01 Case Overview

Zhejiang Zhixing Pharmaceutical Co., Ltd. (hereinafter referred to as Zhixing Pharmaceutical) specializes in the R&D and production of high-end inhalation preparations. It boasts a first-class domestic R&D team and technical platform for inhalation products, focusing on independent, collaborative and commissioned development of high-end respiratory drugs for asthma, chronic obstructive pulmonary disease and other indications.

The company officially launched the GMP quality compliance digitalization (QMS) project in partnership with Shanghai Hippocrates Health Technology Co., Ltd. Based on the OwlTrust digital platform, an integrated quality compliance system covering Document Management System (DMS), Training Management System (TMS) and Quality Management System (QMS) was established.

The project realizes digitalized whole-lifecycle quality control, automated workflows and traceable data of pharmaceuticals, fully complying with regulatory requirements of NMPA, FDA, EMA and other authorities. It greatly elevates compliance management efficiency and quality control capacity, and accelerates the R&D, production and market launch of high-end inhalation preparations.

02 Project Background

Zhixing Pharmaceutical focuses on the high-end inhalation preparation track. Its core products include fluticasone propionate nebulizer suspension, beclomethasone dipropionate nebulizer suspension, salmeterol xinafoate and fluticasone propionate powder for inhalation, etc. Multiple products have completed bioequivalence trials and entered the marketing application phase, imposing stringent compliance requirements on R&D and production.

With increasingly sophisticated internal R&D and production procedures and tightening external regulations on data integrity, electronic records and audit trails, traditional paper-based and semi-manual management modes expose prominent drawbacks:

• Low efficiency and frequent errors in document drafting, approval, distribution, review and archiving, accompanied by chaotic version control;
• Time-consuming training arrangement, untraceable training outcomes and opaque management of employee qualifications and compliance competence;
• Offline handling of quality events including deviations, changes and CAPA leads to inadequate closed-loop supervision;
• Difficulties in data statistics and traceability fail to meet full-process traceability and inspection requirements under GMP standards.
• To adapt to the R&D and production pace of innovative drugs, consolidate compliance foundations and improve operational efficiency, Zhixing Pharmaceutical adopted Singerdi’s digital GMP quality compliance solution. Digital transformation drives quality system upgrading and guarantees full-lifecycle compliance and product quality of high-end pharmaceutical preparations.

03 Specific Measures

3.1 Overall Planning

The project follows a phased implementation strategy under holistic planning:

1. Phase 1: Complete digital transformation planning, sort out business status, clarify compliance demands and formulate implementation routes;
2. Phase 2: Launch DMS and TMS modules to build a fundamental quality assurance system;
3. Phase 3: Fully deploy QMS and roll out core modules covering deviation, change, CAPA, supplier management and audit management;
4. Phase 4: Realize system interconnection and data-driven decision-making, establish closed-loop whole-lifecycle pharmaceutical quality management and satisfy domestic and overseas regulatory standards.

3.2 Business Model

Core business capabilities are rolled out in phases in strict accordance with GMP compliance principles:

1. Digital transformation planning: status investigation, benchmarking analysis, process optimization, future architecture design and implementation roadmap formulation;
2. Document and training management (DMS/TMS): organization & personnel administration, full-lifecycle document control, online training assessment and qualification management;
3. Quality management (QMS): deviation, change, CAPA, audit, supplier management, validation, complaint handling, product recall and risk management;
4. Business intelligence and decision support: data lake construction, data mining, intelligent analysis, dashboard visualization and auxiliary decision-making.
5. Compliance consultation, risk assessment, CSV computerized system validation and staff training run through the whole project to ensure legitimate and stable system operation.

3.3 Technical Architecture

Deployed on Hippocrates OwlTrust digital platform, the QCMS system adopts microservice and distributed architecture with PC and mobile terminal accessibility, featuring high availability, scalability and compliance.

• Terminal layer: PC and mobile terminals catering to office and on-site operational scenarios;
• Application layer: document management, training management, quality management, system administration and external interface connection;
• Basic service layer: microservices, API gateway, OAuth2 authentication, workflow engine, distributed log and message push;
• Data storage layer: MySQL, Redis, OSS, MQ and Elasticsearch;
• Cloud platform: compatible with Huawei Cloud, Alibaba Cloud, AWS and other mainstream cloud environments;
• Integration capability: equipped with standard middleware layer for seamless interconnection with ERP, OA/BPM, LIMS, MES and other third-party systems to achieve data sharing and workflow collaboration.
• Embedded configuration tools for forms, workflows, reports and permissions support zero-code customization to adapt to personalized compliance workflows. Optimized functions including intelligent loading, cache acceleration, automatic notification and alert reminder effectively boost operational efficiency.

04 Project Achievements

4.1 Corporate Benefits

Within a 3-month construction period, DMS and TMS modules were successfully launched, with quality management scenarios being gradually fully covered. Integrated control of institutional personnel, documents & training, record release and quality assurance has been realized.

• Overall Operational EfficiencyReal-time accurate data with processing speed improved by 80%; optimized staffing structure with redundant statistical posts reduced.
• Quality Compliance EnhancementProduct quality traceability rate exceeds 90%; 100% compliance of data consistency and integrity with regulatory standards; strengthened real-time online quality monitoring and early warning capacity; Product Quality Review efficiency increased by over 20%.
• Error Risk ReductionOver 90% statistical errors and 80% manual operational errors eliminated.
• Document Management OptimizationDocument approval circulation speed up by around 30%; electronic coverage of batch production records, SOPs and auxiliary records surpasses 70%; document printing and consumable costs cut by about 80%; record filling and circulation time saved by over 50%.
• Training Management ImprovementOnline training assessment cuts overall organizational time by roughly 60%; training performance statistical efficiency rises by over 80%; on-the-job compliance training effectiveness improved by approximately 40%.

4.2 Social Benefits

High-end inhalation preparations are high-tech integrated pharmaceutical products, whose quality and compliance are closely linked to medication safety. Powered by Hippocrates QCMS, Zhixing Pharmaceutical achieves automated quality workflows, real-time risk monitoring, encrypted core documents and standardized training mechanisms.

A top-down closed-loop quality management framework is established to mitigate R&D and production compliance risks and guarantee stable supply of qualified high-end drugs.

This project sets a replicable digital GMP compliance benchmark for the inhalation preparation sector. It serves as a typical reference for innovative pharmaceutical enterprises to meet global regulatory requirements, strengthen quality control and accelerate product commercialization via digital means, further advancing the digital transformation of quality compliance across the pharmaceutical industry.

05 Relevant Solutions

1. GMP Quality Management Solution (QMS) for Pharmaceutical Enterprises
2. GMP Document Management Solution (DMS) for Pharmaceutical Enterprises
3. GMP Training Management Solution (TMS) for Pharmaceutical Enterprises

06 Relevant Cases

1. GMP Quality Compliance Digitalization (QMS) Project of Zhejiang Zhenyuan Pharmaceutical
2. GMP Quality Compliance Digitalization (QMS) Project of Shanghai Shenqi Medical