BMR vs. MMR vs. eBR vs. eDHR – Key Differences in Regulated Manufacturing
Understanding the differences between a Batch Manufacturing Record (BMR), Master Manufacturing Record (MMR), Electronic Batch Record (eBR), and Electronic Device History Record (eDHR) is essential for manufacturers operating in regulated industries. These records aren’t interchangeable—they serve distinct compliance functions across pharmaceuticals, dietary supplements, cosmetics, food, and medical device sectors.
BMRs are the completed documentation of a batch, confirming execution of manufacturing steps and quality checks. MMRs are the pre-approved instructions that BMRs must follow. eBRs digitize BMRs to enforce accuracy and procedural control. eDHRs document production and testing for individual medical devices—critical under ISO 13485 and 21 CFR Part 820.
“If the MMR is the recipe, the BMR is the proof it was followed, and the eBR makes sure nothing is missed during execution.”
— MES Validation Lead
Master Manufacturing Record (MMR)
The MMR defines the manufacturing process in advance—covering equipment, materials, procedures, and critical control points. It ensures that every batch is made consistently. MMRs are required under 21 CFR Parts 210 & 211 and 21 CFR Part 111.
In V5, the MMR becomes a live digital template that governs batch execution across all modules—ensuring version control, procedural compliance, and audit readiness.
Batch Manufacturing Record (BMR)
The BMR captures everything that actually happened during batch execution—who did what, when, and whether it matched the MMR. It includes timestamps, deviations, sign-offs, and quality data. In GMP audits, the BMR is often the first document reviewed.
See full article: What is a BMR and why it matters?
Electronic Batch Record (eBR)
The eBR is a digital form of the BMR, enforced through software like V5 MES. It removes manual entry errors, enforces sequencing, and automates deviations and approvals—making real-time QA a reality. eBRs are key for 21 CFR Part 11 compliance.
For more, read eBR vs. Traditional Batch Records.
Electronic Device History Record (eDHR)
Used in medical device manufacturing, the eDHR tracks all activities associated with a specific unit or batch—materials, inspections, test results, and release status. It’s mandated under ISO 13485 and 21 CFR Part 820.
V5 Traceability makes eDHRs audit-ready and links them with upstream records like the MMR and BMR, ensuring complete batch visibility.
How These Records Work Together
Think of these records as a manufacturing stack:
- MMR – The approved process and quality plan
- BMR – The record of batch execution
- eBR – The digital enforcement and capture layer for the BMR
- eDHR – The complete historical record for device traceability
All are essential for full GMP traceability and electronic records compliance.
The V5 Advantage
Whether you manufacture pharmaceuticals, supplements, cosmetics, or medical devices, V5 from SG Systems Global delivers a unified platform to manage and connect your MMRs, BMRs, eBRs, and eDHRs. The result: faster batch release, better audit outcomes, and a stronger digital compliance posture.
Need to digitize your records or prepare for your next inspection? Contact us to learn how V5 simplifies batch documentation from start to finish.
