Pharmaceutical
Guarantee Pharma Compliance Using V5 MES, QMS & WMS Software
WHAT IS V5 TRACEABILITY?
Optimized Traceability for Pharmaceutical Manufacturing
Pharmaceutical manufacturing demands strict regulatory compliance, complete traceability, and rigorous control to ensure product integrity and patient safety.
V5 Traceability unifies Manufacturing Execution (MES), Quality Management (QMS), and Warehouse Management (WMS) into a single platform, streamlining operations while ensuring precision and compliance at every stage.
Designed for the complexities of regulated industries, V5 Traceability helps manufacturers meet global standards like GMP, Annex 11, and 21 CFR Part 11. By automating workflows, enforcing quality checks, and providing real-time insights, it reduces manual intervention, minimizes inefficiencies, and keeps operations audit-ready.
With built-in monitoring and compliance-driven tools, V5 Traceability significantly cuts non-conformance reports (NCRs), waste, and rework, making regulatory adherence seamless and efficient.
THE BENEFITS
Key Features and Benefits of V5 Traceability
V5 Traceability delivers measurable improvements across production, quality, and inventory management:
COST CONTROL
Streamline operations by automating manual workflows, reducing the likelihood of errors, and accelerating production cycles.
Compliance
Ensure adherence to stringent standards like GMP, Annex 11, and 21 CFR Part 11 with features like in-line quality control, eBR / eMMR, and robust audit trails.
SMART EFFICIENCY
From batching to packing, V5 automates scheduling, shortfall checks, and routing—keeping lines moving and labor optimized.
These benefits empower pharmaceutical manufacturers to deliver high-quality products efficiently, securely, and consistently.
MANUFACTURING EXECUTION
MES: Manufacturing Execution System for Pharmaceuticals
The MES module of V5 Traceability transforms production by enforcing process controls, improving efficiency, and ensuring quality at every step. Key features include:
Precision Dispensing & Formulation
Verified material identification and precise quantities for MMR accuracy.
Batch Production & Control
Step-by-step control ensuring consistent execution aligned to your MMR.
Real-Time Quality Checks
Immediate quality verification and data capture feeding directly into MMR documentation.
Electronic Batch Records (eBR)
Complete, compliant electronic documentation underpinning your finalized MMR.
Serialized Labeling & Packaging
Automated serialization and labeling data for accurate MMR compliance.
Built-In Regulatory Compliance
Integrated FDA 21 CFR Part 11 & cGMP adherence ensuring regulatory-ready MMRs.
With these features, pharmaceutical manufacturers can optimize production processes while maintaining full compliance with regulatory standards.
Quality management
QMS: Quality Management System
Quality is at the core of pharmaceutical manufacturing, and the QMS module of V5 Traceability ensures it is maintained throughout the process. Key features include:
Non-Conformance Reporting (NCR):
Automates NCR generation for failed batches and routes them to appropriate teams for resolution.
CAPA Management
Supports root cause analysis and corrective/preventive actions to resolve issues quickly.
Audits and Inspections
Streamlines GMP audit processes with pre-built templates and automated scheduling.
LIMS Integration
Manages lab testing data and integrates results directly into batch records.
Employee Training Management
Ensures personnel are qualified and certified for specific tasks, enhancing compliance.
Document Control
Centralizes document management, ensuring controlled access, version tracking, and regulatory alignment.
Deviation Control
Tracks and resolves deviations with automated workflows to ensure compliance and minimize disruptions.
Asset Management
Manages calibration schedules, equipment history, and maintenance records to maintain operational efficiency.
Customizable Approval Workflows
Ensures that critical stages in production and quality control are signed off by the correct personnel, preventing unauthorized actions. For instance, finished products cannot leave the facility without the approval of a Qualified Person (QP), ensuring adherence to regulatory and internal standards.
Controlled Drug Management
Implements robust processes for handling controlled substances, including storage, usage, and disposal, in compliance with regulatory requirements. This includes automated checks to ensure that controlled drugs follow the correct workflows, minimizing risks and enhancing traceability.
The QMS module integrates seamlessly with MES and WMS, providing a unified approach to quality and compliance.
