Solve Pharma's Biggest Challenges with a Unified Dynamics 365 ERP for Life Sciences
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A patchwork of legacy systems, exacerbated by extensive merger and acquisition activities over the years, has exposed pharmaceutical, biotech, and clinical supplies companies to greater risk of regulatory consequences and increased operating costs.
For pharma and biotech manufacturing companies, the stakes are too high to rely on systems that don't connect. Without real-time visibility over inventory and production, decision-making becomes guesswork.
Reliance on manual processes only compounds the issue, driving up error and increasing the risk of compliance in an industry where accuracy is crucial. Add the ongoing headache of separate validations and maintenance for each application.
Modern solutions like Dynamics 365 for Life Sciences address these challenges by providing integrated and scalable technology tailored for the industry.
So, what are the biggest challenges facing pharma organizations with multiple legacy systems? Let's dive in.
Top 5 Pharma Challenges and How to Solve Them
Meeting strict regulatory standards with multiple systems while scaling isn't easy for pharma and life sciences companies. However, the right ERP system can make day-to-day processes seamless and efficient. So, what's the right ERP system?
A unified and comprehensive industry-specific ERP system that connects all departments.
Here are the top 5 challenges and how a unified solution tackles them:
1. Supply chain complexities: Pharma supply chains are a global maze—from sourcing to packaging, every step is critical. With temperature-sensitive materials, cold chain logistics, and varied regional regulations, even a small delay or compliance slip can disrupt production and impact patient access. Real-time visibility and modernization are key to keeping products moving reliably.
Solution: A single solution means all teams—from procurement to sales—are on the same page. This seamless flow of information improves supply chain visibility, ensuring the smooth manufacturing of high-quality products.
2. Regulatory compliance: Pharma and life sciences companies face relentless pressure to meet evolving regulatory standards like GxP, FDA, and GDPR. Strict controls on data, safety, and efficacy mean meticulous records and validated processes are non-negotiable. The cost of non-compliance? Penalties, recalls, and even market withdrawal. Staying proactive is essential to avoid costly disruptions and keep operations running smoothly.
Solution: With real-time data access and complete supply chain visibility, you can spot errors and discrepancies quickly. Capabilities like quality management and validation help generate and create accurate regulatory reports on time, ensuring compliance with standards like 21 CFR Part 11 (US) and EU GMP Annex 11 (EU).
3. Multiple, non-integrated applications: Many companies work with multiple, isolated systems for different functions (e.g., finance, weighing and dispensing, MES, and quality control). This fragmentation leads to data silos, duplications, and inconsistencies across departments, making it difficult to achieve an integrated view of operations. Non-integrated applications require manual data transfers and increase the risk of human errors. Lack of system integration also complicates cross-functional collaboration, slowing down the decision-making processes.
Solution: A unified ERP such as Dynamics 365 for Life Sciences replaces multiple systems by integrating seamlessly with external tools like weighing and dispensing, eliminating the need for separate solutions. This streamlines operations reduces maintenance costs, boosts efficiency, and removes data silos and duplicate work. With everything connected, teams from planning to sales can collaborate effortlessly and in real time.
4. Increasing costs of customization: Many pharma companies rely on customized legacy systems that were initially tailored to meet their operational and compliance needs. However, as technology advances, these systems become increasingly costly and complex to maintain. Customization may need frequent updates to keep up with new industry standards and business requirements, leading to rising IT costs.
Solution: Modern cloud-based solutions, built on platforms like Microsoft Dynamics, SAP, or ORACLE, minimize the need for extensive customization. Their integration with industry-specific solutions simplifies processes, reduces validation efforts, and lowers update costs, making a unified system a more efficient choice for businesses.
5. Inability to scale due to lack of centralized data: Data silos hinder the ability to get insights into performance, making it difficult to forecast demand accurately, optimize production, or improve efficiency across functions. The expansion of business demands a unified, centralized data system that enables real-time reporting and provides the transparency necessary to manage a growing, global operation effectively.
Solution: A single, integrated ERP system provides real-time visibility across your entire organization, enabling better demand forecasting, optimized production, and improved efficiency. It reduces errors, ensures quality, and meets regulatory standards, allowing your team to focus on innovation and driving growth.
Standard ERP Systems Won't Cut It: Industry-Specific ERP is the Key
Replacing outdated legacy systems with a single, unified ERP solution simplifies operations across divisions and locations, providing a consistent source of truth for your entire organization. A modern, cloud-based ERP, ideally hosted and managed by trusted providers like Microsoft, SAP, or ORACLE, is the answer.
While Microsoft, SAP, and Oracle offer robust ERP systems for general businesses, life sciences organizations require more specialized solutions. Life Sciences companies need an ERP tailored to their industry, with built-in capabilities to automate complex processes and ensure regulatory compliance.
From Forecasting to Fulfillment: How STAEDEAN Life Sciences Streamlines Every Stage of a Pharma Product's Journey
With over 15 years of experience delivering solutions for pharma and life sciences, including multiple cloud migrations and GAMP5 (category 4) validations, we at STAEDEAN understand that a unified ERP is essential for operational efficiency. That's why we've developed STAEDEAN Life Sciences, a comprehensive solution fully embedded in Microsoft Dynamics 365 Finance and Supply Chain Management (F&SCM.)
It integrates seamlessly with Dynamics 365 for life sciences, enhancing its core ERP features with industry-specific capabilities. This powerful combination streamlines every stage of a pharma product's journey—from forecasting to fulfillment—covering everything from finance and CRM to production, procurement, and compliance.
