无论是定期服用还是在紧急情况下服用，许多消费者的生活都依赖于药物可靠地有效，始终如一，并且在需要时可用。所有参与临床产品生态系统和供应链的参与者，包括赞助商，供应商，CRO，临床站点和利益相关者，在确保整个产品生命周期中的产品质量方面都可以发挥作用。采用更新的质量管理技术是具有多个好处的基本步骤：首先，从业务角度来看，增强产品质量几乎总是会导致更高的企业价值；其次，实施自动化质量流程，政策和系统可以增强整个产品生态系统的质量文化，这是许多与质量管理系统和临床产品生命周期有关的许多新政府机构监管要求的核心概念。

A quality management system (QMS) is a formalized system of documented processes and procedures that outline an organization’s responsibilities and guide activities to meet customer expectations and regulatory requirements. Basic QMS approaches focus on compliance with U.S. Food and Drug Administration (FDA’s) Current Good Manufacturing Practice (cGMP) guidelines and collect general operational metrics, providing reactive solutions when issues arise.

由于2019年的毒品短缺和供应链问题的发病率增加，FDA认可采用“专注于持续改进和早期检测的成熟质量系统”of potential obstacles through the collection of quality metrics data. Thus, the development of stronger, more advanced electronic QMS (eQMS)平台为组织提供了一个宝贵的机会，可以自动从其流程中提取关键信息，以指导改进，为购买者提供透明度，并减少整个临床操作管道中与质量相关问题的可能性。

In this article, we’ll review how advanced eQMS adoption can improve product quality, enable sustainable compliance, foster continuous improvement and create a culture of quality that will make a positive impact for every stakeholder involved in the pharmaceutical product lifecycle.

A foundational component of clinical integrity & efficiency

QMS从传统纸质杂交系统和独立的QMS演变，本地数字系统转化为基于云的高级EQM可以增强多个领域的临床开发和制造。高级EQM不仅提供了更详细的质量指标，而且还确保了全部整个管道中的数据点和交换。

为了了解这种转变的价值，我们可以考虑杂货店。过去，出纳员必须在客户签出时手动输入每个物品的个人价格。这是一个缓慢的过程，每个条目都为人为错误提供了机会，因为收银员在登记册上打字。每个错误都需要时间来纠正这些错误，而耐心的客户遇到这些错误可能会失去对商店的信任或满意。

旧版纸质杂种QMS提出了类似的局限性：物理文档有人为错误的风险，例如缺失签名，错误报告的价值甚至丢失的文档。自从杂货店中引入条形码扫描以来，质量已经提高，杂货店可以汇总有关客户购买方式的详细信息。同样，高级EQM自动捕获有关质量过程的详细信息，并确保这些数据的真实性。通过将EQMS生态系统扩展到组织内部和外部的利益相关者，第三方可以直接与基于云的平台进行交互，而不必依靠较不安全的方法（例如电子邮件）。Additionally, eQMS guarantees the accuracy of an audit trail, providing additional assurance of data quality at every step.

优先考虑患者和消费者

Advanced eQMS also provides value for patients and consumers by reducing the risk of drug shortages or quality issues. Unlike a centralized, on-premises QMS platform, cloud-based eQMS connects all stakeholders throughout clinical development and manufacturing pipeline to enable real-time information sharing. This detailed flow of data and specific metrics is critical for product quality and, in turn, consumer safety.

With a reliable record of quality for all product components at every stage, patients can have confidence in every dose of a drug. If a manufacturer or supplier encounters a problem that would compromise patient safety, they can immediately report it across the pipeline, allowing the relevant parties to take action. For example, a supplier could instantly notify all participants throughout the entire clinical operations supply chain of a recall on a specific batch of vials, reducing the risk of patients receiving a potentially hazardous product.

Advanced eQMS can also offer insights into potential causes of such issues, allowing stakeholders to intervene before production is disrupted. By collecting advanced metrics, manufacturers can use data-driven approaches to identify pain points at every stage and continually improve performance and efficiency. As a result, patients can rely on consistent product safety, quality and availability.

证明了分散的实用程序

高级EQM对于支持分散的临床操作也至关重要。COVID-19大流行说明了需要一种有效的方法来完成培训，访问记录和收集签名，而无需亲自开会或发送物理文件。基于云的EQM允许各方共享和访问信息，同时保持监管合规性，无论其身体位置或隶属关系如何。随着组织转移到单个公司内的多个云提供商和系统，多个基于云的系统之间的连通性对于促进无缝的临床数据共享，分析，报告和趋势的关键质量指标越来越重要，而这些密钥质量指标最近由监管机构授权。

借助连接，集中且易于访问的质量数据存储库，所有临床质量记录都可以更好地组织起来，并立即为临床生态系统中的每个利益相关者立即获得，这是传统或本地数字QMS不可能的。简而言之，无论其隶属关系或位置如何，都可以立即与生态系统中的所有各方共享广泛的知识库。无论是产品召回，不良事件，还是简单地对必要材料培训新员工，先进的EQM都可以通过自动数据集中式和集中式报告，趋势和指标来支持增强的运营效率，为整个临床生态系统中的所有方面的各方。

高级EQMS将如何向前驱动药物？

在2020年，FDA引入了Quality Management Maturity (QMM) Pilot Program, which sought to objectively evaluate the state of QMS for drug manufacturers. In this program, facilities throughout the pharmaceutical pipeline are assessed and rewarded for mature quality management practices, with an emphasis on robust quality metrics and continual data-driven improvement. Advanced eQMS adoption is a cornerstone of QMM, providing insights into manufacturing timelines, patterns in stakeholder relationships across the pipeline, and more. These data trends allow facilities to anticipate potential obstacles and intervene proactively, ensuring a robust supply chain. With fewer disruptions, inefficiencies or errors, organizations can do their best work in delivering quality products to the patients who need them.

Advanced eQMS adoption will also fuel innovation from smaller players in the pharmaceutical sphere. Cloud-based systems are faster to implement and more flexible for growth than legacy systems, and no longer require dedicated software installation on specific computers in the organization. Instead, players inside and outside the organization alike can access advanced eQMS and operations can easily scale up as the company grows.

尽管实施新的QM可能会提前产生巨大的成本，但采用了连接，集中式，灵活，可扩展和开放的高级EQMS技术可提供有意义的投资回报。人为错误和持续过程改进的机会的减少也可以等同于降低成本，并且采用先进的等式也为即使是最小的公司增加了巨大的企业价值。优先级的质量管理反映了以一致和可靠的方式制造高质量药品的承诺，从而使临床质量生态系统中所有利益相关者受益。每个步骤中每个产品组成部分的质量记录都将继续促进患者可以信任的药物管道。