Manufacturing Execution System

Precision Execution for Regulated Manufacturing

INTRODUCTION

Control Every Batch. Cut the Paper. Nail Inspections

V5 MES is purpose-built for regulated manufacturing, digitizing batch execution, operator actions, and in-process controls in one system designed for FDA, ISO, and cGMP environments.

The result is faster batch release, fewer deviations, and end-to-end traceability you can defend in every audit.

WHAT TO EXPECT

The Core Benefits

Digitize quality. Speed up audits. Reduce risk.

V5 QMS simplifies compliance with faster batch execution, paperless records, and real-time traceability—built for regulated manufacturing.

PAPERLESS QUALITY CONTROL

Faster AUDIT PREPARATION

QUALTY TASK EXECUTION SPEED

FASTER BATCH CYCLE TIME

HARDWARE

Hardware Integration

Connect shop-floor hardware ↔ ERP.

CONNECT EQUIPMENT

Scales & PLCs. Automate steps. Enforce accuracy.

OPERATOR DEVICES

Touch panels & tablets for workflow control.

PRINTING SCANNING

Barcode print/scan for inventory & batch trace.

Scalable system integration

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MES Module Deeper Dive

V5 MES Module Overview
The Manufacturing Layer Built for & WMS Integration
Built-In Execution for Regulated Manufacturing
In pharma, food, and medical manufacturing, precision isn’t optional—it’s operational. That’s why V5 MES is deeply integrated with QMS and WMS, turning every batch, check, and movement into a controlled, traceable process. No paper. No delays. Just execution built to spec—by design.
V5 MES doesn’t just document what happened—it ensures it’s done right in real time. Whether you’re scaling ingredients, validating weights, or guiding operators through critical tasks, the system enforces every requirement from your MMR, SOP, and training matrix.
What You Get with Integrated MES + QMS/WMS
- Digitized Batch Execution — Automate batch workflows with controlled actions, step prompts, and embedded decision logic
- Live Yield & Material Tracking — Know what’s been used, scrapped, and consumed—down to the lot, time, and operator
- Enforced Process Steps — Guide users with hold points, QA checks, and real-time feedback that ensures every step is followed
- In-Line Device Integration — Weighing, scanning, and printing actions are captured and tied to the batch record automatically
- Automatic EBR Generation — Complete, compliant records are created during execution—no post-batch assembly needed
- Regulatory-Driven Workflows — Supports FDA 21 CFR Part 11, cGMP, and ISO requirements right out of the box
- Batch-to-Bin Traceability — Instantly track finished goods and intermediates from MES batches to WMS locations
Explore the Modules Below
From guided weighing and SOP-driven execution to in-process controls and digital EBRs—each MES module below helps eliminate human error, speed up production, and pass every audit with confidence. Dive into the details and see how V5 turns production into precision.
Production Planning & Scheduling
▮▯▯ Schedule jobs, route batches to correct work centers, and detect material shortfalls
Drive production with confidence—right from the start.
Effective manufacturing begins with a clear, flexible production plan. V5 gives you real-time control over job scheduling, routing, and material readiness—ensuring every batch moves through the right stages, at the right time, with the right resources in place. No guesswork, no blind spots—just live visibility into what’s running, what’s ready, and what needs attention.
Key Benefits:
- Schedule and release jobs with full visibility across production lines
- Automatically route batches to the correct work centers or zones
- Detect material shortfalls early to avoid delays and overproduction
- Prioritize orders based on due dates, material availability, or customer need
- Track production readiness by resource, formula, and shift
Keep your plant running smart—not just fast.
With V5, planning is no longer a static list—it’s a live, dynamic engine that aligns people, materials, and equipment. The result? Smoother workflows, better utilization, and fewer last-minute surprises.
Deeper? let’s get into it!!
Scheduling – Plan Jobs, Route Batches, Track Completion
The screen below shows the V5 Control Center’s Scheduling module, where planners create, route, and release production jobs with total visibility. Whether you’re assigning batches to specific lines, balancing load across dispensaries, or reviewing completion status—everything is centralized. With tools like batch-level weight checks, shortfall analysis, and allergen sequencing, V5 ensures your production plan is realistic, compliant, and ready to run.
