• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Operating Monitoring

ServicesPlant QMSOperating Monitoring

The effective operation of the quality management system serves as the cornerstone for enterprises to maintain compliance. However, as the system involves collaboration across multiple departments, processes, and personnel, there is often a gap between its actual implementation effect and expected requirements. Internal monitoring mechanisms often struggle to address deep-seated issues due to limited resources and fixed perspectives, leading to hidden systemic risks, difficulties in promoting rectification, and escalating compliance costs.

gempex provides monitoring services covering the entire lifecycle of the quality system based on the "third-party independent perspective + dynamic monitoring technology". With our core "precise risk identification, efficient closed-loop rectification and continuous system optimization", we leverage an international expert team and modular tools to assist enterprises in breaking through the virtuous cycle of "monitoring-rectification-improvement", achieving a leap from "formal compliance" to "substantive effectiveness" in the quality system.

Service Advantage

Third-party independent perspective: Breaking through the limitations of internal perspectives, accurately identifying systemic risks and compliance gaps.

Comprehensive audit report: Provide detailed internal audit reports that not only point out issues but also offer specific improvement suggestions and optimization plans.

Full lifecycle coverage: The monitoring scope covers the entire lifecycle from research and development to production, ensuring quality control at every stage.

advantage

Service Scope

We provide systematic quality operating monitor services, mainly including the following two categories, which comprehensively cover the core modules of the pharmaceutical quality system:


  • Internal third-party audit
    Based on international and domestic regulatory standards such as NMPA, FDA, and EU GMP, we conduct a comprehensive compliance audit of the enterprise's quality system, laboratory control system, production system, facility and equipment system, material system, packaging and labeling system. We independently and objectively evaluate the operational status of the system, identify management loopholes and execution deviations, and provide structured audit reports.


  • Quality operating guidance
    For key and difficult issues identified during audits or routine management, we provide periodic and customized on-site or remote guidance.