Elevate Your QMS with Gap Assessment Services┆QMS差距评估服务⟴提升质量管理体系

文摘 2024-12-20 12:50 上海

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Elevate Your QMS with Gap Assessment Services

提升您的质量管理体系 - QMS差距评估服务

In the fast-paced world of biopharma drug development industry, maintaining a robust and compliant Quality Management System (QMS) is not just a regulatory requirement - it’s a cornerstone for operational excellence and long-term success. At Widler & Schiemann Ltd. (WS), we specialize in providing comprehensive QMS gap assessment services to help organizations like yours identify, address, and optimize quality management practices.

在快节奏的医药研发行业中，保持一个健全且合规的质量管理体系(QMS)不仅是监管要求，更是运营卓越和长期成功的基础。卫森医药咨询（上海）有限公司专长提供全面的QMS差距评估服务，帮助医药研发公司识别、解决并优化质量管理实践。

私信后台与卫森团队联系QMS顾问服务

Never be too big to ask questions, never know too much to learn something new.

永远不要觉得问题太小而涩于提问，也不要觉得懂得够多而无法学习新东西。

– Og Mandino

What is a QMS Gap Assessment?

QMS差距评估是什么？

A QMS gap assessment is a thorough evaluation of your organization’s current quality management processes, focusing on compliance with Good Practice (GxP) standards such as ICH GCP, US FDA, EMA, and China NMPA regulations. Our team reviews your Standard Operating Procedures (SOPs), working documents, and operational workflows to pinpoint gaps and recommend actionable improvements.

QMS差距评估是对公司的当前质量管理流程的全面评估，重点关注与GxP标准的合规性，如ICH、美国FDA、欧盟EMA和中国NMPA法规。我们的团队会审阅您的SOP和相关运营流程文件，以识别差距并提出可行的改进建议。

Why it matters? QMS差距评估的重要性

Non-compliance or inefficiencies in a QMS can lead to regulatory hurdles, project delays, costly ramifications, and reputational damage. A well-designed QMS ensures seamless operations, mitigates risks, and positions your company for future growth and expansion.

QMS中的不合规或低效率可能导致申报受阻、项目延误、高昂的补救费用、和声誉受损。一个设计良好的QMS可确保顺畅的运营、降低风险，并为公司未来的增长和扩展奠定基础。

Our Step-by-Step Guide to QMS Gap Assessment

我们的QMS差距评估步骤

At Widler & Schiemann Ltd., we follow a structured approach to deliver a QMS gap assessment that meets your specific needs. Our process is designed to provide actionable insights while minimizing disruption to your ongoing operations. Here’s how we ensure your Quality Management System is compliant, efficient, and future-ready:

卫森医药咨询（上海）有限公司采用结构化的方法，提供满足您特定需求的QMS差距评估。我们提供实操建议的同时最大限度地减少对您现有运营的干扰。以下步骤是我们的QMS差距如何确保您的质量管理体系合规、高效并为未来做好准备：

Initial Consultation and Scope Definition 初步咨询和确定范围

Objective 目标：Understand your organization’s goals, regulatory landscape, and specific challenges.

了解您的组织目标、监管环境和具体挑战。

Process 流程：Hold a kick-off meeting with key stakeholders and department members to define the assessment's scope, such as targeted SOPs, critical processes, and functional areas like Clinical Operations, Medical, and Pharmacovigilance.

与关键利益相关者及部门团队成员召开启动会议，定义评估范围，例如目标SOP、关键流程以及临床运营、医学、及药物警戒等职能领域。

Document Review 文件审阅

Objective 目标：Identify gaps, redundancies, and non-compliance in your current documentation.

确定您当前文件中的差距、冗余和不合规之处。

Process 流程：Conduct a deep dive into existing SOPs, working instructions, and quality documents, assessing:

深入审阅现有SOP、工作指令和质量文件，并评估：

Completeness 完整性: Are the required SOPs in place? 必要的SOP是否到位？

Compliance 合规性: Do the documents align with GxP standards? 文件是否符合GxP标准？

Feasibility 可行性: Are the procedures practical for your operations? 程序是否适用于您的运营？

Outcome 结果：A preliminary findings report highlighting key document gaps and areas for improvement.

提供初步发现报告，指出关键文件差距和改进领域。

Stakeholder and Department Members Interviews 利益相关者及部门团队成员访谈

Objective 目标：Gain insights into how your QMS operates in practice.

深入了解您的QMS在实际操作中的运行方式。

Process 流程：Conduct interviews with personnel from key functional areas, including Clinical Operations, Quality Assurance, and Drug Safety, to understand:

与临床运营、质量保证、和药物安全等关键职能部门的人员进行访谈，以了解：

How procedures are implemented versus what is documented.

实际执行的程序与记录的程序是否一致。

Challenges faced by staff in adhering to existing processes.

员工在遵守现有流程时面临的挑战。

Cross-departmental communication and workflows.

跨部门沟通和工作流程。

Outcome 结果：A clearer picture of operational realities, providing context to our document review findings.

为文件审阅结果提供背景支持的实际运营情况剖析。

Comprehensive Gap Analysis 全面差距分析

Objective 目标：Synthesize findings into a detailed, actionable assessment.