Products & Formulations
▮▯▯ Build Products, Define BOMs, Standardize Execution
Design Every Product with Precision—Down to the Gram.
Product quality starts with consistency—and consistency starts with a well-defined formula. V5 lets you create and manage detailed BOMs and product formulations that drive repeatable results across every batch, shift, and site. From raw material specs to process instructions, your manufacturing logic becomes embedded in the system.
Key Benefits:
- Build recipes with target weights, tolerances, and ingredient attributes
- Assign production steps with precise instructions and processing zones
- Link materials to dispensing locations, blending equipment, and workflows
- Control base sizes, run times, expiry days, and batch yield parameters
- Validate every formulation with version history and approval tracking
Create with control, scale with confidence.
With V5, your formulas aren’t just documents—they’re operational blueprints. Whether scaling to new lines or enforcing recipe compliance, every product setup becomes a traceable, enforceable standard for production success.
Deeper? let’s get into it!!
Formulas – Build Products, Define BOMs, Standardize Execution
The screen below shows the V5 Control Center’s Formulas module, where you define every step of your product’s Bill of Materials and process instructions. Each formula includes target weights, tolerances, production messages, and equipment routing—all fully version-controlled. From active ingredients to excipients and blending instructions, V5 ensures each batch is made the same way, every time.
Checklist Automation
▮▮▮ Templates, schedules, and task tracking
Enforce task consistency with zero paper trails.
Checklists shouldn’t just live on clipboards—they should drive performance. V5 digitizes your operational checklists, standardizing execution across shifts and locations. Each checklist can trigger escalation logic, log deviations, and directly feed into your quality management workflows.
Key Benefits:
- Design reusable checklist templates for any process or line
- Assign severity levels, escalation rules, and expected responses
- Enable operators to execute checklists from plant floor dashboards
- Deviations automatically route to the Quality Issues module
- Schedule checklists and monitor completion in real time
From preventive tasks to regulatory checks—you’re covered.
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Whether it’s a pre-op inspection or a cleanroom validation, V5 checklists ensure nothing is missed, everything is tracked, and every deviation is captured.
Deeper? let’s get into it!!
Checklist Templates Setup
This screen displays the setup view for checklist templates in V5. Here, users can build reusable checklists with predefined questions, severity-based responses, and linked specification references. Whether it’s PPE compliance or equipment sanitation, templates are tied to jobs, locations, approval workflows, and scheduling rules—making standardized task execution effortless and audit-proof.
Plant Floor Execution & Specifications
This set of screens shows what execution looks like at the operator level. V5 walks users through each checklist step with visuals, spec-based response options, and real-time escalation triggers for non-compliance. NCRs are auto-generated, approvals are routed, and specifications are enforced through structured, guided interaction—ensuring consistency and compliance on the shop floor.
????Scheduled Checklists & Results Logging
The final view highlights checklist execution history and results. Supervisors can review which checks have been completed, which are pending, and which triggered deviations. Each response is timestamped, tied to a user, and linked to any relevant follow-up action. It’s a complete, traceable record that strengthens compliance and closes the loop between execution and quality assurance.
Material Prep & Label
▮▯▯ Guide operators through barcode-verified weighing and staging with tolerances and device integration
Prepare Every Ingredient with Confidence—Digitally Directed, Label Verified.
Material preparation in V5 is more than weighing—it’s a digitally enforced, fully traceable operation. From selecting the correct lot to achieving target weights within tolerance and generating compliant labels, every step is operator-guided and audit-locked. No manual logs. No guesswork. Just consistent, compliant prep.
Key Benefits:
