每天，生命科学组织都依靠他们quality management system (QMS)to drive people and processes to improve product quality, minimize risk, ensure patient safety, and help maintain regulatory compliance. A next generation QMS delivers even greater value by taking an organization’s quality maturity to the next level, also ensuring your operation is efficient and inspection-ready.
让我们看一下下一代QMS如何提高您的质量成熟度并检查五个关键特征，从而使技术能够优化您的质量系统性能。
Advancing your quality maturity
质量成熟度可以积极影响质量的总成本。那些在质量成熟度之旅中进一步发展的组织受益于质量较低的成本。
在成熟度的开始阶段，过程是手动和反应性的。与质量提高驱动相反，它们主要是由合规驱动的。此阶段的许多组织都面临GXP准备就绪和合规性的挑战，例如医疗设备行业的欧盟MDR等新法规。
随着组织成熟度的提高，重点转移到预防上，组织变得更好地预测和管理风险。这可以由集成质量和IT系统驱动和支持。在较高的质量成熟度阶段，公司变得更加积极主动，可以在整个企业乃至四堵墙之外进行协调，以更好地管理供应商质量和其他合同活动。
在最高水平的成熟度上，组织在质量的真实文化中运作，端到端质量流程以及指标有助于维持和提高整体质量的能力。
The goal of this journey is to achieve higher stages of maturity to gain the benefits of higher product quality, improved compliance, and reductions in overall cost of quality.
5 key characteristics of a next generation QMS
- Built for Life Sciences- 符合严格的监管要求，至关重要的是，您的QMS已准备就绪，并且闭环为准确性和效率至关重要。专门建造的集成QMS应有助于消除孤立的系统，推动协调，降低质量的总体成本，并实现知情的，数据驱动的决策，同时帮助您的组织遵守21 CFR等行业法规。
- 优质智能和报告- 轻松访问完整，准确的质量系统数据对于做出知情，数据驱动的决策至关重要。强大的商业智能（BI）与标准报告相结合，应立即提供质量趋势的反馈，使您的团队能够在正确的时间做出正确的决定。个性化的仪表板应允许下一代QMS用户轻松地操纵数据并调整其视图，以便他们看到最相关的信息。
- Cloud- 高度安全，可靠，高效的云环境将在符合行业兼容的环境中保护您的质量系统数据。云应随着业务发展而扩展，以满足您不断变化的业务需求。
- 端到端的EQM部署和优化– In order to optimize your next generation QMS deployment, the solution provider needs deep life science expertise to aid your organization in your journey to process harmonization and the achievement of proactive quality.
- 直观和现代用户界面（UI）- Having a consumer-grade user interface improves user adoption and allows for the inclusion of myriad users across the organization. The simplification of tasks improves user acceptance, utilization, and inclusion. An intuitive user interface can assist in shortening cycle times, reducing errors, and minimizing training needs. The user interface for a next generation QMS needs to be simple enough for the casual user, yet powerful enough for administrators and experts.
SmartSolve®, a Next Generation QMS
SmartSolve®, from IQVIA,helps organizations like yours maintain efficient and compliant quality management systems. SmartSolve’s integrated platform enables quality to become a centralized hub for continuous improvement throughout your business. For additional information about this next generation QMS, download the事实说明书。
让我们谈谈！Schedule a personalized discovery session with one of IQVIA’s QMS solution experts today. We'll review your current quality processes and show you how to get the most out of them using SmartSolve.
