integration between modules enables large, enterprise-scale companies to adapt to a digital platform with ease. With a focus on companies in the life sciences, MasterControl is able to connect many aspects of quality management.
Rated 4.3/5 on G2
Rated 4.5/5 on Capterra
Pros:
- 12 core applications
- Cloud-based platform
- Highly customizable
- Pre-built integrations available
- Configurable workflows
- Robust customer support
- Supplier Portal available at extra cost
- Validation available at extra cost
Cons:
- Higher costs as applications are added
- Mixed reviews about ease of use
- No customer portal
- No ERP integration
- No free trial
Core Modules
12 Included
Support & Training
Optional
Validation
Optional
Free Trial
No
Greenlight Guru
Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more.
Rated 4.5/5 on G2
Rated 4.5/5 on Capterra
Pros:
- 6 core modules
- Out-of-the-box or customized functionality
- Integrated product-design controls and data capture
- Document control with in-system editing available
- Fully validated
- Simple user interface
Cons:
- MedTech focus limits applications
- Reduced configuration capabilities
- Fewer modules hinder scalability
- No supplier integration
Core Modules
6 Included
Support & Training
Optional
Validation
Optional
Free Trial
No
Qualio
Qualio is a cloud-based quality management software system designed for life science companies. Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to the market faster, boost revenue and cut risk. Companies use Qualio to embed and automate GxP, FDA and ISO compliance.
Rated 4.4/5 on G2
Rated 4.6/5 on Capterra
Pros:
- 8 core modules
- API integration with Salesforce
- Document control with in-system editing capability
- Configurable workflows
- Consistently high rankings for ease of use
- Fully validated
- 24/7 customer support
Cons:
- Fewer modules hinder scalability and data centralization
- Extra capabilities are an added expense
- No dedicated calibration/maintenance function
- Licenses required on per-user basis, including for read-only access
- Reported difficulty linking quality event data
- No supplier portal
- No free trial
Core Modules
8 Included
Support & Training
Available
Validation
Available
Free Trial
No
ETQ Reliance
ETQ Reliance is an easy-to-use QMS for enterprise organizations and those who aspire to be. It automates multiple quality management processes out-of-the-box or customized to meet your needs. Nine core modules are included and up to 42 ready-to-use applications are available.
Rated 4.2/5 on G2
Rated 4.6/5 on Capterra
Pros:
- Up to 42 applications available
- Cloud-based platform
- Out-of-the-box capabilities
- Customizable
- Concurrent-license pricing
- Supplier portal available
- ERP integration
Cons:
- Extra options have added cost
- Implementation and training are an extra cost
- Mixed reviews of customer support and training
- Reported lags in system
- No free trial
Core Modules
9 Included
(42 Available)
Support & Training
3 Plans Available
Validation
Available
Free Trial
No
Intellect
Intellect QMS is designed for companies with 100 employees or more as well as startups with funding. It includes four core applications, and it offers up to 28 pre-built applications that are configurable using a drag-and-drop feature. Intellect is a fairly well-rounded offering, however the base package is small and costs quickly add up as capabilities are added.
Rated 4.6/5 on G2
Rated 4.5/5 on Capterra
Pros:
- 4 core applications, with 14 additional available
- Drag-and-drop configuration
- Cloud or on-premise availability
- Customer support available
- Free trial available
Cons:
- Additional applications are an added cost
- API integrations are an additional cost
- No supplier or customer portals
- Reports of bumpy implementations
- Full customer support available for an additional cost
- Limited storage capabilities (25 – 300 GB)
Core Modules
5 Included
(30 Available)
Support & Training
3 Plans Available
Validation
Available
Free Trial
Yes