- Select from approved, in-spec inventory by scanning or search
- Enforce material weights with live scale feedback and digital overs/unders
- Automatically generate batch-specific ingredient labels with QR traceability
- Capture operator attribution, container tare, and gross/net weights
- Lock-in data for MMR/EBR and label reconciliation
When accuracy matters, V5 leads.
With V5’s material prep, your process doesn’t just happen—it’s verified in real-time and recorded for the record. Whether dispensing for blending or staging for production, you get complete trust in every gram, every label, every batch.
Deeper? let’s get into it!!
⚖️ Material Prep & Label – Weigh Ingredients, Verify Lots, Print Labels
The screens below showcase the V5 Material Prep module in action, guiding operators through precise ingredient dispensing while enforcing compliance at every step. From live scale feedback and lot selection to automated label generation, every move is tracked and validated in real time. The label shown is generated post-weighing and includes batch-specific data—ingredient, lot, supplier, operator, expiration, and a QR code—ensuring full traceability and GMP-compliant packaging.
Batch Execution & Review
▮▯▯ Digitally execute batch steps with live checks and QA hold points. Auto-generate EBRs with sign-off workflows
Execute Every Batch with Confidence—Digitally Enforced, Operator Attributed.
V5’s Batch Execution module transforms production into a structured, compliant process where nothing is left to chance. Each step is defined by your formula, enforced by the system, and completed with operator attribution—so what happens on the floor matches what’s on the record. From mixing instructions and scan-to-confirm steps to automated timers and approvals, every action is logged, traceable, and ready for review.
Key Benefits:
- Step-by-step execution with enforced order and system-triggered controls
- Scan-based validation of ingredients, locations, and equipment
- Live timers and prompts for blending, sieving, and processing events
- Operator-specific signatures on every batch step and outcome
- Electronic review and approval workflow for QA and supervisors
- Automatic EBR generation with full traceability and audit trails
Build batches the right way, every time.
With V5, batch execution isn’t a checkbox—it’s a controlled operation where compliance, quality, and consistency converge. From first weigh-in to final sign-off, everything is digitally secured and inspection-ready.
Deeper? let’s get into it!!
Guide Production, Enforce Steps, Capture Sign-Offs
The screens below highlight V5’s Batch Execution module, where operators follow a digitally enforced recipe—step-by-step. From scanning bags and confirming ingredients to starting mixers and logging completion, each activity is tracked in real time with operator attribution. The system prompts when action is required, starts countdowns for time-based steps, and ensures no task is skipped or altered. Once complete, the batch is sent for electronic review and sign-off by QA and production leads, locking the data into the EBR. It’s MES execution the way it should be: compliant, clear, and fully accountable.
Process Monitoring & Predictive Analytics
▮▯▯Live SPC and anomaly detection to optimize throughput and reduce risk
Process Monitoring & Predictive Analytics
See Issues Before They Happen—Real-Time SPC, Trends, and Predictive Alerts.
V5’s Process Monitoring & Predictive Analytics module gives you live visibility into every production run. Instead of reacting after the fact, you can detect process drift, spot variability, and act on predictive warnings before they become deviations. Whether it’s a mixer running off-speed, a critical parameter trending out of spec, or yield losses creeping upward, the system flags the issue in real time—so you can intervene early, minimize waste, and keep production on track.
Key Benefits:
- Continuous monitoring of critical parameters with live SPC charts and alerts
- Predictive trend analysis to anticipate equipment or process drift
- Real-time anomaly detection with configurable thresholds
- Automatic logging of monitored data into the batch record
- Early-warning notifications to supervisors and QA for rapid response
- Integration with calibration and maintenance data for root-cause context
Turn insight into action.
With V5, process monitoring isn’t just passive reporting—it’s a proactive layer of protection that strengthens compliance and efficiency. By combining SPC, predictive modeling, and live shop-floor feedback, you’ll spot problems sooner, act faster, and reduce costly rework.