Warehouse management
WMS: Warehouse Management System
Efficient inventory management is critical for pharmaceutical manufacturers, where precise control of raw materials and finished goods is essential. The WMS module of V5 Traceability provides:
Optimized Receiving & Putaway
System-guided receiving and placement rules maximize space utilization and operational efficiency.
Efficient Picking & Dispensing
Directed picking workflows streamline batch preparation and reduce fulfillment errors.
Order Fulfillment Accuracy
Precise pick, pack, and ship processes to guarantee correct product and documentation every time.
Real-Time Inventory Visibility
Live tracking and full visibility of stock levels, location, and movements across all warehouse operations.
Controlled Substance Security
Rigorous access control and tracking of controlled pharmaceutical substances, ensuring regulatory adherence.
Integrated Quality & Compliance
Seamless integration with MES/QMS ensures warehouse processes fully align with FDA cGMP and DEA regulations.
Batch & Lot-Level Traceability
End-to-end visibility and traceability from receiving through shipping for complete audit readiness.
Expiry & Shelf-Life Management
Automated monitoring ensures optimal inventory rotation, reducing waste and maintaining product efficacy.
Flexible Warehouse Configuration
Easily configurable workflows and storage strategies adapt to pharma-specific demands.
Automated Compliance Reporting
Automatic generation of compliance documentation and reporting simplifies regulatory audits and inspections.
HARDWARE
Hardware Integration
To create a fully connected production environment, V5 Traceability integrates seamlessly with production hardware and ERP / Accounting Systems.
CONNECT EQUIPMENT
Integrates with scales & bulk handling PLCs to automate production steps and enforce process accuracy in real time.
OPERATOR DEVICES
Utilizes industrial touchscreens and tablets for durable, on-floor interaction with workflows, data entry, and controls.
PRINT & SCAN
Enables barcode printing and scanning for labeled inventory, batch traceability, and seamless material movement.
By enabling seamless hardware integration, V5 Traceability ensures efficient production processes, minimizes manual errors, and enhances traceability across the manufacturing floor.
Connected Operations
Seamless ERP Connectivity
V5 Traceability connects your shop floor to your back office — linking production, inventory, finance, and fulfillment through seamless ERP connectivity with systems like NetSuite, Sage X3, Microsoft D365, and more.
What gets connected:
What gets connected:
Purchase Orders
Track inbound goods with PO-linked traceability — fully visible from dock to inventory.
Production Sync
Sync batch schedules and multi-level BOMs for better planning, allocation, and execution.
Sales Fulfillment
Link sales orders to picking, packing, and shipping workflows for accurate, on-time delivery.
V5 becomes your single source of truth — unifying departments with real-time, bidirectional ERP sync.
This boosts collaboration, ensures compliance, and sharpens operational performance.
Want the technical details? Dive in below — but fair warning: you’re about to enter the nerd zone (APIs, workflows, and real tech magic ahead..
Want the technical details? Dive in below — but fair warning: you’re about to enter the nerd zone (APIs, workflows, and real tech magic ahead..
SUMMARY
Why Choose V5 Traceability?
V5 Traceability is purpose-built to meet the specific needs of pharmaceutical manufacturers:
- Unified Manufacturing IntelligenceCombines MES, QMS, and WMS into one system—eliminating silos and streamlining every step from raw material to final product.
- Regulatory ConfidenceBuilt to meet FDA 21 CFR requirements with full audit trails, e-signatures, and real-time deviation tracking.
- Operational PrecisionAutomates critical workflows, prevents bad batches, and cuts manual errors—driving faster, leaner production.
- Scalable by DesignFrom single-site startups to global facilities, V5 adapts to any size or complexity with modular, pharma-ready tools.
By addressing the unique challenges of pharmaceutical manufacturing, V5 Traceability provides measurable value, from enhanced compliance to improved production efficiency.
Take the next step
Ready to optimize your pharmaceutical manufacturing operations?
V5 Traceability delivers the tools you need to ensure precision, compliance, and operational efficiency.
Streamline your operations with V5 Traceability - where compliance meets efficiency.
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