batch records and traceability resources center

Batch Records & Traceability

Resources

COMPLIANCE

Records That Matter

Built for the Shop Floor. Trusted by Regulated Manufacturers.

This section highlights the core reports that drive compliance in regulated manufacturing. From BMRs and MMRs to eBRs, CoAs, and eDHRs, each topic explains what the record is, why it matters, and how V5 enforces traceability and compliance at every step.

About this Page
An overview of what you'll find below
What’s Inside
Regulated manufacturers know documentation isn’t just paperwork—it’s proof of compliance. This page covers the core batch record types—BMR, MMR, eBR, DHR/eDHR, and CoA—and shows how V5 enforces cGMP, 21 CFR Part 11/Annex 11 and QMSR with ALCOA+, robust audit trails, and clean record retention.
Jump to: Core Records • Data Integrity & Validation • Traceability & Serialization • Quality Events & Release • Lab & Testing • Warehouse & Logistics • Operations & Performance • Standards & Programs • Industry Use Cases • Integrations • Further Reading • Glossary A–Z
Core Compliance Records
Foundational documents for GMP, ISO, and FDA/EMA compliance.
Batch Manufacturing Record (BMR)
The BMR captures every critical production step—from material issuance to final packaging—serving as the definitive log for batch compliance. V5 enforces SOPs, captures audit trails, and supports electronic signatures per Part 11/Annex 11. Deep dives:
What a BMR is & why it matters BMR vs MMR vs eBR vs eDHR Glossary: BMR Weighing & dispensing controls Batch genealogy Verification & Validation
Master Manufacturing Record (MMR)
The MMR defines how to make the product—consistently and compliantly. V5 turns the MMR into an enforceable template with controlled recipe management, versioning, and approvals. Deep dives:
MMR & GMP compliance Glossary: MMR Formula control & scales Recipe formulation system
Electronic Batch Record (eBR)
eBR replaces paper with digital enforcement: real‑time data capture, conditional checks, and instant deviation triggers. It shortens review/release while improving data integrity under ALCOA+. Deep dives:
eBR vs paper eBR software eBR systems eBR for pharma Glossary: eBR Why paper dies in GMP
Certificate of Analysis (CoA)
The CoA consolidates lab results and acceptance criteria linked to the batch. V5 ties test results, ID tests, and method validation to the final document—no retyping, no errors. Deep dives:
CoA explained (post) Glossary: CoA Sample labeling & LIMS scheduling ISO 17025 accreditation
Electronic Device History Record (eDHR)
eDHR is non‑negotiable for medical devices. V5 captures serial numbers, calibrations, inspections, and device‑level attributes to streamline legacy 820/QMSR and EU MDR. Deep dives:
From manual to eDHR 21 CFR 820 / QMSR overview ISO 13485 quality Glossary: DHR Glossary: UDI
Data Integrity & Validation
Regulator‑proof records, signatures, and validation evidence.
21 CFR Part 11 & Annex 11
V5 enforces Part 11 and Annex 11 with ALCOA+, tamper‑evident audit trails, role‑based access, training matrices, and long‑term archival.
Part 11 compliance (post) Annex 11 compliance (post) Glossary: Data Integrity Document control
GAMP 5 & Computer System Validation
V5 supports risk‑based validation aligned to GAMP 5 and CSV deliverables—URS, VMP, IQ/OQ/PQ/Verification, UAT, and TMV.
GAMP 5 software validation Verification & Validation Validation Master Plan
Traceability & Serialization
Lot genealogy, FSMA 204, DSCSA, GS1, and EPCIS—end to end.
FSMA 204 & Food/Ag Traceability
V5 captures Key Data Elements (KDEs) and maintains end‑to‑end genealogy, using EPCIS and GS1‑128/SSCC/GTIN with the right Application Identifiers.
FSMA 204 with V5 Meet FSMA 204 Produce packing & FSMA 204 BRCGS 3.9 SQF Edition 9 PTI
Pharma DSCSA & Medical Device UDI
For pharma, V5 supports DSCSA lot/pack serialization and interoperable exchange. For devices, V5 manages UDI labeling and data capture across manufacturing and distribution—aligned with EU MDR and AusUDID.
eDHR & UDI in practice Label verification/UDI checks Serialization overview
Logistics Signals that Matter
