Massimo Crudeli Massimo Crudeli
Jan 12, 2023 9:00:00 AM

 

An integrated ERP system covers every aspect of your pharmaceutical manufacturing business, from procurement and production scheduling to supply chain management, quality assurance, warehousing, and sales.  

You are here on this page because you are looking for the best ERP for pharmaceuticals. If you are here, then you must be going through any of the following challenges with your current ERP system: 

  • You are using an outdated or legacy system that's unsupported, slowing up your processes and affecting the quality of your products
  • You are using multiple systems that are highly complex to maintain and use. The different departments and processes in your organization do not have a single view of the data flow in your value chain leading to silos, duplicate efforts, and slow production.
  • You want to scale your operations and upgrade to a modern and advanced ERP system that will give you an edge in the market. 

There are many ERP systems you will find in the market and big names that people trust and respect like Microsoft, SAP, and ORACLE NetSuite. These are all compelling solutions and brands with years of experience and are used by various companies across the globe. 

As mentioned, these are tried-and-tested ERP solutions, but what's worth noting is that they're not designed specifically for life sciences companies. While they offer general capabilities that can serve any industry, they fall short when it comes to the unique needs of pharmaceutical businesses.  

Pharmaceutical companies like yours require specialized features like quality management, weighing and dispensing, supply chain management, and compliance support. General ERPs often miss the mark on critical compliance needs, such as electronic signatures, second-person verification, and batch-level traceability. These are essential to meeting the quality and compliance standards specific to life sciences organizations. 

What kind of ERP should a pharma organization choose?  

The ideal solution combines the power of proven platforms like Microsoft Dynamics 365 F&SCM with specialized capabilities tailored to the life sciences industry—think quality management, validation, weighing & dispensing, supply chain management, and more—all within one unified system. 

This integrated system covers every aspect of your pharmaceutical manufacturing business, from procurement and production scheduling to supply chain management, quality assurance, warehousing, and sales.  

With a cloud-native Microsoft Dynamics platform and life sciences-specific features, you'll enjoy seamless operations and eliminate the complexity and costs of managing multiple systems.  

With a single, unified solution, you get the best of both worlds― the robust capabilities of the Microsoft Dynamics platform combined with the specialized solutions your business needs. 

Key features every integrated ERP for pharmaceuticals should have:   

1. Supply Chain Management: Pharma companies manage intricate supply chains, where precision and efficiency are non-negotiable. With their products directly affecting patient health, operations must run seamlessly while adhering to strict regulatory standards.  

Every detail matters, from sourcing high-quality materials from trusted suppliers to ensuring precise quantities. Even the slightest deviation can compromise product safety and effectiveness. 

To succeed, these companies need end-to-end visibility across their supply chains and seamless collaboration with stakeholders. 

2. Warehouse Management: Pharmaceutical companies need an effective warehouse management system to ensure compliance with stringent regulations, accurate inventory tracking, and guarantee product safety. A unified ERP for pharmaceuticals enables real-time visibility into inventory, proper storage conditions, and seamless monitoring of batches and expiration dates. It minimizes errors, reduces waste, and ensures timely delivery of products—all critical for meeting regulatory standards, protecting patient safety, and optimizing operational efficiency. 

 3. LIMS/Quality Management: A quality management software integrated with an ERP system streamlines processes, improves coordination, and boosts data transparency. By reducing manual errors and ensuring data integrity, it creates a single source of truth, enhancing security and ensuring greater accuracy, compliance, and transparency. 

 4. Clinical Trials/Supplies Management: Efficient clinical supply management depends on clear visibility across the supply chain, covering everything from data management and demand forecasting to packaging and distribution. A unified ERP system provides this visibility, delivering a 360-degree view of operations while accurately handling logistics, scheduling, and budgeting to meet market demands. It ensures precise forecasting and demand planning, enables full material traceability across the supply chain, and supports compliance with regulations like FDA 21 CFR Part 11 and EU GMP Annex 11. 

 5. Weighing & Dispensing: Accurate and precise weighing and dispensing of ingredients is critical for pharmaceutical manufacturing. Precision in this process ensures that finished products meet all specifications, as the components used in production must strictly match the approved formula. 

Beyond accuracy, the process must guarantee compliance with GMP standards—only approved batches should be weighed using the correct scales and handled according to established parameters. 

Pharmaceutical companies are turning to computerized systems for greater precision and automated control in weighing and dispensing. These systems use electronic scales, barcode scanners, and advanced software to streamline the process, delivering accuracy and control over manufacturing operations. 

