PHARMACEUTICAL ERP SOFTWARE

ERP for pharmaceutical companies

QT9™ ERP is ideally set up for FDA 21 CFR Part 210 and FDA 21 CFR Part 211 compliance, including FDA 21 CFR Part 11 electronic signatures. QT9 ERP is an intuitive platform with one-click Master Batch Record (MBR) and Electronic Batch Record (EBR) capability, record traceability and inventory control with barcoding for the pharmaceutical industry.

ERP for pharmaceutical companies | QT9 ERP
PHARMACEUTICAL ERP VALIDATION

Validation made easy

Need to validate your ERP solution? QT9 ERP handles your validation for you - saving you precious time and money. Get a quote or sign up for a live demo today.

FLEXIBLE PHARMACEUTICAL ERP

Why QT9 ERP for pharmaceutical companies?

  • QT9 ERP is fully-validated with IQ, OQ, PQ validation reports included for free for every version upgrade.

  • Our ERP includes complete approval processes for batch records, sales orders, purchase orders and jobs.

  • We help you control the release of inventory through electronic approval processes.

  • With QT9 ERP, you can verify steps in your manufacturing processes using electronic signature approvals.

  • Integrate Bill of Materials and Jobs with controlled documents from QT9 QMS.

  • Integrate purchasing and manufacturing with electronic inspections in QT9 QMS.

  • Incorporate unlimited file attachments to compliance records - including EBRs.

ERP for pharma companies | QT9 ERP
PHARMACEUTICAL ERP FUNCTIONS

Connect every team in your pharmaceutical business

Get better Bill of Materials management, automatic inventory alerts and seamless links to robust quality management software.

MBR and EBR Capability

  • One-click print MBR and EBR

  • Compliance Portal for auditors

  • Eliminate paper processes

Automate Compliance

Control Inventory

  • Expiring inventory alerts

  • Lot and serial traceability

  • Barcode inventory for accuracy

Improve Operations

  • Bill of Material revision control

  • Visual production scheduling

  • Shop floor management

Reporting & Analytics

  • Filter, summarize and export data

  • Performance dashboards

  • Custom reporting

Purchasing & Planning

  • Reorder points and lead times

  • MRP and forecasting capability

  • PO inspections and approvals

QT9 ERP seamlessly integrates with QT9's quality management software suite

Automatically sync your suppliers, customers, and products across QT9 ERP and QT9 QMS and experience a unified system for managing quality and business operations.

Non-Conformance & CAPA Management

ERP Quality CAPAs | QT9 ERP

Non-conformance and CAPA management

Nonconforming product records and corrective actions can be created in QT9 QMS right from event-driven actions in QT9 ERP.  These include PO receiving, inspection and history, as well as from the Jobs/Manufacturing and customer sales and service areas.  By giving users the ability to create non-conformance and CAPA records from the ERP, there is full data transfer and permanent linking to your QMS records in the ERP, saving time and maintaining historical data about quality actions in your ERP. 

Supplier & Vendor Management

ERP Quality Supplier Management | QT9 ERP

Supplier and vendor management

QT9 ERP maintains supplier records, while QT9 QMS tracks supplier quality performance and audits. Supplier-related nonconformances, engineering changes, audits and other quality processes in QT9 QMS sync with vendor records in QT9 ERP to ensure compliance.

Document Control & Revision Management

ERP Quality Document Control | QT9 ERP

Document control and revision management

QT9 QMS document control links with QT9 ERP to ensure only approved, up-to-date documents (e.g., SOPs, work instructions) are accessible for production, engineering and quality teams.

QT9 QMS documents can be approved as part of QT9 ERP Bill of Materials and enable seamless passthrough to the Shop Floor Manager. This gives production-floor employees access to the latest approved work instructions and other controlled documents.

Production & Purchasing Inspections

ERP Quality Purchasing and Inspections | QT9 ERP

Production and purchasing inspections

Work orders and production processes in QT9 ERP can create quality inspections in QT9 QMS, transferring the proper manufacturing data to the inspection record.

PO receiving can generate the proper QT9 QMS inspection record for your supplier and material-specific inspections.

Customer Complaints & Returns (RMA Process)

ERP-Quality-Complaints | QT9 ERP

Customer complaints and returns (RMA process)

Customer returns in QT9 ERP have the ability to generate customer complaints and feedback records in QT9 QMS, creating a seamless customer service and quality experience.

Root cause analysis in QT9 QMS feeds into ERP adjustments for inventory, production and supplier performance.

