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.

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

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.

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. 

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.

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

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.

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.

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 location
• Global accessibility

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

1. Web Purchase: Our on-premise solution, where QT9 ERP is installed locally on the client’s web server.
2. Web Subscription: Cloud-based ERP subscription hosted on QT9’s servers and access via the internet and a web browser.

QT9 offers award-winning support services, including:

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

Pharmaceutical manufacturers need an ERP that does more than manage production, it must help meet compliance, reduce risk and scale operations. QT9 ERP offers unmatched capabilities for regulated pharma environments.

• Designed for pharmaceutical batch production, including eDHR/eDMR  

• Supports end-to-end supply chain visibility

• 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