When integrated into an ERP system, weighing and dispensing software goes beyond improving quality control. It enhances productivity, reduces operational costs, minimizes expensive rework, and boosts throughput. A fully integrated solution not only keeps pace with rapidly evolving regulations but also eliminates manual data entry. Operators no longer need to log dispensing operations into the ERP. 

6. Data Security: For a pharmaceutical company, managing data security is critical to ensure compliance with stringent regulations like GxP, GDPR, and SoX, which govern data integrity, privacy, and security. A unified ERP system with data security features helps streamline the configuration of roles, permissions, and privileges, making it easier to maintain secure data, track changes, and safeguard roles across environments. This not only protects sensitive information but also simplifies the validation process, reduces the risk of non-compliance, and ensures operational efficiency—all while maintaining the highest standards of data protection and regulatory adherence. 

7. Data Integration Capabilities: In pharmaceutical manufacturing, departments must work together smoothly. Many pharma manufacturers use a mix of separate systems like LIMS, weighing and dispensing software, and ERP. While these solutions are helpful, using them separately can lead to complexities.   

When systems don't connect, it's harder to document processes correctly, track audit trails, and produce accurate reports—leading to regulatory issues, fines, and delays. Integrating data helps ensure traceability, especially when working with contract manufacturers, making operations smoother, more compliant, and more efficient. 

Like any large organization, multinational pharmaceutical manufacturers require an enterprise ERP system to automate and optimize key business processes. Additionally, they need an ERP system that supports compliance with critical regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, and GxP. 

Here are some features to look for when evaluating ERP for pharmaceuticals: 

  • Demand planning and forecasting 
  • Ability to add approved vendors and manufacturers 
  • Ability to add vendor and manufacturer qualification status 
  • Creating and automating quality orders 
  • Comprehensive inventory management system for multiple sites and warehouses, with real-time information on inventory movement
  • Advanced label printing 
  • Pack and containerization 
  • Transportation management 
  • Ability to interface with third-party logistics for transportation needs
  • Automated sales workflows    
To explore the features the best ERP system in the pharmaceutical industry should provide, download the Pharma ERP checklist.

Configuration over Customization 

At STAEDEAN, we're dedicated to helping pharmaceutical companies and other life sciences organizations adapt Microsoft's premier ERP system for industry-specific functionality. 

STAEDEAN Life Sciences is a commercial off-the-shelf (COTS) solution designed for pharmaceutical, biotech, and clinical supply companies at both mid-market and enterprise levels. It supports FDA 21 CFR Part 11, EU GMP Annex 11, and GxP compliance out of the box. Since it's a COTS solution, it requires minimal customization, resulting in easier integration and reduced validation efforts. 

The powerful GAMP 5 Category 4 (configurable) solution delivers the industry-specific modules that life sciences firms need across five key areas:  

  • Supply Chain Management
  • Warehouse Management​
  • Clinical Trials/Supplies Management​
  • Security & Compliance Management​
  • DataIntegration Capabilities

In addition to the above capabilities, STAEDEAN also offers the following features for those looking to strengthen their ERP for pharmaceuticals further: 

  • Quality Management System/Laboratory Information Management System (LIMS) 
  • Weighing & Dispensing​ (W&D)  
  • Validation Toolkit 
  • EDI 
  • Project Control and Management 
  • Data Governance 

Engineered for manufacturing, packaging, and distribution business models, STAEDEAN Life Sciences simplifies operations with a simple, integrated technology stack.  

STAEDEAN-Life-Sciences (3)

As STAEDEAN Life Sciences is seamlessly embedded within the cloud-native Microsoft Dynamics 365 F&SCM, users can take advantage of the collective strengths of both solutions. It combines the powerful standard features of Microsoft Dynamics, including Copilot and cloud capabilities, with STAEDEAN's industry-specific enhancements. The result? A unified, all-in-one solution to help meet the life sciences industry's unique needs.  

Key features include, among  others: 

  • Electronic signatures that complies with FDA 21 CFR Part 11
  • Track & trace inventory on sub-batch/sub-lot level
  • Real-time inventory updates via scales that can be integrated with ERP for Weighing & Dispensing
  • Mobile app for advanced warehouse management 

 

Massimo Crudeli

Massimo Crudeli

Director, Client Solutions

TI_LOGO_TI-Logo-color andAXP_365

have now rebranded to

staedean-logo-teal