Traceability is nothing without clean handoffs. V5 drives ASNs, dock‑to‑stock, shipping manifests, and BOL—with OTIF tracking.
EDI/ASN integration Global batch traceability
Quality Events & Release
Deviations, CAPA, OOS/OOT—and clean, defensible release decisions.
Deviations, NCR/NCMR, OOS & CAPA
V5 captures deviations, NCR/NCMR, OOS/OOT, and drives CAPA with linked RCA and effectiveness checks.
Notification of Change (NoC) Change control QRM & risk register Quality Assurance
Quarantine, Disposition & Batch Release
Manage quarantine/holds, and complete QA disposition with full lineage back to tests and CoA. When it’s ready, perform batch release and finished goods release with one source of truth.
Batch record review (post) PQR APR
Lab & Testing
From method validation to CoA—without retyping or gaps.
LIMS, ISO 17025 & Method Validation
Integrate with your LIMS, align to ISO/IEC 17025, and lock in TMV so test data flows straight into the BMR/eBR and CoA.
Sample labeling & LIMS scheduling ISO 17025 accreditation Lab tests & reviews
Process Monitoring
Bring PAT, EM, and temperature mapping into routine control. For APIs and pharma, align to ICH Q7/Q10.
21 CFR 210/211 (post) ICH Q7 compliance (post) ICH Q10 PQS (post)
Warehouse & Logistics
Accuracy in, accuracy out—because release depends on it.
WMS, FEFO/FIFO & Receiving Controls
V5 streamlines WMS: bin locations, directed put‑away, directed picking, FIFO/FEFO, and cycle counts.
Quality‑enforced receiving Pack & ship Advance Shipping Notice (ASN)
Labeling & Compliance
Maintain compliant labels across industries: barcode verification, GS1‑128, SSCC, and GTIN.
Compliant order fulfillment Shipping manifest Bill of Lading
Operations & Performance
Recipe control, dosing accuracy, SPC/OEE—and the metrics that matter.
Recipe & Weighing Controls
V5 enforces master recipes, batch weighing, micro‑ingredient/macro dosing, potency adjustment, and line clearance.
Batch weighing system Formula control & scales Ingredient management
Scheduling, SPC & OEE
Drive finite‑capacity scheduling, monitor SPC (X‑Bar/R, Cp/Cpk, UCL), and track OEE—because what isn’t measured isn’t improved.
Real‑time compliance Cut COPQ with V5 KPI fundamentals
Related Topics
Systems that reinforce traceability, review speed, and compliance.
Traceability Systems
V5 provides complete traceability across ingredients, equipment, and packaging—from raw intake to shipment—aligned with end‑to‑end genealogy, EPCIS, and GS1 standards. View article
Batch Record Review
Review by exception cuts cycle time from days to minutes. V5 highlights missing data, flags deviations, and supports e‑approvals—so QA focuses on risk, not paperwork. View article
BMR / MMR / eBR / eDHR Comparison
Side‑by‑side comparison for QA leads, auditors, and system integrators—how BMRs, MMRs, eBRs, and eDHRs relate, differ, and integrate. View article
Industry Use Cases
How batch records and traceability apply across manufacturing environments.
Pharmaceutical Manufacturing
V5 supports Part 11, 211, ICH Q10, and QbD—with validated eBR workflows. View use case
Medical Device Manufacturing
Enforce QMSR/ISO 13485, track device‑level history, and automate compliant eDHRs with UDI control. View use case
Dietary Supplement Manufacturing
Meet 21 CFR 111 with enforced batching, weighment, and documentation across blending and packaging. View use case
Bakery Manufacturing
Improve lot tracking, allergen control, and production efficiency using real‑time traceability; align to BRCGS and SQF. View use case
Closing Thoughts
Why this matters and what to do next
What V5 Delivers
From GMP manufacturing to FDA‑regulated labeling, V5 makes batch documentation compliant, complete, and review‑ready. With electronic records & signatures, real‑time traceability, and live audit trails, quality teams get control without slowing production. If your current process relies on paper or after‑the‑fact data entry, that’s a liability—fix it before an audit does it for you.

Choose a System That Works Where It Matters Most

V5 Traceability isn't just another compliance tool — it's how top manufacturers take control of production, protect quality, and build a more profitable future.

OUR SOLUTIONS

Discover the V5 Product Suite