Against the backdrop of accelerated digital transformation and increasingly stringent compliance supervision in the pharmaceutical industry, Nanjing Zhengke Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhengke Pharmaceutical") has entered an in-depth cooperation with Shanghai Hippocrates Health Technology Co., Ltd. (hereinafter referred to as "Hippocrates "), officially launching the Document Management System (DMS) and Training Management System (TMS) digital project. The project kick-off meeting was successfully held at Zhengke Pharmaceutical recently, marking the company’s entry into a new stage of full-lifecycle digital document management and standardized compliance-oriented training management. The digital infrastructure will bolster its high-quality innovative development.
I. Project Background
Founded in 2001, Nanjing Zhengke Pharmaceutical is an innovation-driven pharmaceutical conglomerate integrating drug R&D, manufacturing and sales. It is recognized as a national high-tech enterprise and a Jiangsu Provincial Specialized, Refined, Unique and Innovative Small Giant Enterprise. The company owns two wholly-owned subsidiaries: Guangdong Yongzheng Pharmaceutical and Nanjing Hengzheng Pharmaceutical Research Institute.
Its product portfolio covers oral solid preparations, oral liquid preparations, small-volume injections, powder injections and other dosage forms. It boasts core competitive advantages in cardiovascular and cerebrovascular, neuropsychiatric, urological, anesthetic and adjuvant medication sectors. Upholding the corporate vision of "Safeguarding Health, Benefiting Mankind", the company consistently delivers safe, high-quality and effective pharmaceutical products to the market.
With expanding R&D pipelines, growing production scale and rising global compliance requirements, traditional document and training management modes can no longer meet operational demands. Prominent pain points include disorganized document filing, confusing version control, low retrieval efficiency and difficult audit traceability. Meanwhile, irregular training systems, problematic academic hour tracking, incomplete compliance training coverage and unclear position-specific learning paths also hinder development.
The DMS and TMS project serves as a core strategic initiative for Zhengke Pharmaceutical to optimize quality compliance systems and advance digital transformation. Digital tools will enable closed-loop whole-process management of documents and training, substantially improving operational efficiency and compliance supervision capacity.
II. Project Kick-off Meeting
Co-hosted by project managers from both parties, the kick-off meeting gathered core project members. Participants conducted in-depth discussions on project overview, implementation scope, schedule management, organizational structure and full-process control mechanisms, clarifying implementation routes and collaboration protocols.
A multi-level project organizational framework was established. A project steering committee consists of general managers of both companies. Business Process Owners (BPOs) are appointed from senior management of Zhengke Pharmaceutical. Frontline business users of Zhengke Pharmaceutical and implementation consultants of Hippocrates form the joint project team, divided into DMS, TMS, CSV validation, development, operation & maintenance and data groups to ensure efficient progress and clear accountability.
Standardized full-process management rules were formulated. Regular communication mechanisms including weekly meetings, steering committee sessions and special seminars were set up. Unified classification and naming standards were adopted for planning, management and meeting minutes documents. A hierarchical issue handling process covering reporting, assignment, tracking and closure was defined. An independent Internal Quality Assurance (IQA) system was built alongside risk management and customer satisfaction evaluation to guarantee project delivery quality.
III. Leadership Remarks
Leaders of Zhengke Pharmaceutical stated that digitalization and compliance constitute the fundamental cornerstone for pharmaceutical enterprises’ sustainable development. The DMS and TMS project underpins quality system improvement and talent competency enhancement. The company will allocate sufficient key personnel resources and fully cooperate with implementation. Close collaboration with Hippocrates will facilitate rapid system deployment and practical application, empowering comprehensive upgrading of R&D, production and quality management, securing drug safety and fulfilling corporate commitments.
Chen Zhonghua, Project Director of Hippocrates , commented that Zhengke Pharmaceutical’s profound industrial expertise and rigorous compliance pursuit align perfectly with Hippocrates ’s original aspiration of "Creating Health Value through Technology". Hippocrates will deploy top-tier industrial experts and technical teams, complying strictly with GMP, FDA and other domestic and international compliance criteria. Customized solutions tailored to Zhengke’s business characteristics will be delivered on schedule with guaranteed quality, striving to build a benchmark digital compliance project of DMS and TMS in the pharmaceutical sector. Long-term cooperative ties will be further deepened to fuel Zhengke Pharmaceutical’s sustained digital transformation.
IV. Core Solution: DMS & TMS Digital Management System
Developed by senior GMP specialists and digital technology teams of Hippocrates , the customized DMS and TMS system complies with pharmaceutical industrial compliance standards, featuring outstanding compliance, stability and intelligence to resolve existing management bottlenecks.
- Document Management System (DMS)Covering compliant documents across R&D, production, quality assurance and registration, the system realizes full-lifecycle management including document creation, review, release, archiving, retrieval, version control, hierarchical authorization and expiration reminder. Standardized document architecture ensures traceability, controllability and audit convenience, meeting stringent GMP compliance requirements and eliminating drawbacks of conventional document management.
- Training Management System (TMS)Supporting company-wide compliance and professional skill training scenarios, the system integrates training planning, training matrix, course management, online learning, academic hour statistics, assessment evaluation, certificate administration and training traceability. Customized learning paths for different posts ensure full training coverage and complete record keeping, lowering compliance risks and boosting staff proficiency.
- The system undergoes complete CSV validation to ensure data integrity and traceable electronic signatures. It supports on-premises deployment and seamless integration with existing enterprise systems, constructing a secure, efficient and compliant digital management foundation for Zhengke Pharmaceutical.
V. Company Profile
About Zhengke Pharmaceutical
Listed under stock code 836342 and located in Nanjing Economic and Technological Development Zone, Nanjing Zhengke Pharmaceutical Co., Ltd. specializes in pharmaceutical R&D, production and sales with a range of well-recognized core products. It holds prestigious qualifications including Jiangsu Provincial Enterprise Technology Center, Jiangsu Provincial Neuropsychiatric Drug Engineering Technology Research Center and Jiangsu Provincial Postdoctoral Innovation Practice Base. Driven by innovation and committed to quality excellence, the company aims to grow into a leading domestic pharmaceutical enterprise.
About Hippocrates
Named after Hippocrates, the father of ancient Greek medicine, Hippocrates has over 20 years of industry experience. The company started with GMP compliance consulting and has grown into a leading provider of pharmaceutical digital solutions in China. We have participated in the drafting of national GxP digital standards and possess strong capabilities in both consulting and independent R&D. Our products comply with GxP standards and meet the regulatory requirements of global authorities such as the NMPA, FDA, EMA, and WHO. Our self-developed QMS, DMS, and TMS suites rank among the top tier in China. We also offer VDR, eSIGN, PVS, EBR, WMS, CGT, and eMAH solutions, along with one-stop services covering compliance control, data governance, and CSV validation, supporting both group-level and global deployment. Our clients include leading domestic pharmaceutical companies, benchmark biotech enterprises, and multinational pharmaceutical companies. To date, we have helped hundreds of companies achieve zero-defect audits, empowering pharmaceutical enterprises in digital transformation, cost reduction, efficiency improvement, and global growth.
