Quality Management System

Built-In Quality for Regulated Manufacturing

In pharma and life sciences, quality isn’t a department—it’s the system. That’s why V5’s QMS modules are fully integrated with MES and WMS, delivering operational quality control at every step of your manufacturing and inventory workflows. No silos. No spreadsheets. Just real-time enforcement of compliance, directly within your daily operations.

With V5, quality is not something you track after the fact—it’s something the system enforces in the moment. Whether you’re issuing batches, performing line checks, or moving high-risk inventory, QMS drives the rules that govern execution.

What You Get with Integrated QMS + MES/WMS

• Digital MMRs & EBRs — Every batch record is fully traceable, version-controlled, and linked to approved SOPs and trained operators.
• Real-Time Line Compliance — From pre-op checks to allergen tracking, quality enforcement is baked into every production step.
• Role-Based Training Validation — Operators can’t act unless they’re certified—automatically enforced by the system.
• Controlled Material Movements — WMS inventory actions are guided by quality status, shelf-life controls, and documented checks.
• Deviation to CAPA Resolution — Every non-conformance is traceable to the source and tied to a documented resolution path.
• Audit-Ready by Design — Review every action, signature, training status, and change history without lifting a binder.
• Plant-Wide Quality Visibility — Dashboards and logs connect QA, production, and inventory into one unified quality system.

Explore the Modules Below

From SOP enforcement and training management to lab testing, CAPAs, and asset tracking—each module below plays a critical role in embedding quality into your operations. Click into each one to see how V5 turns documentation into action, and compliance into a competitive advantage.

Lay the foundation for operational integrity—digitally.
Every compliant operation starts with a well-structured, enforceable set of policies and SOPs. V5 transforms how you manage this critical documentation, replacing static files with dynamic, role-driven procedures that connect directly to your daily operations. With built-in controls and centralized access, your team won’t just follow SOPs—they’ll live them.

Key Benefits:

• Centralized control of policies, terms, and SOPs in one unified system
• Build SOPs with step-level tasks, roles, and interlinked system actions
• Link SOPs to specific products, batches, or assets for full traceability
• Ensure compliance with FDA, ISO, and cGMP requirements
• Real-time visibility into version status, approvals, and audit readiness

Stay ahead of auditors and aligned across teams.
With V5, your SOPs aren’t static—they’re alive, integrated, and automatically maintained. You can confidently navigate inspections knowing every step is documented, assigned, and traceable.

Deeper? let’s get into it!!

????Policies – Setup Policies, Terms & Definitions, Link to SOP’s

The screen below shows the V5 Control Center’s Policies & SOPs view, where users can manage compliance-critical documents in one place. From version tracking and status indicators to linking SOPs by policy, it’s built for real-time visibility and structured accountability—perfect for staying audit-ready at all times.

????SOP’s – Setup SOP’s, Build Inter-Object SOP Steps & Assign Responsibility

This view drills down into the SOP configuration interface within V5’s Control Center. Here, users can define SOP headers, assign responsibility groups, and break procedures into linked, inter-object steps—like training modules, QA checks, or equipment tasks. It’s structured SOP management that turns documentation into action, ensuring compliance is enforced at every level.

Never lose track of qualifications again.
Keeping your workforce trained isn’t just good practice—it’s a regulatory mandate. V5 automates the training lifecycle, from module creation to test execution and result logging. With AI-assisted tools and built-in escalations, your team stays qualified while your QA team gains full visibility into progress and gaps.

Key Benefits:

• AI-powered creation of training modules and pass/fail testing
• Tracks operator scores, training history, and recertification timelines
• Escalates non-compliant results automatically via NCR workflows
• Schedules training by role, department, or custom logic
• Maintains detailed logs for internal audits or external inspections

Turn training into your strongest compliance asset.
V5 makes it easy to prove competence across your operation—without chasing spreadsheets or buried records. From onboarding to continuous improvement, every training moment becomes auditable and efficient.

Deeper? let’s get into it!!

????Training Module Setup – Powered by AI
This screen highlights how training modules are configured in the V5 Control Center. Each module includes a defined scope, scoring logic, and recurring schedule, ensuring that critical knowledge areas are revisited regularly. Questions and answers can be weighted for complexity, and linked resources support knowledge retention. With AI-assisted setup, QA managers can rapidly build tailored modules for GMP, SOPs, equipment use, and regulatory topics—making compliance training scalable and structured.

