高对比度
From GMP and supply chain issues to 退款, 退税, gross to net (GTN) and government pricing (GP), today’s life sciences organizations face increasingly complex operations. 获得更大的数据可见性对于保持敏捷性和应对挑战至关重要. 几十年来,, RSM has been a trusted advisor to biotechnology, pharmaceutical and medical device companies, 提供创新的微软 Dynamics生命科学解决方案,以满足他们的数字化转型需求.
RSM的Dynamics 365生命科学加速器和解决方案在单个基于云的解决方案上提供企业范围的可见性, enabling contract management, cGMP和联邦法规(CFR)第11部分合规性和假冒保护. 这是一款面向生命科学公司的ERP,它将Dynamics与GMP连接在一起, 验证, CMO和第三方物流的整合, 退款, 退税, GTN和GP. 全面的平台使您的组织可以自由地进行创新,而不会分心.
RSM如何提供帮助:
RSM’s 微软 life sciences advisors have decades of experience building, operating and supporting biotechnology, pharmaceutical and medical device companies. 我们利用丰富的经验和客户意见,为生命科学制造商创造有价值的最后一英里解决方案. 结果是, we are the go-to advisor for middle market companies in evaluating, 选择, implementing and supporting 微软 solutions.
生命科学公司,如制药和医疗器械制造商,正在努力遵守当前良好生产规范(cGMP)。, 21 CFR Part 210 & 211, 第11部分, and Part 820 in their ERP systems, require a subset of capabilities to meet compliance standards. 追踪的需要, 跟踪和计划供应链合作伙伴的材料,如合同制造组织(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.
被认为对cGMP至关重要的交易包括遵守21 CFR 210 & 第11部分(单和双电子签名),材料控制和制造限制. 除了, 普遍的外包商业模式推动了从活性药物成分(API)到CMO到CPO,最后到第三方物流的整个供应链的可见性和可追溯性的需求. From a commercial perspective, the ability to also plan demand, 库存, 整个供应链的生产是成功实现目标的关键. RSM在Dynamics 365之上建立了“最后一英里”功能,以支持内部制造和外包给服务提供商.
A comprehensive contract, chargeback, and rebate system with Gross to Net
美国司法部对制造商处以数十亿美元的罚款,原因是他们向美国政府提供了不准确的定价. 根据法律,制造商必须以最优惠的价格向政府出售产品.g. Medicare recipients, Military, VA, etc). 今天, 制造商购买并集成到合同管理系统,帮助他们管理销售和分销合同. These systems are often expensive, 考虑到几乎实时地进出这些系统的ERP事务和主数据的数量,集成可能会很复杂. RSM开发了一种解决方案,可以将所有数据和计算保存在Dynamics 365中,这可以为我们的客户节省数十万美元.
In conjunction with 行业 experts, RSM开发了一个收入合同管理(RCM)解决方案——一个全面的合同维护, 退款处理, 退税管理, and Gross to Net solution that also manages government pricing, 340 b报告, 分析和报告.
我们的微软医疗设备顾问团队将帮助您构建医疗设备制造所需的独特解决方案. To alleviate pricing pressure, maintain regulatory compliance, improve data and visibility across the organization, and optimize production planning, 我们的微软顾问将帮助构建和部署解决方案,以更好地管理和控制成本, 提高利润和利润率, and achieve sustainable growth and success.
具有重要的全球制造业背景和丰富的经验, RSM的微软顾问实现了帮助捕获和管理合同相关数据的解决方案, streamline contract management, 改善分包商管理,实现实时可见性和透明度,以符合现行良好生产规范(cGMP)标准.
We work to streamline life-cycle product management, strengthen quality management solutions, improve recipe and formula management, increase 库存 visibility, create recall-response plans, strengthen cGMP compliance, and control and secure data access.
RSM的生命科学加速器和解决方案在单个基于云的解决方案上提供企业范围的可见性, enabling contract and chargeback management, cGMP and Code of Federal Regulations (CFR) 第11部分 compliance, counterfeit protection and 验证 services.
Tailored for clinical trials, RSM的微软解决方案和加速器帮助生命科学公司最大化增长机会, 提高数据可见性, scale resources for efficiency and build engagement in clinical trials.
约翰•Hulburt Vice President and Corporate Controller