01 Case Overview

Nanjing Zenkom Pharmaceutical Co., Ltd. (stock abbreviation: Zenkom Pharmaceutical; stock code: 836342) was established in 2001. As a national high-tech enterprise and a Jiangsu Province "Specialized, Refined, Differential & Innovative" Little Giant Enterprise, it integrates drug R&D, manufacturing and product sales. The company has two wholly-owned subsidiaries: Guangdong Yongzheng Pharmaceutical Co., Ltd. and Nanjing Hengzheng Pharmaceutical Research Institute Co., Ltd. Its products cover multiple dosage forms including oral solid preparations, small-volume injections and powder injections, with core competitiveness in cardiovascular, neuropsychiatric, anesthetic and auxiliary medication fields.

With increasingly stringent regulation by the National Medical Products Administration (NMPA), pharmaceutical manufacturers face rising requirements for data integrity, document traceability and personnel qualification compliance. Zenkom Pharmaceutical’s traditional paper-based document management and offline training models could no longer meet GMP compliance and efficient management needs, exposing frequent shortcomings in internal self-inspections and inspection preparations. To fundamentally address compliance pain points and improve group-wide management efficiency, Zenkom Pharmaceutical officially introduced a digital solution from Shanghai Singedi Health Technology Co., Ltd. (Hippocrates Health). Based on the Hippocrates OwlTrust® digital platform, the company simultaneously implemented the GMP Document Management System (DMS) and Training Management System (TMS) project.

Adopting on-premises deployment and strictly adhering to CSV (Computerized System Validation), the project covered all business scenarios of R&D, production, quality and human resources. With the goals of "full-lifecycle electronic document management, end-to-end digital training, and one-click compliance inspection readiness", it built an integrated quality compliance system of "document control – training & learning – qualification certification – audit traceability". The project was fully delivered in 5.5 months, completed full CSV validation and passed internal compliance acceptance, achieving comprehensive upgrades in quality compliance, management efficiency and operational cost reduction, and laying a solid digital compliance foundation for the enterprise’s high-quality development.

02 Project Background

As an innovative pharmaceutical group with equal focus on R&D and production, Zenkom Pharmaceutical features a large R&D pipeline, complete production dosage forms, strict quality control and close cross-departmental collaboration. Under the dual pressure of stringent NMPA regulation and rapid corporate expansion, traditional document and training management models exposed numerous pain points, failing to meet GMP’s core requirements for data integrity, traceability, version control and personnel compliance:

(1) GMP Document Management (DMS) Pain Points

1. Inefficient Workflow: Batch production records, SOPs, quality inspection reports and R&D data were primarily paper-based, with long manual approval cycles and delayed cross-departmental transmission, severely impacting production scheduling and R&D progress.
2. Uncontrolled Versions & Security: Document versions relied on manual management, leading to risks of incorrect use of outdated SOPs and failure to retrieve obsolete documents. Access rights for core process parameters and R&D data were poorly defined, posing risks of confidential business information leakage.
3. Difficult Compliance Traceability: Paper documents occupied significant storage space, manual ledger statistics were error-prone, and retrieval/traceability during audits and inspections was extremely time-consuming, failing to meet GMP data integrity requirements.
4. Delayed Validation Management: CSV validation documents (URS, IQ/OQ/PQ, etc.) were numerous with long approval chains, and offline circulation delayed key milestones, directly affecting overall project launch timelines.

(2) Training Management (TMS) Pain Points

1. Simplistic Training Planning: Production, R&D, quality and management positions had vastly different skill requirements, but traditional "one-size-fits-all" training lacked precise position-competency-course matching, resulting in inadequate relevance and effectiveness.
2. Lack of Qualification Control: Expiry reminders for employee GMP certificates, post qualification certificates and work permits were absent, creating serious compliance risks of unqualified personnel working.
3. Inefficient Record-Keeping & Assessment: Training sign-ins, scoring and effectiveness evaluations were manual, with records prone to loss and difficult statistical analysis, failing to meet regulatory requirements for training effectiveness confirmation and full traceability.
4. Wasted Resources & High Costs: Training materials were fragmented and not shared across departments. Offline training required venue and schedule coordination, incurring high travel and organizational costs with low large-scale coverage efficiency.
5. Based on these pain points, Zenkom Pharmaceutical defined project objectives: realize full-lifecycle digital document control via DMS, build a closed-loop training-assessment-qualification management system via TMS, ensure NMPA and GMP compliance through deep system integration, complete full CSV validation, and ultimately achieve cost reduction, efficiency improvement, risk control and inspection readiness.

03 Specific Initiatives

Zenkom Pharmaceutical and the Hippocrates team jointly established a dedicated project team, advancing in five phases: "Initiation – Blueprint – Implementation – Validation – Go-Live", following the principles of unified planning, phased implementation, compliance priority and deep integration. Strict project management, organizational safeguards, documentation standards and quality control mechanisms were enforced throughout to ensure business alignment, compliance and smooth deployment.

(1) Overall Planning: Standardized Five-Phase Implementation Roadmap

1. Scope of Implementation Systems: Full coverage of DMS and TMS modules Compliance: Full CSV computerized system validation Data Security & Traceability: Ensured at all stages.
2. GMP Standard Template Library: Built-in industry-standard templates for SOPs, batch records, quality reports and validation documents, reducing manual drafting time and ensuring regulatory alignment.

