ERP

QT9 ERP by QT9 Software is a cloud-based, on-premise, or hybrid Enterprise Resource Planning platform purpose-built for regulated manufacturers. Ranked by Forbes as the number one ERP platform for life sciences companies, it is designed to connect operations, quality, and compliance in a single, pre-validated system. QT9 ERP is especially well-suited for organizations in medical devices, pharmaceuticals, aerospace and defense, automotive, and general manufacturing — any industry where audit-ready traceability, FDA and ISO compliance, and operational control are non-negotiable.

At its core, QT9 ERP eliminates the need for disconnected systems by bringing production, inventory, purchasing, supply chain, sales, financials, and compliance portals together in one integrated platform. Embedded automation workflows reduce manual, time-consuming processes, minimize human error, and deliver real-time insights that accelerate decision-making. The platform is designed to go live in months rather than years, supported by US-based expert onboarding and guided implementation.

Core Manufacturing and Operations Modules

• MRP Planning: Automatically generate work orders and purchase orders based on real-time demand signals.
• Job Management: Schedule jobs, assign tasks, and monitor production progress on the shop floor in real time.
• Bill of Materials: Manage multi-level BOMs to support complex assemblies and multi-stage production.
• Shop Floor Management: Control and track production activities directly from the shop floor.
• Rework Management: Handle rework processes within the same integrated environment.
• Inventory Management: Track inventory levels, movements, and locations with full lot control and traceability.
• Purchasing Automation: Create and manage purchase orders, supplier data, and receipts in one place.
• Shipping and Receiving: Manage shipments, print labels, and log receipts to keep logistics on track.
• Invoicing and Billing: Generate, send, and track invoices with built-in status monitoring.
• Customer Management: Track customer interactions, sales history, and communications in a single view.
• Supplier Management: Manage supplier records, contacts, and performance with a full audit history.
• Custom Reporting: Generate reports using live ERP data and export to Excel or BI tools, with real-time dashboards and built-in analytics.

Pre-Validated Compliance and Regulatory Features

• QT9 ERP ships pre-validated, covering FDA and ISO compliance out of the box — eliminating the need for costly internal validation efforts or consultant fees.
• Includes complete execution of Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols.
• Supports a broad range of compliance standards including ISO 9001, ISO 13485, ISO 14001, ISO 17025, AS9100/IA9100, MoCRA, FDA 21 CFR Part 11, FDA 21 CFR Part 210/211, QMSR (FDA 21 CFR Part 820), EU GMP, EU MDR, and GxP Compliance.
• Electronic signature approvals and secure access controls are built in, supporting 21 CFR Part 11 requirements.
• Continuous validation and updates ensure the platform remains audit-ready as regulations evolve.
• Reduces downtime waiting for ERP approval and minimizes the risk of failed audits due to flawed validation protocols.

End-to-End Traceability and Audit Readiness

• Full forward and backward traceability across raw materials, inventory movements, production history, and finished goods.
• Tracks every part, product, and process in real time — from purchase order through shipment — across the entire supply chain.
• Enables quick product recalls and simplified audits in compliance with ISO 9001 and FDA 21 CFR regulations.
• Drives accountability at every stage of production with a transparent, auditable data trail from design through delivery.

ERP Compliance Portal and Electronic Records

• Digitizes Device History Records (DHR/MDR) and Batch Records (MBR/EBR) in one secure, centralized system.
• Authorized auditors, inspectors, or compliance officers can securely log in to view or print compliance data — including MDR, DHR, MBR, and EBR — without accessing unrelated ERP modules, minimizing compliance risk and safeguarding sensitive operational data.
• One-click record generation automatically compiles BOMs, routings, QMS documents, inspection data, job travelers, and approvals into a single validated report, eliminating manual data collection.
• Supports single-level and multi-level record generation for complex assemblies or multi-stage production processes.
• Helps manufacturers comply with FDA 21 CFR Part 210/211/820, ISO 13485, and GMP requirements with a transparent, auditable trail.

Native QMS Integration and Issue Management

• QT9 ERP integrates natively with QT9 QMS, enabling seamless, real-time data flow between operations and quality without third-party integrations.
• Provides immediate visibility into nonconformances, CAPAs, and inspections tied directly to jobs and materials.
• Ensures MDR/DHR and MBR/EBR records always reflect the latest approved documents, inspection plans, and production data.
• Guarantees only current revisions of controlled documents are included, maintaining full traceability and compliance.
• Enables early identification of issues to minimize impact, prevent defects, reduce downtime, and lower compliance risks.

Customer, Supplier, and Compliance Portals

• Dedicated web portals for customers, suppliers, and compliance stakeholders ensure secure access to vital documents.
• Improves communication and collaboration across the supply chain and with regulatory bodies.
• Multi-site capability allows data sharing across various sites and functions from a single centralized platform.

QT9 ERP is available as a cloud, on-premise, or hybrid deployment to match any IT strategy without compromising security or speed. All modules are included in the platform, allowing organizations to scale usage as business needs grow. With US-based support, guided onboarding, and a user-friendly interface designed to reduce the learning curve for teams of all sizes — from startups to enterprises — QT9 ERP is a comprehensive, scalable solution for regulated manufacturers seeking operational control and compliance confidence.