The official launch meeting of the DMS/TMS digital project for Nanjing Zhengke Pharmaceutical Co., Ltd. was successfully held recently. It marks that the Document Management System (DMS) and Training Management System (TMS) undertaken by Hippocrates have passed comprehensive verification and closed-loop testing, and been officially put into operation.
As a milestone achievement following the project kick-off, the launch enables Zhengke Pharmaceutical to realize compliant, digital and integrated whole-lifecycle document management and staff training management, laying a solid foundation for full-process control of pharmaceutical R&D, production and quality management.
01 Full Project Delivery & Complete Compliance Verification
Implemented strictly in line with Zhengke’s URS requirements, the DMS/TMS project adopted on-premises deployment and completed full-process CSV validation within 5.5 months, delivering a full lifecycle solution from requirement design to official launch.
Complying with pharmaceutical GMP, FDA and NMPA regulations, Hippocrates delivered a complete set of traceable audit-ready validation deliverables:
- User Requirement Specification (URS)
- Validation Plan (VP) & GXP relevance assessment
- Functional Risk Assessment (RA/FRA)
- Functional & Technical Design Specification (FDS/TDS)
- DQ/IQ/OQ/PQ qualification
- Requirement Traceability Matrix (RTM) & Validation Report (VR)
- The full validation package fully meets pharmaceutical regulatory and internal quality control standards.
02 Official System Launch & Comprehensive O&M Support
System portal access information was released at the launch meeting for authorized group users to log in the Aotai platform directly. Hippocrates provided standardized operation manuals, modular tutorial videos and systematic on-site training to ensure quick adoption and standardized application.
A full-cycle service system combining on-site support + long-term remote maintenance was established: on-site resident service with centralized training and one-on-one Q&A ensures smooth system transition; dedicated remote support enables rapid response, remote troubleshooting and sustained stable operation with compliant updates.
03 Project Value & Achievements
The successful launch delivers core benefits to Zhengke Pharmaceutical:
- Upgraded document compliance: Unified filing, version control and clear permission management with full traceability, eliminating traditional pain points such as messy archives, version confusion and audit difficulties.
- Intelligent & efficient training management: Covering compliance training, skill training, assessment & certification and learning hour statistics; all records are traceable to meet regulatory audit and talent development needs.
- Closed-loop digital management: DMS and TMS are interconnected to build a compliant management system of controlled documents → standardized training → full traceability, greatly improving operational efficiency and risk prevention capability.
04 Remarks from Both Parties
Zhengke Pharmaceutical’s project leader stated that the DMS/TMS launch is a key step in corporate digital transformation. The system fully satisfies GMP requirements and greatly improves document and training management efficiency, acknowledging Hippocrates’ professional, rigorous and high-efficient delivery and service.
Hippocrates project team pledged to guarantee long-term stable system operation with professional expertise and sound O&M services. Both sides will deepen strategic cooperation to drive continuous breakthroughs in quality compliance, operational efficiency and innovative development for Zhengke Pharmaceutical.
05 About Zhengke Pharmaceutical
Founded in 2001 and listed with stock code 836342, Nanjing Zhengke Pharmaceutical is an innovation-driven pharmaceutical group integrating R&D, production and sales, owning two wholly-owned subsidiaries. As a national high-tech enterprise, it has won many industry honors and holds 25 independent invention patents.
Adhering to the vision of Accompanying Health, Benefiting the Public, the company offers reliable and effective medicines covering oral solid/liquid preparations, small-volume injections and powder injections. Its competitive products cover cardiovascular, neuropsychiatric, urinary and anesthetic therapeutic fields.
06 About Hippocrates
Derived from Hippocrates, the Father of Ancient Greek Medicine, Hippocrates is a leading digital solution provider in China’s life and health industry. It empowers pharmaceutical, medical device and cosmetic enterprises with digital transformation, covering GMP quality management, digital factory construction, GVP pharmacovigilance and GCP clinical research.
It has served over 300 domestic clients, set up overseas branches and established partnerships with multiple multinational enterprises.
