From GMP and supply chain issues to chargebacks, rebates, gross to net (GTN) and government pricing (GP), today’s life sciences organizations face increasingly complex operations. Gaining greater visibility into their data is vital to remain agile and address their challenges head on. For decades, RSM has been a trusted advisor to biotechnology, pharmaceutical and medical device companies, delivering innovative Microsoft Dynamics life sciences solutions to meet their digital transformation needs.
RSM’s Dynamics 365 life science accelerators and solutions provide enterprise-wide visibility on a single cloud-based solution, enabling contract management, cGMP and Code of Federal Regulations (CFR) Part 11 compliance and counterfeit protection. It’s an ERP for life sciences companies that connects the last mile between Dynamics for GMP, validation, CMO and 3PL integration, chargebacks, rebates, GTN and GP. The comprehensive platform leaves your organization free to innovate without distractions.
How RSM can help:
RSM’s Microsoft life sciences advisors have decades of experience building, operating and supporting biotechnology, pharmaceutical and medical device companies. We leverage our extensive experience and client input to create valuable last-mile solutions for life sciences manufacturers. As a result, we are the go-to advisor for middle market companies in evaluating, selecting, implementing and supporting Microsoft solutions.
Life Sciences companies like Pharmaceutical and Medical Device Manufacturers that are struggling to comply with Current Good Manufacturing Practices (cGMP), 21 CFR Part 210 & 211, Part 11, and Part 820 in their ERP systems, require a subset of capabilities to meet compliance standards. The need to track, trace and plan material at supply chain partners such as Contract Manufacturing Organizations (CMO), Contract Packaging Organizations (CPO), and Third-Party Logistic (3PL) companies are also a common requirements. RSM has built these capabilities into Dynamics 365 Finance & Supply Chain Management with our Life Sciences Essentials solution.
Transactions considered critical to cGMP include compliance with 21 CFR 210 & Part 11 (single and dual electronic signatures), material control, and manufacturing restrictions. In addition, the prevalent business model of outsourcing drives the need to gain visibility and traceability across the supply chain from Active Pharmaceutical Ingredient (API) to CMO to CPO and finally to 3PL. From a commercial perspective, the ability to also plan demand, inventory, and production across the entire supply chain is key to successful fulfillment goals. RSM has built the “last mile” capabilities on top of Dynamics 365 to support both manufacturing in house and outsourced to service providers.
A comprehensive contract, chargeback, and rebate system with Gross to Net
Billions of dollars in fines are handed down by the DoJ to manufacturers for inaccurate pricing to the US Government. Manufacturers, by law, are to sell product at the manufacturer’s best price to the government (e.g. Medicare recipients, Military, VA, etc). Today, manufacturers buy and integrate to contract management systems that help them manage sales and distribution contracts. These systems are often expensive, and the integration can be complex considering the amount of ERP transaction and master data that flows to and from these systems in near real time. RSM has developed a solution to keep all the data and calculations within Dynamics 365 which can save our clients hundreds of thousands of dollars.
In conjunction with Industry experts, RSM has developed a Revenue Contract Management (RCM) solution - a comprehensive contract maintenance, chargeback processing, rebate management, and Gross to Net solution that also manages government pricing, 340B reporting, analytics and reporting.
Our team of Microsoft medical device advisors will help you build the solutions uniquely required for medical device manufacturing. To alleviate pricing pressure, maintain regulatory compliance, improve data and visibility across the organization, and optimize production planning, our Microsoft advisors will help architect and deploy solutions to better manage and control costs, boost profit and margins, and achieve sustainable growth and success.
With a significant background and extensive experience in global manufacturing, RSM’s Microsoft advisors implement solutions that help capture and manage contract-related data, streamline contract management, improve subcontractor management and enable real-time visibility and transparency to comply with current good manufacturing practice (cGMP) standards.
We work to streamline life-cycle product management, strengthen quality management solutions, improve recipe and formula management, increase inventory visibility, create recall-response plans, strengthen cGMP compliance, and control and secure data access.
RSM’s life sciences accelerators and solutions provide enterprise-wide visibility on a single cloud-based solution, enabling contract and chargeback management, cGMP and Code of Federal Regulations (CFR) Part 11 compliance, counterfeit protection and validation services.
Tailored for clinical trials, RSM’s Microsoft solutions and accelerators help life sciences companies maximize growth opportunities, improve data visibility, scale resources for efficiency and build engagement in clinical trials.
John Hulburt, Vice President and Corporate Controller
RSM went out of its way to understand our business, our future goals and the way our team functions together.
Knowing where to start with Microsoft Dynamics 365 can be difficult. This buyer’s guide is designed to be a first step in understanding how to reap optimal value from Dynamics 365.