Batch Records & Traceability

Regulated manufacturers know that documentation isn’t just paperwork—it’s proof of compliance. This page explores the most critical batch record types used in GMP and FDA-regulated industries and explains how digital systems like V5 simplify traceability, reduce batch release times, and enforce data integrity at every step.

The BMR captures every critical production step—from material issuance to final packaging—serving as the definitive log for batch compliance. V5 ensures that SOPs are enforced, signatures are applied electronically, and audit trails are maintained without manual work. View article

The MMR defines the instructions for making a product consistently and compliantly. V5 uses the MMR to create enforceable batch templates, control operator behavior, and ensure each run follows validated procedures. View article

eBR replaces traditional paper records with digital enforcement. With V5, operators record data in real time, triggering alerts and conditional checks that reduce deviations and accelerate batch release. View article

CoAs validate the quality of a batch by summarizing lab results and acceptance criteria. V5 automatically links batch test results to the CoA output—ensuring document accuracy and traceability from lab to lot. View article

eDHRs are mandatory for medical device manufacturers. V5 captures serial numbers, calibrations, inspections, and device-specific attributes as part of an electronic record trail—streamlining 21 CFR Part 820 and ISO 13485 compliance. View article

V5 provides complete traceability across ingredients, equipment, and packaging—from raw material intake to shipment. This functionality is essential for complying with FSMA, BRC, SQF, and global food or pharma regulations. View article

Digitizing your batch review process with V5 reduces review time from days to minutes. The system highlights missing data, flags deviations, and supports electronic approvals—ensuring readiness for release and audit. View article

Need a side-by-side breakdown of batch documentation types? This article explains how BMRs, MMRs, eBRs, and eDHRs relate, differ, and work together. Ideal for QA leads, auditors, or system integrators comparing workflows and compliance strategies. View article

Explore how V5 supports pharmaceutical companies with 21 CFR Part 11 compliance, recipe enforcement, and audit-ready documentation. View use case

See how V5 enforces ISO 13485 controls, tracks device-level history, and automates the creation of compliant eDHRs. View use case

Discover how supplement producers use V5 to meet FDA 21 CFR Part 111, enforce batch precision, and manage documentation across weighment and blending. View use case

Learn how bakeries improve lot tracking, allergen control, and production efficiency using V5’s real-time traceability tools. View use case

From GMP manufacturing to FDA-regulated labeling, V5 ensures every detail of your batch documentation is compliant, complete, and review-ready. With support for electronic records, real-time traceability, and deviation tracking, V5 helps quality teams take control of batch records without slowing down production.