????Operator Training & Test Screens
The second view showcases the operator interface during training execution. Users select assigned modules from their dashboard, complete randomized test questions, and receive instant results. Failures automatically trigger NCRs and block access to production environments, while passing results generate certification with system-enforced expiration. This flow not only validates comprehension—it enforces accountability by tying training directly to MES access.

????Training Schedule & Logs
The final screen provides a complete audit trail of training performance. Supervisors can assign modules, monitor due dates, and instantly see which tests were passed or failed. Every question, answer, and certification is logged—ensuring airtight records for FDA, ISO, or internal audit readiness. With this level of visibility, training moves from a checkbox task to a fully managed compliance process.

Centralize your critical documents—no more chaos.
From SOPs and MSDS to COAs and supplier manuals, V5’s Document Control module brings order to the most compliance-sensitive content in your business. Everything is versioned, approved, and secured—so you can eliminate duplication, reduce errors, and ensure your teams always work from the latest approved file.

Key Benefits:

• Upload, categorize, and manage documents with approval controls
• Version control with automatic tracking and expiration alerts
• Link documents to suppliers, processes, or assets
• Restrict access by role or department for tighter control
• Search and retrieve documentation instantly during audits

Keep everything in sync—and in spec.
V5 gives your QA and operations teams one secure place to manage documentation, avoiding version drift and compliance gaps. It’s document control without the busywork.

Deeper? let’s get into it!!

???? Document Control Repository
This screen showcases the core document management functionality within V5. Users can define document types, upload controlled files, assign approval workflows, and track version history with precision. Whether it’s a monograph, ISO certificate, or supplier file, each document is versioned, status-flagged, and linked to specific workflow templates—making approvals, updates, and expirations fully auditable and traceable.

???? Document Supplier Link
This view focuses on supplier documentation management. Here, documents are directly assigned to specific suppliers, allowing QA teams to monitor expiration dates, versions, and approval status at a glance. With support for multiple document types—from Halal and Kosher certificates to FSCC and ingredient specs—V5 ensures your supplier compliance is airtight and always inspection-ready.

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.
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.

Keep every shift in compliance—live, on the line.
Real-time production checks are your first line of defense against non-conformances. V5’s Line Check module prompts operators with live Q&A, captures response data, and instantly escalates issues. From allergen controls to SPC entries, it keeps the production floor in spec without slowing it down.

Key Benefits:

• Build event-based checklists linked to specific commodities or workflows
• Configure preset responses with deviation logic and escalation paths
• Enable operators to confirm and document compliance live
• Automatically generate NCRs when thresholds are breached
• Seamlessly integrates with plant-floor systems and dashboards

When the line moves fast, compliance must move faster.
V5 ensures that quality checks aren’t skipped and issues are escalated as they happen. It’s your real-time safeguard against out-of-spec production.

Deeper? let’s get into it!!

????Line Check Configuration & Escalation Setup
This screen shows how V5 allows you to configure real-time line checks across any stage of production. Each question is assigned to a specific process group and linked to a commodity, location, and expected specification. Responses are severity-rated with logic to trigger event notes, escalate to specific users or groups, and generate NCRs automatically (please note – escalation, deviation & NCR generation requires the Enterprise Tier). Whether verifying cleanroom compliance or validating raw material handling, V5 ensures critical checks are enforced and instantly actionable.

????Operator Execution & Safety Alerts
The second set of screens highlights how operators interact with line checks on the floor. Users are prompted with visual specifications and predefined responses, making it easy to complete compliance steps accurately under pressure. When issues are detected—like damaged labels or allergen risks—the system delivers clear alerts, auto-generates corrective workflows, and prevents batch progression until resolved. This is frontline quality control, fully digitized and built for regulatory speed.

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.

Digitize every sign-off, without bottlenecks.
Manual approvals cause delays, missed escalations, and audit chaos. V5 streamlines sign-offs with configurable approval workflows, automated reminders, and full traceability. Whether it’s a document, SOP, or quality report, approvals happen fast, track cleanly, and leave zero gaps.

Key Benefits:

• Build approval workflows with escalation timers and decision logic
• Assign by user, department, or role with digital signatures
• Monitor approval progress and status from a central dashboard
• Archive every decision with full traceability for audits
• Speed up document control, CAPA resolution, and training release

Approvals don’t need to be paper-based or people-blocked.
V5 puts structure and speed into your sign-off process so compliance can keep pace with production.

Deeper? let’s get into it!!

✅Real-Time Approval Tracking
This first screen demonstrates how V5 manages real-time digital approvals across formulas, AWCs, batches, and documents. Each approval request moves through clearly defined stages, assigned by role and trackable by user. Time limits and escalation paths keep workflows on schedule, while full audit logs ensure every decision—whether pending or approved—is documented for regulatory compliance.

