Streamline Compliance with QT9 ERP Electronic Batch Records

Manufacturers operating in regulated industries must manage detailed batch documentation to prove product safety, quality and consistency. From pharmaceuticals and supplements to cosmetics and food processing, batch records play a major role in meeting regulatory requirements for hundreds of industries worldwide.

QT9 ERP is electronic batch record software that delivers a modern, digital approach to batch record management. With electronic batch records (EBRs) built directly into production workflows, QT9 helps manufacturers meet global regulatory requirements, all while improving efficiency and reducing errors.

Contents

What is an electronic batch record?

Why electronic batch records?

Top features of electronic batch record software

Benefits of EBRs for manufacturers

Get started with electronic batch records in QT9 ERP

What is an electronic batch record?

An electronic batch record replaces traditional paper-based batch record documentation, which details the entire manufacturing process for a specific batch of a product, including raw materials and equipment used, as well as procedures followed. EBRs use a secure, digital system that captures production and quality data in real time. Key information included:

• Raw materials
• Procedures
• Operator inputs and approvals
• Quality check and test results
• Any deviations

By digitizing this information, manufacturers gain better control, faster access to records, and improved audit readiness than they would be able to with paper documentation.

Why electronic batch records?

Electronic batch records simplify and centralize documentation showing how a product is manufactured, tested and released. They serve as proof that each product meets required specifications and was produced under controlled conditions. These records are essential for demonstrating compliance with regulations and quality standards around the world.

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) and Health Canada, require manufacturers to maintain complete, traceable records for each batch. Without proper documentation, companies may face fines, recalls or halted production.

Manufacturing batch records are especially important in industries where product consistency, safety, and traceability impact consumer safety and are, therefore, non-negotiable, including:

• Pharmaceuticals – to meet GMP and 21 CFR Part 11 requirements
• Biotechnology – to ensure reproducibility and regulatory validation
• Food and Beverage – for traceability and safety regulations like FSMA
• Cosmetics and Personal Care – to track formulations and quality controls
• Chemical Manufacturing – to document hazardous material handling and blending procedures

EBRs make this process much more efficient than paper-based or unconnected legacy software. By maintaining detailed electronic batch records that are connected to related workflows, companies can ensure product integrity, support continuous improvement and remain compliant with global standards.

What are global EBR regulations?

Global compliance requirements that call for batch records include:

United States – cGMP

The FDA’s Current Good Manufacturing Practice (cGMP) regulations contain minimum requirements for the methods, facilities and controls used in manufacturing, including thorough batch records.

European Union – GMP

A core element of EU pharma legislation is the requirement to adhere to internationally accepted Good Manufacturing Practices (GMP), which call for detailed batch records.

Canada – Health Canada GMP Guidelines

Canadian regulations require complete batch records for pharmaceuticals and natural health products in alignment with GMP.

Latin America

Most Latin American countries follow GMP frameworks modeled after WHO and EU regulations and require traceable, documented batch production.

International – ICH Q7, ICH Q10, WHO GMP

ICH Q7 specifies requirements for the production, control and documentation of active pharmaceutical ingredients and mandates the creation of master production instructions and executed batch records. ICH Q10 emphasizes the importance of documentation throughout the product lifecycle, including batch records. The World Health Organization provides global guidance for GMP, which includes requirements for batch records.

By using a compliant EBR system like QT9 ERP, manufacturers simplify adherence to each of these frameworks while consolidating operations in a single platform.

Top features of electronic batch record software

Modern batch record software centralizes production, inventory control and quality data into a unified platform. Rather than managing batch documentation through disconnected spreadsheets, paper forms or separate systems, cloud-based EBR software allows manufacturers to streamline processes and maintain compliance from a single environment accessible from anywhere.

Real-time batch tracking across the production workflow

With EBR software, each batch is assigned a unique identifier and automatically tracked through every stage of production. This includes:

• Raw material sourcing and supplier details
• Work orders and step-by-step manufacturing processes
• In-process inspections and quality control tests
• Time-stamped operator approvals and electronic signatures

End-to-end traceability enables manufacturers to quickly respond to quality events, perform root cause analysis, or produce full documentation during audits or product recalls.

Guided digital workflows that support compliance

Electronic batch record software digitizes standard operating procedures and enforces workflow consistency across the production floor. Operators are guided through each step with built-in checks that ensure required actions are completed before progressing.

Key features often include:

• Mandatory field completion and validation rules
• Secure, compliant electronic signatures
• Automatic time-stamping and user action tracking

These capabilities help ensure that every batch is produced according to specification and meets the documentation requirements of global regulatory agencies.

Integrated quality control for seamless documentation

Quality checks are built directly into the EBR process. Manufacturers can:

• Link inspections and lab results to specific batch records
• Set up automatic holds or rework processes for failed inspections
• Log deviations and corrective actions as they occur

Storing quality data alongside production data eliminates silos and ensures full data integrity, tasks essential for compliance and continuous improvement.

Version control and document management

Global manufacturing regulations require current and validated documents be used during production. Leading electronic batch record platforms include document control features such as:

• Version-controlled SOPs and batch record templates
• Automatic retirement of outdated forms
• Complete change histories for audit transparency

These tools help ensure that teams always work from the latest approved documentation, whether you're meeting FDA 21 CFR Part 11, EU GMP or other international standards.

Audit-ready, wherever you operate

Preparing for inspections doesn't need to slow down operations. With all batch records stored digitally, manufacturers can:

• Instantly search and retrieve completed batch documentation
• Provide auditors with secure access to electronic records and audit trails
• Demonstrate compliance with regional regulations across North America, Europe, and Latin America

By consolidating data into a centralized batch record system, global manufacturers can standardize compliance processes while supporting the specific requirements of each regulatory body.

Benefits of electronic batch records for manufacturers

Digitizing batch records isn’t just about compliance, it also drives measurable business improvements.

Improved efficiency

Manual batch records are time-consuming to create, review and archive. EBR software like QT9 ERP eliminates redundant data entry by dynamically populating data. Automated controls also alert users to potential errors, identifying issues early and reducing rework and downtime.

Enhanced data accuracy

A cloud-based EBR system not only dynamically populates data, but also captures data in real time, ensuring that users are working with the most up-to-date, accurate information. What’s more, EBR software minimizes the risk of transcription errors and missing information.

Better collaboration

Production, quality and management teams can all access real-time batch-records data from any location. This improves communication, supports faster decision-making, and ensures alignment across departments.

Faster time to market

Streamlined documentation processes mean faster batch approvals and product releases. With everything stored digitally, there's no delay in gathering signatures, reviewing test results, or generating compliance reports.

ERP inventory management software not only provides real-time insight into inventory availability and location, it also provides real-time data about inventory costs and value. By keeping track of inventory in real time, businesses get a more accurate accounting of potential opportunities and costs. Integrated systems allow for the automatic generation of reports, giving management access to the data they need for better decision-making and cash flow management.

Get started with electronic batch records in QT9 ERP

Transitioning from paper to digital batch records may seem like a significant change, but with QT9 ERP, it’s a straightforward process. Our cloud-based platform is easy to configure and backed by 24/7 expert support. Users can create custom batch templates, create workflows and integrate quality control processes all in one centralized system.

Plus, because QT9 ERP can connect inventory, purchasing, scheduling and quality management, users can get a complete view of your production operations with minimal effort.