Deeper? Let’s Get Into It!
Watch Parameters, Catch Drift, Predict Failures.
The screens below highlight V5’s monitoring dashboards, where operators and supervisors see live SPC charts, process trends, and predictive risk scores in real time. If a critical value begins trending toward a violation, V5 alerts the operator and supervisor instantly, prompting corrective action before a deviation occurs. Historical data is trended automatically, feeding predictive models that highlight repeat offenders (equipment, materials, or operators) and suggest preventive maintenance. Each data point is time-stamped, attributed, and secured—flowing directly into the electronic batch record.
It’s MES monitoring the way it should be: not just compliance for today, but foresight for tomorrow.
Assets & Equipment Management
▮▮▮ Keep Equipment Compliant—Tracked, Calibrated, and Production Ready.
In V5, assets aren’t just listed—they’re managed, monitored, and tied directly into production execution. Every scale, mixer, filler, and cleanroom device is tracked with usage logs, calibration history, and maintenance schedules. Operators can only use calibrated equipment, spare parts are linked to inventory, and preventive maintenance tasks are automatically scheduled before downtime occurs.
The screen below shows how V5 integrates equipment data with production workflows, ensuring each asset is validated and ready before it’s used. From calibration sign-offs to maintenance status, nothing is left to chance.
Key Benefits:
Centralized register of all assets, equipment, and tooling
Automated calibration scheduling with enforced lockouts on overdue assets
Preventive maintenance plans tied to usage hours, cycles, or time intervals
Spare parts ordering and consumption tracking linked to WMS inventory
Real-time visibility into equipment status (available, under maintenance, out of calibration)
Full traceability of asset history linked to batch records for compliance audits
V5 makes assets accountable.
Instead of reacting to equipment issues or missing calibration logs, you’ll have a live system that enforces readiness, prevents downtime, and proves compliance. With V5, assets aren’t just tracked—they’re controlled.
Packaging & Labeling
▮▯▯ Ensure correct pack-outs and compliant labeling with scan-to-confirm and serialization support
Full control over every pack-out and label.
Compliance doesn’t end with production—it extends to how your products are packaged and labeled. V5’s Packaging & Labeling module ensures that every carton, case, and pallet is correctly identified, serialized, and compliant with regulatory standards. From barcode verification to serialization tracking, each package is digitally tied to its batch history, giving you end-to-end traceability from shop floor to shipping dock.
Key Benefits:
Enforce scan-to-confirm labeling on every unit, case, and pallet
Integrate with printers, scanners, and vision systems for error-free packaging
Support for serialization and aggregation at multiple packaging levels
Generate and apply compliant labels automatically with live data feeds
Capture rework, relabeling, and packaging deviations with operator attribution
Provide regulators and auditors with full packaging traceability linked to EBRs
Your packaging is your product’s first impression. V5 makes it compliant.
Instead of relying on manual checks or siloed labeling software, you get a single system that validates packaging steps, prevents errors, and proves compliance—every time.
Deeper? Let’s Get Into It!
📦 Packaging Line Integration
This screen shows how V5 connects directly to packaging lines and devices. Printers, scanners, and label applicators are integrated into the workflow, ensuring each label is generated with real-time production data and verified before it leaves the line.
🔗 Serialization & Aggregation
Here, V5 manages serialization at the item, case, and pallet level. Unique IDs are generated, tracked, and aggregated into parent/child hierarchies for complete downstream traceability. Whether it’s pharma DSCSA or food labeling requirements, V5 handles the structure automatically.
✅ Scan-to-Confirm Accuracy
This view highlights scan-to-confirm controls. Operators scan each label or package to confirm correctness, reducing risk of mislabeling or mix-ups. If a discrepancy is found, the system blocks progress and routes a deviation to QA.
♻️ Rework & Relabeling Controls