✅Custom Workflow Templates
The second screen shows how approval workflows are standardized using customizable templates. From raw material specs to supplier qualifications and product release forms, each template defines the necessary stages, roles, and review timeframes. V5 empowers quality teams to build reusable, role-specific approval chains that eliminate bottlenecks and keep compliance-controlled processes moving at the speed of production.

Lab testing done right, right from the start.
V5’s LIMS module gives you full control over your lab processes—from test creation to sample scheduling and results logging. It supports everything from raw material sampling to finished goods testing, while managing reagents, supplies, and documentation in one place.

Key Benefits:

• Create Analytical Work Cards (AWCs) with test limits and controls
• Schedule and track sampling by material, batch, or workflow stage
• Manage lab inventory including reagents and materials
• Generate labels, monitor test status, and trigger escalations
• Link lab results directly to quality events or product records

Less admin. More analysis. Total control.
Whether you’re running an in-house lab or coordinating external testing, V5 gives you the infrastructure to stay compliant, efficient, and error-free.

Deeper? let’s get into it!!

????Analytical Work Card Management
This screen shows the setup and management of Analytical Work Cards (AWCs) in V5. Each AWC defines the specific lab tests to be performed on a product or batch, with parameters like dosage form, regulatory standard, method references, and acceptance limits. Built-in severity levels and instructions ensure every test—whether for assay, pH, or microbiological limits—is fully controlled and compliant from start to finish.

????Lab Material Inventory
The second screen highlights V5’s Lab Materials inventory control, tracking everything from volumetric flasks to reagent lots. Each item includes supplier data, expiry dates, stock levels, and assigned storage locations. With automated lot labeling and full traceability, your lab stays stocked, compliant, and audit-ready—down to the milligram.

????AWC Job Scheduling & Assignment
This screen presents how lab testing jobs are scheduled and assigned. Specific batches and sample counts are tied to AWCs, and individual tests are distributed across lab users with clear due dates. It’s a structured, traceable approach to workload management that keeps quality labs moving efficiently while maintaining full documentation.

????In-Lab Execution & Results Entry
The final screen captures how technicians interact with test data entry. Results are entered against defined limits, with automatic flagging of deviations and visual grouping by test type. Whether it’s HPLC, stability, or identification testing, V5 guides lab users through procedures and ensures every value is compliant, complete, and recorded in real time.

End-to-end visibility on every piece of equipment.
Compliance doesn’t stop at people and processes—your equipment matters too. V5’s Asset module tracks every calibration, maintenance task, and usage event. From installation to retirement, each asset has a full digital history tied directly to your manufacturing workflows.

Key Benefits:

• Create asset libraries with calibration schedules and maintenance tasks
• Assign equipment to specific products, stages, or batches
• Manage parts inventory and task execution from a central dashboard
• Capture deviations and escalate maintenance failures
• Link to SOPs, quality events, and LIMS for complete lifecycle tracking

Your assets are critical. V5 treats them that way.
Instead of chasing clipboards or outdated spreadsheets, you get one system that keeps every asset compliant, operational, and always ready.

Deeper? let’s get into it!!

????️Asset Registry & Task Management
This screen shows the foundation of V5’s asset tracking system. Each piece of equipment—from HPLCs to mixers—is logged with full metadata, including manufacturer, model, calibration schedules, and in-service dates. Beneath that, you’ll find linked asset tasks like inspections, maintenance, or calibration—each with assigned responsibility. It’s end-to-end traceability that ensures your critical assets are always compliant and production-ready.

????️Formula-to-Asset Linking
Here, V5 bridges the gap between production formulas and the equipment used to execute them. Products and batches are linked to the exact machines required to run them—ensuring traceability, repeatability, and regulatory alignment. When assets are pre-assigned to formulations, validations, maintenance logs, and production performance all fall neatly into place.

????️Task Scheduling & Execution Readiness
This screen covers the asset task scheduler. Tasks like calibration checks and firmware updates are assigned due dates, tracked by status, and escalated if missed. With real-time visibility, maintenance managers can see what’s scheduled, what’s complete, and what’s overdue—ensuring zero downtime surprises and full GMP alignment.

????️Operator Interaction & Substitution Controls
This set of screens shows how operators confirm or substitute assets during live operations. Users verify the correct equipment is in use, record inspection results, and escalate failures (like a worn seal or out-of-calibration reading) directly to QA or maintenance. With picture prompts, structured checklists, and deviation routing, V5 transforms asset control into an active quality checkpoint.

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.