Electronic Batch Records (eBR) vs. Batch Records – Compliance, Control, and the Digital Advantage
Electronic Batch Records (eBR) offer manufacturers a modern alternative to traditional paper-based batch documentation. By automating data entry, enforcing sign-offs, and creating a tamper-proof audit trail, eBRs help regulated companies meet 21 CFR Part 11 and global GMP expectations with less risk and faster batch release. Unlike traditional batch records, eBRs enable real-time data capture and enforce procedural compliance as production happens—not after the fact.
Batch Manufacturing Records (BMR), often referred to as Batch Production Records (BPR), have long been the foundation of pharmaceutical, supplement, and medical device manufacturing. But in high-risk environments, paper records expose manufacturers to data integrity risks, missed sign-offs, and avoidable delays. That’s why more operations are moving to eBRs powered by solutions like V5 from SG Systems Global.
“Paper batch records delay our release schedule. With eBRs in V5, we know every step is completed, signed, and ready to release—immediately.”
— Operations Director, Nutraceutical Manufacturer
What Is a Batch Record?
A traditional batch record is a paper document that outlines the materials, equipment, personnel, and procedures used to produce a batch. It includes process parameters, weight checks, line clearance, inspections, and sign-offs. It’s required by GMP regulations to prove each batch was produced according to the Master Batch Record (MBR).
But paper-based batch records are often:
- Prone to illegible handwriting and missing data
- Completed after production rather than in real time
- Dependent on manual oversight to catch deviations
- Slower to review, with delayed QA approval
What Is an Electronic Batch Record (eBR)?
An eBR is the digital version of a batch record, capturing production data automatically from operator inputs, machines, and software systems. It enforces the approved manufacturing process electronically—requiring the right person to perform the right step, at the right time, with the right materials.
eBRs provide:
- Real-time visibility of batch progress and compliance
- Electronic signatures per 21 CFR Part 11
- Built-in checklists, validations, and escalation workflows
- Automated deviation capture and CAPA linkage
- Faster review and release processes
eBRs go beyond digitized paper—they create enforceable, timestamped, audit-ready records. If you’re operating in a highly regulated environment, it’s the foundation of digital GMP compliance.
eBR vs. Batch Record – Key Differences
| Feature | Traditional Batch Record | Electronic Batch Record (eBR) |
|---|---|---|
| Format | Paper/manual | Digital/system-based |
| Audit Trail | Handwritten notes | Timestamped, automated |
| Signatures | Wet ink, prone to omission | Electronic, enforced |
| Review Time | Days | Minutes to hours |
| Deviation Tracking | Manual, post-process | Live, escalated |
V5: Enforced Compliance with eBR
V5 from SG Systems Global digitizes batch records across manufacturing, packaging, QA, and release. It enforces compliance at every step through role-based access, electronic checklists, material verification, and live data capture from the shop floor.
V5 supports:
- Electronic Batch Records (eBR) with secure sign-offs
- Deviation and CAPA escalation logic
- Checklist automation with timestamps and role validation
- Integration with ERP, MES, and quality systems
- Electronic Device History Records (eDHR) for med device manufacturers
Whether you’re managing dietary supplements, pharmaceuticals, or medical devices, V5 ensures that no batch proceeds without verified, compliant documentation.
Is an eBR Required by Law?
No—but the requirements that eBRs fulfill absolutely are. Regulations like 21 CFR Part 11, ISO 13485, and EU Annex 11 require traceability, electronic records management, version control, and secure audit trails. While paper can technically meet these under perfect conditions, eBRs make them practical and defensible.
And in an audit or FDA inspection, **if you can’t prove it, it didn’t happen.**
Start the Transition to eBR with V5
Don’t wait for your next deviation, rejected batch, or failed audit to modernize your batch record process. With V5, you get live visibility, faster release, and bulletproof traceability—all in a platform engineered for regulated industries.
Contact us today to schedule a demo or request a sample eBR. We’ll show you how V5 turns compliance into a competitive advantage.
