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Microsoft Dynamics® 365 pharmaceutical manufacturing solutions
With a reputation within the life sciences industry as a leading technology solutions provider, RSM is home to both one of the largest and most comprehensive Dynamics 365 (formerly Dynamics AX) practices in the United States as well as some of the most recognized Microsoft developers across the globe.
Combining their deep industry knowledge, extensive technical experience, and the highest-level Microsoft partnerships and certifications, RSM consultants are ideally positioned to bring pharmaceutical manufacturers high-value Dynamics 365 ERP solutions, tailored specifically to meet their complex and stringent requirements. These flexible, scalable, end-to-end solutions enable them to streamline operations, respond to market opportunities, and ensure full visibility and compliance—all while maximizing operational efficiencies that boost margin and profit.
Modern pharmaceutical manufacturing—challenges of complexity and compliance
With total revenues reaching $1 trillion and an annual growth rate averaging 3 percent from 2011 to 2016, global pharmaceutical manufacturing is considered to have at least modest opportunity for growth and profitability, stemming partially from increasing demand from emerging economies and elderly populations in developed economies.
Yet capturing these gains remains extremely challenging, with manufacturers forced to address tightening regulatory requirements, increased expectations around transparency, and revenue leakages attributed to complex accounting requirements such as incorrectly applied chargebacks—all of which cut directly into what are often—particularly for generic manufacturers—already tight margins.
RSM understands business drivers and requirements in pharmaceutical manufacturing
With years of success working with life sciences companies, RSM’s Dynamics 365 consultants are experienced providers of the specialized solutions and functionality needed by these highly complex and stringently regulated manufacturers, delivering systems able to:
- Streamline life-cycle product management: Seamlessly support pharmaceutical product production and distribution, from initial planning to final execution, with robust data capture and measurement tools that track and follow critical information as it travels across the supply chain, identifying any areas of weakness, inefficiency or resource drain to improve margin.
- Control and secure data access: Establish role-based security and version-control protocols to monitor user access to often sensitive company data and process information, leveraging change management tools to deliver immediate insight into all information updates. Work only with approved vendors to reduce risks and liabilities associated with procuring key ingredients.
- Strengthen quality management controls: Meet standards for quality and transparency across the industry—such as those mandated by the U.S. Food and Drug Administration (FDA), Department of Justice, Drug Enforcement Administration and the Worldwide Ministries of Health—by ensuring robust protocols and processes around product inspection, testing and ingredient availability.
- Improve recipe and formula management: Create accurate formulas every time through automated, percent-based formulations, tailored to meet a range of production lot sizes. Scale resources and easily calculate and plan production quantities based on actual lot potency, managing bulk production and packaging as required by utilizing lot number inheritance from bulk goods to final, packaged products.
- Expand inventory oversight: Categorize ingredients and products by assigning key attributes to each, tracking these goods as they change hands across the enterprise.
- Create recall response plans: Minimize time and resources required to respond to mock and actual product recalls by maintaining visibility into real-time activity across the manufacturing supply chain. Quickly identify the status of all lots—whether they’re in stock, works in progress or delivered to customers.
- Strengthen cGMP compliance: Ensure proper design, monitoring and control of functions in and around manufacturing processes and facilities to meet Current Good Manufacturing Practice (cGMP) requirements. Centrally manage supplier, receiving, quality, material issue, shop floor control, traceability and serialization data, leveraging electronic record-keeping procedures to drive compliance.
RSM consultants are experienced in delivering solutions that enable pharmaceutical manufacturers to improve operational visibility and efficiencies while complying with myriad regulatory requirements—allowing them to control costs, maintain profit margin, and drive long-term growth and success.
Powerful Dynamics 365 solutions, perfected for pharmaceutical product manufacturers
The Dynamics 365 platform provides functionality designed specifically to give pharmaceutical manufacturers the capabilities they need to optimize operational efficiency, achieve regulatory compliance, and control costs, with features that include:
- Enterprise-wide, single-platform visibility and control: Streamlining and automating the control and management of huge volumes of operational data—using a single, fully integrated, end-to-end solution built on the flexible, scalable Dynamics 365 platform—pharmaceutical manufacturers are able to gain real-time visibility into business-critical, enterprise-wide information, reducing and often eliminating the direct and indirect costs associated with inaccuracies, time investments and poor decision-making that accompany manual processes and use of disparate legacy tools such as spreadsheets.
- Contract and chargebacks management: Complexity, time constraints, volume pressures and rigid data accuracy requirements combine—in the absence of a technology solution specifically designed to provide this level of functionality— to make effective management of contracts and chargebacks nearly impossible, despite the importance of both to cost control and profit margin. RSM’s deep knowledge of the industry enables them to offer a Dynamics 365-based solution that addresses complex requirements around massive data volumes, nonstandard pricing, management fees and rebates, and regulatory compliance. With each potential chargeback jeopardizing margin, an automated validation process relying on up-to-date information on contracts, prices and memberships is considered to be a“must-have” functionality for pharmaceutical manufacturers needing to ensure that only valid credits are authorized and processed.
- cGMP and Code of Federal Regulations (CFR) Part 11 compliance support: RSM’s industry-specific, Dynamics 365-based solution ensures pharmaceutical manufacturers are able to comply with predicate rules governing their regulatory obligations—around quality, safety and intended use—driving consistent compliance by tracking GMP operations such as lot status identification, work order processing, batch release processing and quality control approvals. Best practices are also promoted throughout the supply chain, with GxP-compliant development, manufacturing, inventory and supply chain management supporting rework activities, co- and byproducts, contract manufacturing, in-process quality, container and sublot management, skill management for manufacturing, and quality and project management.
- Counterfeit protection: Assigning serialization to the saleable end unit, pharmaceutical manufacturers are better able to defend against counterfeit products, complying with chain of custody requirements to track goods to the most granular level across the supply chain to ensure authenticity, potency and safety.
- Validation services: To comply with requirements from the FDA—and similar regulatory agencies worldwide—that pharmaceutical manufacturers validate the implementation and intended use of their software systems (rather than the software itself), life science manufacturers are compelled—when implementing or upgrading their software—to conduct system validation that is specific to a particular site and release. To support these requirements, RSM’s solutions for pharmaceutical manufacturers provide functional documentation, test protocols and scripts, a validation document portal, and other services and resources necessary for them to efficiently and effectively validate their instance of Microsoft Dynamics 365—all of which substantially reduces the costs and time required for software qualification.
Strategically designed to help pharmaceutical manufacturers in the life sciences industry meet these and other functionality requirements, RSM’s verticalized, end-to-end, Dynamics 365-based solution enables these clients to fully comply with parameters around visibility, safety, quality, validation and even cost control—maximizing operational efficiencies to transform their market opportunity into sustainable margin and profit.
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