This screen captures packaging corrections, such as relabeling or reboxing. Each action is logged with operator attribution and timestamped for audit readiness. By capturing rework events, V5 preserves packaging integrity while maintaining compliance.
🚚 Shipping-Ready Traceability
This section shows how packaging data links directly to logistics. Every serialized unit is tied to the shipment, ensuring end-to-end visibility from production floor to distribution center.
Quality Issues
▮▮▮ Deviations, CAPAs, complaints
Turn deviations into improvement opportunities.
When something goes wrong, how fast you respond matters. V5 centralizes all quality issues—NCRs, complaints, CAPAs—into one auditable space. Root causes are linked, corrective actions are tracked, and escalation is built-in. Every record contributes to a cycle of continuous improvement.
Key Benefits:
Log, categorize, and assign deviations with role-based workflows
Connect NCRs to products, equipment, or SOP failures
Route CAPAs with deadlines, escalation triggers, and resolution logs
Capture root cause analysis directly in the system
Maintain full audit trails with timestamps, users, and actions
Don’t just manage issues—resolve them, improve from them, and prevent recurrence.
V5 transforms reactive firefighting into structured quality management, giving you control, accountability, and proof of resolution every step of the way.
Deeper? let’s get into it!!
Quality Issues
This screen showcases V5’s centralized Quality Issues dashboard, where every deviation—whether from a checklist, batch start, or audit—is logged, categorized, and escalated in real time. Users can assign severity levels, link to QA responses, and trigger official actions with full traceability. With built-in audit trails, user accountability, and escalation paths by group or role, V5 ensures that quality issues are not only captured—they’re resolved, documented, and closed with confidence.
Operator Authentication
▮▯▯ Capture every action with user-level attribution—full traceability, complete accountability
Authenticate with Confidence—Digitally Controlled, Role Verified.
Operator access in V5 isn’t just a login—it’s a safeguard for your entire manufacturing process. Every user is authenticated, qualified, and permissioned based on role, ensuring that only trained personnel can execute critical tasks. From login attempts and password expirations to role-based restrictions and training validation, every interaction is locked to an identity. Whether it’s batch approval, deviation review, or packaging sign-off, you know exactly who did what, when—and that they were authorized to do it.
Key Benefits:
Secure login with password
Role-based access tied to job functions and responsibilities
Operator group assignments for streamlined permission control
Automatic enforcement of training requirements for specific tasks
Complete action traceability with user attribution and timestamps
V5 keeps your people and processes in sync.
With operator authentication built into every workflow, you eliminate guesswork, prevent unauthorized actions, and meet regulatory demands with confidence—every signature, every step, digitally secured.
Deeper? let’s get into it!!
Operator Login – Secure Authentication with Role-Based Controls
The screens below show V5’s login and authentication flow, ensuring that only authorized, trained personnel gain access to the system. From user ID entry and password validation to multi-step confirmation for batch approvals, every action is traceable to a verified individual. Failed attempts, password expiries, and approval requests are all logged in real time—meeting the demands of CFR Part 11 and reinforcing accountability across the floor.
???? Operator Groups – Define Roles, Permissions, and Quality Gates
This screen from the Operator Group setup in V5 shows how user roles are managed within predefined groups. Whether assigning QA, Production, or Warehouse responsibilities, each group governs access to modules, functions, and approval authority. It’s a scalable way to enforce segregation of duties, streamline group-level policies, and keep teams focused on what they’re cleared to do—nothing more, nothing less.
Operator Profiles – Track Credentials, Expiry Dates, and Authorizations
Here you see V5’s Operator Master List, where every user’s credentials, training status, and supervisory role are visible at a glance. Training expiration dates and password cycles are proactively managed to prevent non-compliant access. Operators can’t proceed unless they’re qualified, and every action—from logins to approvals—is logged with full attribution. It’s compliance made automatic—no spreadsheets, no slip-ups.
