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

Services

QMS Upgrade

ServicesPlant QMSQMS Upgrade

Establishing and maintaining a controlled, traceable, and continuously improving Quality Management System throughout the entire product lifecycle is a core task for companies in the life sciences sector. In the current context of worldwide "import + export" and the comprehensive implementation of the MAH systems, the continuously changing and high-demand regulatory environment necessitates that a QMS must become a "living system" maintaining high adaptability and effectiveness. Only through continuous improvement can we effectively manage systemic risks arising from stricter regulations, cross-border compliance, and the expansion of primary responsibility in the global market.

As an international GMP consulting and execution company, gempex has extensive experience in upgrading QMS. Through professional compliance analyzis and one-stop system improvement services, we assist companies in implementing a quality management system that not only meets global compliance requirements but also supports business development.



Service Advantage

Multinational Compliance System
Our team comprises regulatory experts from various regions including China, USA, and EU, offering bilingual support in Chinese and English. It can simultaneously meet the differing GMP requirements in China, EU, USA, and other regions, assisting companies in establishing a unified and compatible quality management system, thereby enabling companies to  access national and international markets. 

Customized service
Based on the actual situation and needs of the customer, we provide tailored, pragmatic solutions for system optimization to ensure compliance and feasibility.

Broad audit experience
We have comprehensive audit experience in both domestic and foreign companies, are familiar with the operational characteristics of various systems, and are capable of accurately identifying weaknesses, introducing you to the industry’s best practices.

Coverage of multiple industries and the entire process
With service experience in multiple industries such as biopharmaceuticals, chemical drugs, medical devices, raw materials and packages, we provide one-stop full-process services from early gap analysis to continuous tracking in the later stages.

Continuous optimization and maintenance
We do not only focus on project execution but also attach great importance to knowledge transfer and the sustainability of the system.

advantage

Service Scope

We offer one-stop upgrade services covering the entire lifecycle of QMS, precisely addressing the needs of companies at different stages of development:


  • Gap analysis
    Based on the regulations of target markets (NMPA, FDA, the EMA, etc.), we systematically check the compliance of the company’s existing QMS with international regulations, identify gaps and points for improvement, and provide a risk classification report and propose practical actions for improvement in the form of a to-do-list.
  • Optimization of existing QMS
    For the existing system, we provide integrated upgrade services ranging from quality policy, process optimization, document upgrading to execution support.
  • Implementation of a new QMS system
    We provide QMS concept design and comprehensive support in system implementation and documentation services that meet international standards for new established companies, MAH holders (B-license enterprises), or new added production lines.


Service Workflow