(2) DMS System Construction: Full-Lifecycle Electronic Document Control

1. Electronic Document Management: Centralized repository for all GMP documents (SOPs, batch records, quality reports, R&D data) with version control, access rights management and full-text search, enabling real-time sharing and cross-departmental collaboration.
2. Electronic Approval Workflow: Customizable multi-level approval processes with digital signatures, eliminating manual circulation and significantly shortening approval cycles.
3. Automated Compliance Ledger: Built-in GMP standard templates auto-generate document directories, version lists, obsolete records and audit trail reports, enabling one-click export of inspection-ready materials.
4. Integrated CSV Validation: Validation documents initiated, approved and archived online, linked to business processes to ensure compliance, completeness and rapid retrieval of validation records.

(3) TMS System Construction: Closed-Loop Training-Assessment-Qualification Management

1. Position Training Matrix: Established position-competency-course matching for production, R&D, quality and management roles, auto-generating personalized training plans to ensure "training aligned with job requirements".
2. Online Learning & Examination: Supports material upload, version control, online learning, random test generation, anti-cheating exams and auto-grading, fully digitalizing processes and reducing organizational costs.
3. Automated Qualification Alerts: Tracks all employee qualification certificates with automatic expiry reminders, eliminating risks of unqualified or expired qualifications.
4. Traceable Training Effectiveness: Learning hours, assessment scores and qualification status are fully logged, enabling multi-dimensional retrieval by personnel, position, course and time, and one-click export of GMP-compliant training reports.

(4) System Integration: Deep DMS-TMS Synergy

Enabled document-training linkage: critical SOPs, new regulations and updated documents automatically trigger training for relevant positions. Personnel with incomplete training or failing assessments are restricted from system access, forming a true compliance closed-loop.

(5) CSV Computerized System Validation

Completed full-process validation in strict accordance with GMP and NMPA requirements, delivering complete validation packages for DMS and TMS, including URS, VP, GXP, RA, FDS, TDS, DQP/DQR, IQP/IQR, OQP/OQR, PQP/PQR, FRA, RTM, VR and other full documentation to ensure regulatory audit readiness.

04 Achievements

Over 5.5 months of implementation and rigorous CSV validation, the project delivered four core outcomes: compliance upgrade, efficiency improvement, cost reduction and risk mitigation, setting a replicable benchmark for pharmaceutical enterprises’ DMS+TMS digital transformation.

(1) Enterprise Outcomes

GMP Document Management (DMS)

• Significant Efficiency Gains: Document approval cycles shortened drastically; retrieval and statistical efficiency improved by over 80%; electronic adoption rate exceeded 95%; form-filling time reduced by over 50%.
• Full Compliance Assurance: Zero version control risks; full operational traceability; ledger generation time reduced from days to 1 hour. Successfully passed CSV validation and internal compliance audits with zero document-related findings.
• Substantial Cost Reduction: Paper, consumable and warehousing costs decreased by over 70%; elimination of production rework and raw material waste due to version errors.
• Enhanced Cross-Departmental Collaboration: Real-time document sharing and online collaboration accelerated R&D and production workflows, supporting efficient multi-pipeline R&D and large-scale manufacturing.

Training Management (TMS)

• Zero Qualification Risks: 100% qualification expiry reminder rate completely eliminated "unqualified personnel working" compliance risks; post assessment pass rates improved significantly.
• Quantifiable & Traceable Effectiveness: Training effectiveness statistical efficiency improved by over 70%; complete, retrievable records met regulatory requirements for "training effectiveness confirmation".
• Closed-Loop Management Established: Full digitalization of "training – assessment – qualification – document" workflows improved audit retrieval efficiency by 85%, significantly reducing compliance management costs.

Project Management Outcomes

1. Established a standardized project management system, issue/risk resolution mechanisms and deliverable acceptance processes, laying the foundation for future system expansion and maintenance.
2. Delivered comprehensive end-user training and on-site + remote technical support to ensure stable system launch and continuous operation.

(2) Industry & Social Outcomes

• Advancing Pharmaceutical Compliance: Validated the feasibility of the integrated DMS+TMS+CSV solution for pharmaceutical enterprises, providing a practical digital compliance reference for the industry.
• Promoting Green Manufacturing: Comprehensive paperless operations reduced paper consumption, supporting low-carbon and sustainable practices.
• Accelerating Innovative Drug Launches: Improved document and training efficiency shortened R&D and production cycles, enabling faster delivery of high-quality medications to patients.
• Strengthening Quality Assurance: Digital tools enhanced full-lifecycle drug quality control capabilities, safeguarding public medication safety.

05 Related Solutions

• Solution 1: GMP Quality Compliance Digital Solution (QMS)
• Solution 2: Pharmaceutical GMP Training Management Solution (TMS)

06 Related Cases

• Case 1: Zhejiang Zhenyuan Pharmaceutical GMP Quality Compliance Digital (QMS) Project
• Case 2: Suzhou Fule Pharmaceutical Co., Ltd. TMS Project