Process Variability Tracking
▮▯▯ Track yield loss, rework, and material adjustments across batches for process optimization and audit clarity
Track Every Shift in the Process—Digitally Logged, Root Cause Ready.
In V5, process variability isn’t hidden—it’s captured, contextualized, and linked to the batch history in real time. Whether it’s a weight adjustment, out-of-spec input, or unexpected material substitution, every deviation is documented with operator attribution, timestamp, and justification. This isn’t just record-keeping—it’s live production intelligence.
The screen below shows how V5 logs process changes and material flows, highlighting events like over/under weighs, rework causes, and manual interventions. With complete traceability from start to finish, you can monitor yield loss, troubleshoot bottlenecks, and drive continuous improvement directly from batch data.
Key Benefits:
Real-time visibility into every batch deviation, adjustment, and operator action
Full traceability from raw material lots to final output
Integrated review and sign-off steps for each variance event
Operator-attributed actions with justification and timestamps
Seamless integration with MMRs/EBRs for audit readiness and batch investigation
V5 makes variability manageable.
Instead of guessing why a yield dropped or a batch ran long, you’ll have the data—linked, timestamped, and ready to act on. With V5, your process isn’t just controlled—it’s understood.
Deeper? let’s get into it!!
Process Variability Tracking – Capture Deviations, Monitor Trends, Improve Outcomes
The screen below showcases how V5 logs and contextualizes real-time deviations within a batch. From ingredient substitutions and weigh tolerances to batch yield shifts and manual overrides, every process variation is automatically captured and linked to its originating event. With visibility into operator actions, timestamps, and material-level traceability, your team gains the insight needed to understand, resolve, and prevent inconsistencies—turning production data into quality-driven decisions.
Environmental & Cleanroom Monitoring
▮▮▮ Monitor temperature, humidity, and particulates with alerts linked to QMS checklists
Maintain Every Environment—Monitored, Validated, and Audit-Ready
In V5, cleanroom and environmental controls aren’t an afterthought—they’re fully integrated into execution. Temperature, humidity, pressure differentials, particle counts, and microbial readings are continuously monitored. Any deviation triggers automatic holds, alerts, or corrective tasks until conditions are validated. This isn’t just monitoring—it’s compliance and process control built in.
Operators always see live environmental status at each workflow step. Out-of-spec events auto-generate tickets, logs are timestamped, and supervisor/QC review is enforced. All data is linked back to batch records and ready for audit.
Key Benefits:
Continuous capture of all relevant cleanroom and environmental parameters
Enforced lockouts or holds for out-of-spec conditions
Automated corrective tasks and escalation paths
Real-time visibility across zones
Full traceability of environmental history tied to batch records
Audit-ready reports of excursions, trends, and compliance events

V5 doesn’t just log environment data—you control it. With V5, every cleanroom parameter is tracked, validated, and inspection-ready—before a single batch is run.
KPI Dashboard
▮▮▯ Live production metrics in one dashboard—perfect for efficiency monitoring!
Complete visibility into quality performance—at a glance.
V5’s Quality KPI Dashboard brings real-time insight to every corner of your quality system. Whether you’re tracking open NCRs, overdue checklists, pending process deviations, or training compliance gaps, the dashboard surfaces the data that matters most—instantly. It’s a live control panel for QA leaders, transforming fragmented spreadsheets and manual reports into a single, actionable view.
Key Benefits:
- Monitor open NCRs, deviations, CAPAs, and checklist completion rates in real time
- View compliance performance by product line, area, or operator group
- Instantly identify bottlenecks, overdue actions, or missed training deadlines
- Drill down from high-level stats to individual quality events or SOPs
- Export ready-to-audit reports with timestamps, user traceability, and resolution history
When quality issues arise, speed and visibility are everything.
V5 gives you both—before issues escalate, audits slip, or compliance falters. It’s proactive QA, driven by data and built for regulated operations.