The Dynamics 365 ERP for life sciences also meets the unique needs of the industry, managing everything from raw material procurement and supply chain to production, quality management, and warehousing. At the same time, Microsoft Dynamics 365 covers everything else to keep the process running smoothly.
Read STAEDEAN Life Sciences Solution Brochure for more information. |
STAEDEAN Life Sciences: Pack the power of Microsoft and Pharma Capabilities in One Solution
As STAEDEAN Life Sciences is fully embedded in Microsoft Dynamics 365 F&SCM, users can harness the power of Microsoft's advanced features while using life sciences-specific capabilities. By taking advantage of continuous updates, global compliance capabilities, easy scalability, and the power of Azure and AI, the unified Dynamics 365 for life sciences helps your business stay agile, secure, and ready for the future. Here's how you can maximize the benefits of Microsoft:
1. Continuous Updates: STAEDEAN Life Sciences is regularly updated in line with Microsoft's release schedule, ensuring your system is always running the latest version while keeping customer data secure.
2. Maximize Cloud Potential: Leverage the full capabilities of Azure without extra subscription costs. Dynamics 365 is a complete cloud solution hosted in Azure, and STAEDEAN Life Sciences users benefit from this integration.
3. Harness AI with Microsoft Copilot: Take advantage of AI-powered insights with Microsoft Copilot, optimizing decision-making and streamlining operations.
4. Global Compliance Made Easy: With Microsoft Dynamics, compliance is simplified, covering regulations in over 43 countries and supporting 48 languages.
5. Effortless Scaling: STADEAN Life Sciences integrates seamlessly with Dynamics 365, allowing you to easily add additional features like Microsoft Power Apps, whether it's a life sciences solution or a custom app.
Benefits of STAEDEAN Life Sciences Solution
1. Enhance supply chain visibility: The supply chain management feature in STAEDEAN Life Sciences solution lets you trace inventory at both the batch and sub-batch levels, ensuring precise tracking for items requiring deeper traceability. This enhanced control improves decision-making and ensures accurate reporting. As it is embedded in Microsoft Dynamics 365 F&SCM, you get a complete overview of data from finance, production planning, and scheduling to production, warehousing, and sales, providing you complete visibility into every aspect of your business.
2. Get compliance support: STAEDEAN Life Sciences supports your compliance efforts with regulations like 21 CFR Past 11 (US), EU GMP Annex 11 (EU). With robust testing, detailed reporting, and audit support, you can minimize non-compliance risks and respond to audits more efficiently.
3. Reduce validation effort: STAEDEAN's ERP Validation Toolkit offers a set of templates and sample documents that support you through the validation process focusing on medium and high-risk features and business processes. The toolkit supports you in the deployment of the STAEDEAN Life Sciences solution and helps validate your system, cutting your validation efforts by up to 25%.
4. Improve efficiency with integrated weighing & dispensing: STAEDEAN Life Sciences Weighing and Dispensing solution allows you to instantly update inventory based on weighed quantities, ensuring accurate inventory management. It seamlessly integrates with barcode scanners, labelling technology, and digital scales to deliver the right material to manufacturers on time, in the correct quantity, and with the right packaging and labelling. Integration with weighing and dispensing scales helps you simplify and automate critical processes for improved efficiency.
5. Elevate quality of processes and products: With industry-specific features, like flexible reduced testing, vendor-specific testing, stability studies, and role-controlled disposition codes, tailored specifically for life sciences companies, you can improve quality processes and ultimately produce quality products.
6. Track multiple projects with ease: STAEDEAN's project control suite helps life sciences companies, like CDMOs, easily track inventory and costs for each project, ensuring accurate resource management across multiple projects.
7. Eliminate silos with seamless data integration: Get real-time insights across operations with integrated data, eliminating silos and driving smarter decisions. Easily integrate with Laboratory Information Management and Weighing & Dispiensing systems. Gain the benefits of data capabilities to ensure seamless data integration and robust data security and governance.
8. Cut costs with a unified Dynamics 365 ERP: Multiple systems mean integrating data and maintaining numerous software solutions. STAEDEAN Life Sciences provides a unified system that reduces IT costs and speeds up implementation.
9. Gain significant cost savings: Eliminate the need for separate licenses, support contracts, and system integrations associated with using multiple software. Achieve significant cost savings over time, reduce administrative overhead, and allocate resources more efficiently. STAEDEAN Life Sciences offers a simpler tech stack that requires fewer customizations, fewer integrations, less validation effort, and lower maintenance costs.
10. ISO/IEC 27001 certification: STAEDEAN's ISO/IEC 27001:2022 certification is a testimony that it meets global standards for quality and information security. The certification demonstrates that STAEDEAN offers stronger data security, reduced compliance risks, robust privacy protection, and lower risk of data breaches.
Prepare your Business for the Future with STAEDEAN Life Sciences
STAEDEAN Life Sciences equips pharmaceutical, biotech, and clinical supplies companies with industry-focused solutions integrated into Microsoft Dynamics 365 Finance and Supply Chain Management (F&SCM).
Purpose-built for life sciences, our comprehensive ERP solution streamlines compliance, helping you meet stringent regulatory standards while delivering safe, high-quality therapeutics efficiently.
STAEDEAN Life Sciences is more than just an ERP—it's a unified platform designed to align with your operational and financial goals. Fully embedded in AI-enabled Microsoft Dynamics 365, it offers smart financial insights and simplifies implementation, validation, and usage.
Future-proof your business by accelerating time to market, reducing operational costs, and strengthening supply chain resilience. With STAEDEAN Life Sciences' advanced capabilities, you can embrace innovation, adapt to industry changes, and stay ahead of the curve.