将发现整合为详细且可操作的评估报告。

Process 流程：Evaluate your QMS against industry benchmarks and regulatory requirements.

根据行业基准和监管要求评估您的QMS。

Categorize gaps (e.g., critical, major, minor) based on their potential impact.

根据潜在影响将差距分类（例如，关键、重大、次要）。

Provide tailored recommendations to address deficiencies and improve efficiency.

提供定制的建议以解决缺陷并提高效率。

Outcome 结果：A comprehensive Gap Analysis Report that serves as the foundation for your QMS improvements.

提供一份全面的差距分析报告，为您的QMS改进奠定基础。

Actionable Roadmap 可操作的未来规划

Objective 目标：Provide a clear path forward to close identified gaps and optimize your QMS.

提供清晰的改进路径，以弥补已识别的差距并优化您的QMS。

Process 流程：Deliver a modular roadmap that includes short-term optimizations, long-term improvements, and best practices.

提供包含短期优化、长期改进和最佳实践的模块化计划。

Prioritize suggested actions based on urgency and impact.

根据紧迫性和影响优先排序建议的行动。

Key deliverables include revised SOP templates, training recommendations, and process optimization plans.

提供关键交付成果，包括修订的SOP、培训建议和流程优化计划。

Outcome 结果：A step-by-step guide that empowers your team to implement changes seamlessly.

提供逐步指导，帮助您的团队无缝实施变更。

Follow-Up Support 后续支持

Objective 目标：Ensure successful implementation of the recommended improvements.

确保成功实施推荐的改进措施。

Process 流程：We offer optional follow-up services, such as:

我们提供可选的后续服务，例如：

Training sessions for staff on updated SOPs and quality processes.

为员工提供关于更新SOP和质量流程的培训课程。

Periodic audits to monitor the effectiveness of implemented changes.

定期稽查以监控实施变更的有效性。

Assistance in preparing for regulatory inspections.

协助准备监管检查。

Outcome 结果：Sustainable improvements in your QMS, ensuring long-term compliance and operational excellence.

确保QMS的可持续改进，确保长期合规性和卓越运营。

By following this comprehensive process, Widler & Schiemann Ltd. ensures your QMS is robust, compliant, and tailored to your organization’s unique needs. Let us guide you through every step of the journey toward quality excellence.

通过以上的扎实步骤，卫森确保您的QMS健全、合规并适合您的公司的独特需求。让我们在实现卓越质量的每一步为您提供支持。

Client Success Cases 客户成功案例

In the recent five years, WS supported more than 30 clients in optimizing their corporate QMS. By conducting a gap assessment of 32 SOPs and engaging with cross-functional teams, we provided actionable insights to enhance compliance with global regulations and optimize their operational processes. We help clients to build amore resilient, scalable QMS ready for future challenges.

卫森在近五年间协助超过30家医研发企业进行QMS优化工作。通过差距评估及与跨职能团队合作，我们提供可行的见解，加强这些公司的QMS对全球法规的合规性并优化运营流程。我们帮助这些公司建立一个更有韧性、更具可扩展性的 QMS，随时准备迎接未来的挑战。

Why Choose Widler & Schiemann Ltd. 选择卫森医药咨询的原因

In-depth Experience: With consultants averaging 20+ years of experience across regulatory, clinical, and operational domains, we understand the intricacies of GxP compliance.

深厚的专业知识：我们的顾问在监管、临床、和运营领域平均拥有20年以上的经验，深入了解GxP合规的复杂性。

Tailored Solutions: Our recommendations are customized to align with your organizational goals and future growth strategies.

定制化解决方案：我们的建议是根据您的组织目标和未来增长战略量身定制的。

Global Perspective: We bring insights from working with regulatory authorities and biopharma organizations worldwide, ensuring your QMS meets global standards.

全球视角：我们从与全球监管机构和医药研发公司的合作中汲取洞见，确保您的QMS符合全球标准。

Let’s Work Together to Strengthen Your QMS 让我们一起提升QMS

Whether you're preparing for a regulatory inspection, expanding into new markets, or simply seeking to enhance operational efficiency, our QMS gap assessment services are your trusted solution. Contact us today to learn how Widler & Schiemann can help your organization achieve quality excellence.

无论您是准备监管检查、拓展出海，或是寻求提高运营效率，我们的 QMS 差距评估服务都是您值得信赖的解决方案。立即联系我们，了解卫森医药咨询（上海）有限公司如何帮助您的组织实现卓越质量。

Ready to take the first step? 准备好迈出第一步了吗？

Let’s start the conversation. Send us a message to discuss your QMS needs.

请留言给我们您的联系方式，我们会跟进联系，讨论您的QMS需求。

Get in touch and

meet our team!

ＷＳ卫森医药咨询(上海)有限公司

创建于瑞士；专家顾问团队布局德国、美国、中国，在医药行业或国际监管机构组织有平均20年的多元专业领域经验；擅长临床研发到商业化的GxP全过程战略构建、技术咨询与互动式培训，致力为国内外医药生技公司定制合规国际标准的质量及风险体系，並助力推动跨部门高效实践

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