ERP Quality CAPAs | QT9 ERP

Non-conformance and CAPA management

Nonconforming product records and corrective actions can be created in QT9 QMS right from event-driven actions in QT9 ERP.  These include PO receiving, inspection and history, as well as from the Jobs/Manufacturing and customer sales and service areas.  By giving users the ability to create non-conformance and CAPA records from the ERP, there is full data transfer and permanent linking to your QMS records in the ERP, saving time and maintaining historical data about quality actions in your ERP. 

ERP Quality Supplier Management | QT9 ERP

Supplier and vendor management

QT9 ERP maintains supplier records, while QT9 QMS tracks supplier quality performance and audits. Supplier-related nonconformances, engineering changes, audits and other quality processes in QT9 QMS sync with vendor records in QT9 ERP to ensure compliance.

ERP Quality Document Control | QT9 ERP

Document control and revision management

QT9 QMS document control links with QT9 ERP to ensure only approved, up-to-date documents (e.g., SOPs, work instructions) are accessible for production, engineering and quality teams.

QT9 QMS documents can be approved as part of QT9 ERP Bill of Materials and enable seamless passthrough to the Shop Floor Manager. This gives production-floor employees access to the latest approved work instructions and other controlled documents.

ERP Quality Purchasing and Inspections | QT9 ERP

Production and purchasing inspections

Work orders and production processes in QT9 ERP can create quality inspections in QT9 QMS, transferring the proper manufacturing data to the inspection record.

PO receiving can generate the proper QT9 QMS inspection record for your supplier and material-specific inspections.

ERP-Quality-Complaints | QT9 ERP

Customer complaints and returns (RMA process)

Customer returns in QT9 ERP have the ability to generate customer complaints and feedback records in QT9 QMS, creating a seamless customer service and quality experience.

Root cause analysis in QT9 QMS feeds into ERP adjustments for inventory, production and supplier performance.

PHARMACEUTICAL TRACEABILITY

ERP for pharmaceutical companies, designed to simplify traceability

Streamline how pharmaceutical manufacturers share, access and collaborate across roles, departments and locations. QT9 ERP for pharmaceutical companies provides a central place to see who worked on what, when, with FDA 21 Part 11 electronic signature approvals and transactional audit trails.

Pharmaceutical ERP Software Traceability | QT9 ERP
Digitize Pharmaceutical ERP Software | QT9 ERP
PHARMACEUTICAL QUALITY

Digitize pharmaceutical quality workflows

Don't waste effort on time-consuming, redundant tasks. No matter where your team works, QT9 ERP automates tasks so you can deliver high-quality, safe products consistent with Good Manufacturing Practices (GMP). Integration with our industry-leading Quality Management Software (QT9 QMS) gives you one, single platform for your pharmaceutical manufacturing business.

PHARMACEUTICAL RECALLS

Protect against recalls

QT9's ERP for pharamceutical companies helps minimize risk by enabling you to control every revision of your Bill of Materials, so you know who ordered what, when it was manufactured and exactly what materials went into it. Find recall information in seconds rather than days.

Pharmaceutical ERP Software for Manufacturing | QT9 ERP
PHARMACEUTICAL ERP INTEGRATION

Centralize all your operations in one place

Connect data across business operations to reduce data silos. QT9 ERP integrates data to help you see everything in one place.

NEED CLARIFICATION?

Pharmaceutical ERP FAQs

What is pharmaceutical ERP software?

Pharmaceutical ERP software is an Enterprise Resource Planning (ERP) system specifically designed for pharmaceutical manufacturers. It integrates and manages all core business processes, including inventory control, production, suppliers, purchasing and sales, all within a single platform. Many pharmaceutical ERP systems are also able to monitor and manage quality, safety and compliance in support of adherence to government regulations and standards.

What are the key features of pharmaceutical ERP software?

Pharmaceutical manufacturers need an ERP system that goes beyond standard ERP functions to include automations that optimize industry-specific tasks, such as batch and formula management, and that supports GxP and 21 CFR Part 11 compliance.

While a standard ERP generally offers accounting, sales, procurement and basic manufacturing applications, pharmaceutical ERP software also offers additional features, such as: 

  • Electronic batch records 
  • Batch/lot tracking
  • Lot and serial traceability 
  • Supplier management 
  • Advanced inventory management 
  • Compliance management 
  • Reporting and analytics 
  • Quality management
  • Validated platform

How does ERP software help with pharmaceutical regulatory compliance?

Traceability is a cornerstone of pharmaceutical regulatory compliance. ERP software provides a built-in audit trail by digitally capturing materials and production data, often in real time. This data can be used for regulatory reporting as well as forecasting and analytics. A compliant ERP should support FDA 21 CFR Part 11, GAMP 5 guidelines, GMP, EMA, MHRA and WHO regulations. 

QT9 ERP offers electronic device records (eBRs and eMBRs), barcoding, and lot and serial tracking, which supports the ability to locate product or materials in the event of a recall in compliance with regulatory mandates. What’s more, QT9 ERP seamlessly integrates with QT9 QMS quality management software, which provides more specific regulatory applications, such as document control and corrective and preventive actions (CAPA) management.

How much does an ERP system cost?

ERP costs vary depending on the size of your business, specific needs and platform required. There are a wide variety of pricing packages available from ERP software vendors as well. Important factors to be aware of include: 

  • Cloud-based vs. on-premise: Cloud-based ERP delivery is generally more affordable and eliminates the need for dedicated on-site resources. QT9 offers both options. 
  • Licensing structure: There are a variety of licensing models used by ERP software vendors. Be sure you know how many users are covered by a license and what type of access. Some vendors offer read-only access at a discount.  
  • Additional fees: Be sure you ask about any other extra costs, such as for training, implementation or data transfer. 

Is the QT9 ERP system validated or does it support validation?

Yes, QT9 ERP is fully validated and provides free continuous validation. This means that QT9 ERP has already rigorously tested and documented that our ERP performs as intended and meets FDA 21 CFR Part 11, Part 211 and Part 820 regulatory requirements, and is ISO 9001 and ISO 27001 certified.

How does the ERP support risk management and traceability?

QT9 ERP software supports risk management and traceability through an integrated suite of tools designed to streamline and integrate processes and data accuracy, and enhance visibility across operations. More specifically, QT9 ERP offers:

  • Batch, lot and serial number tracking
  • Integrated inventory control
  • Supplier management applications
  • End-to-end traceability
  • Seamless integration with QT9 QMS software

What are QT9 ERP's integration capabilities?

In addition to full integration between business processes through its applications, QT9 ERP offers seamless integration with QT9 QMS quality management software, which offers end-to-end regulatory and quality compliance tools, such as document control and CAPA management.

QT9 ERP also offers easy integration of its Business Intelligence tool, which provides advanced analytic capabilities that help manufacturers identify trends and optimize performance.

Can QT9 ERP handle multi-site, multi-country operations?

Yes, QT9 ERP provides a multi-site, multi-company architecture designed to connect data, users and operations across locations, departments or companies. Manage global initiatives from anywhere and be more productive and consistent across operations.

Is QT9 ERP scalable?

QT9 ERP is highly scalable, designed to easily grow with your business’ needs, whether they be growth, expansion or increased data volume. Our cloud-based architecture offers:

  • Unlimited data
  • 17+ integrated applications
  • Ability to adopt applications as needed
  • Easy addition of more users and locations
  • Global accessibility

Is QT9 ERP available in the cloud or on-premise?

Both! QT9 ERP offers both on-premise and cloud-based solutions. Customers can choose the platform that works best from them from three options:

  1. Desktop Cloud: QT9 ERP is installed on the client’s Windows PC with an internet connection to their data.
  2. Web Purchase: Our on-premise solution, where QT9 ERP is installed locally on the client’s web server.
  3. Web Subscription: This is a cloud-based ERP subscription hosted on QT9’s servers and accessed via the internet and a web browser.

What type of training and support is included?

QT9 offers award-winning support services, including:

  • Unlimited training, from onboarding to refreshers
  • Unlimited support, including implementation and software optimization
  • QT9 ERP Help Center, self-service support available 24/7
  • Fully validated platform
  • Free software updates
  • Professional services for accounting and operations

Why choose QT9 ERP as your pharmaceutical software solution?

QT9 ERP is a comprehensive system that can work for any size company, improving efficiency and accuracy through integrated data and automated operations. 

QT9 ERP provides more than 17 modules as part of its standard offering, as well as easy access to data and analytics to help businesses make the best decisions for moving forward. 

With QT9 ERP you get: 

  • 17+ modules, including eDHR/eDMR  
  • Customer, compliance, supplier and physical inventory web portals 
  • Lot and serial number tracking  
  • Advanced inventory control 
  • Tailored customer support 
  • Real-time reporting with mobile accessibility 
  • Seamless integration with QT9 QMS quality and compliance software 

Reach out today for a demonstration or to get started with a free trial. 

Experience QT9 ERP in action today

Schedule your personalized demo and start a free trial.