Hippocrates Digital Factory Solution: Empowering the Intelligent Transformation of the Life Sciences and Healthcare Industry

I. Industry Pain Points and Core Value of the Solution：

In industries with extremely high requirements for compliance and quality control, such as pharmaceuticals, medical devices, and food, enterprises face core challenges including difficult product traceability, complex production process supervision, low cross-department collaboration efficiency, and insufficient data utilization. Addressing these pain points, Hippocrates’s Digital Factory Solution is built on meeting regulatory requirements such as GMP, FDA, and ISO. Through full-process digital management, it enables end-to-end product lifecycle traceability, standardized production processes, and maximum data value realization. This helps enterprises reduce quality risks, improve operational efficiency, and enhance market competitiveness.

II. Panoramic Architecture of the Digital Factory：

(1) Four-Layer Architecture System

1. Equipment Control Layer: Integrates systems and equipment such as SCADA (Supervisory Control and Data Acquisition) systems, DCS (Distributed Control Systems), and AGV/RGV (Automated Guided Vehicles/Rail-Guided Vehicles). It realizes automated control of production equipment and real-time data collection, covering functions like environmental monitoring, energy consumption management, and equipment status monitoring.
2. Business Execution Layer: Comprises core modules including MES (Manufacturing Execution System), WMS (Warehouse Management System), QMS (Quality Management System), and LIMS (Laboratory Information Management System). It covers the entire business process, including production planning, material management, quality control, and warehouse logistics.
3. Monitoring Layer: Through a visual traceability platform, it displays real-time data such as order traceability, manufacturing traceability, material traceability, equipment status, and quality monitoring. This enables management to grasp production and operation status in real time.
4. Business Operation Layer: Centered on the ERP (Enterprise Resource Planning) system, it realizes digital collaboration in business activities such as financial management, procurement management, sales management, and asset management, supporting enterprise strategic decision-making.

(2) Key Functional Modules

1. Production Management: Supports functions such as production planning, work order management, electronic batch records, material balance calculation, and production data early warning. It ensures production processes strictly comply with SOP (Standard Operating Procedures) and reduces human errors.
2. Warehouse and Logistics Management: Achieves full-process material tracking through barcode/RFID tag technology, supporting operations such as warehousing, outbound, transfer, and inventory checking. It adheres to the "first-expire, first-out" principle to optimize inventory management efficiency.
3. Quality Control: Covers the entire process management of sampling, inspection, and release. It integrates data from instruments such as electronic scales, balances, and pH meters, supports deviation handling and quality traceability, and ensures products meet regulatory requirements.
4. Equipment Management: Realizes the full lifecycle management of equipment, including maintenance, repair records, verification of measuring instruments, and operation data collection. It reduces equipment failure risks through a preventive maintenance system.
5. Electronic Batch Records and Audit Trail: Automatically generates electronic batch records, records key production process data, and supports electronic signatures and audit trails. This ensures data integrity and compliance, meeting regulatory requirements.

III. Core Advantages and Technical Highlights

(1) Configurability and Flexibility

The system supports multi-dimensional configuration of modules, pages, buttons, and fields to adapt to the business processes and management needs of different enterprises. For example, it allows customization of electronic batch record templates, configuration of process operation steps and quality control points, enabling rapid adaptation to production requirements of different categories such as chemical pharmaceuticals, biopharmaceuticals, and traditional Chinese medicine (TCM).

(2) Full-Process Digitization and Data Integration

Through a plant-wide network platform, it realizes real-time production data collection and multi-system integration (e.g., MES with ERP, LIMS, WMS). This breaks down information silos. Big data technology is used to analyze production, quality, and equipment data, providing a scientific basis for decision-making and improving the enterprise’s intelligent management level.

(3) Visualization and Intelligent Scheduling

By accumulating, analyzing, screening, and reusing best practices in business operations from outstanding enterprises, Singdi has integrated such expertise into its QMS solution. This enables comprehensive empowerment for customers at different development stages.

(4) Compliance and Validation System

With reference to the V-model validation methodology in FDA 21 CFR Part 11, Hippocrates provides full-lifecycle validation services from requirement research to acceptance. This ensures the system complies with China’s new GMP and international regulatory requirements, reducing compliance risks.

IV. Typical Application Scenarios and Customer Value

(1) Material Management Scenario

Automatic material information identification and error prevention are achieved through code scanning. For example, in the weighing process, the system automatically verifies the consistency between material labels and container labels to prevent confusion. During production, the system tracks material flow in real time, ensuring verifiable material balance and reducing waste.

(2) Quality Traceability Scenario

It provides end-to-end traceability from raw materials to finished products, supporting quick query of production records, inspection data, and equipment operation parameters via batch numbers. When quality issues arise, the problematic link can be quickly identified and recall procedures initiated, reducing recall costs and brand risks.

(3) Cross-Department Collaboration Scenario

It integrates business processes of procurement, production, quality inspection, and warehousing departments. For instance, production plans are automatically synchronized to the warehousing department to trigger material preparation; quality inspection results are fed back to the production department in real time to guide production adjustments, improving cross-department collaboration efficiency.

5. Industry Applications and Customer Cases

Hippocrates’s Digital Factory Solution has been successfully applied in over 100 life sciences and healthcare enterprises, including well-known companies such as Tibet Cheezheng Tibetan Medicine, Zhengda Qingchunbao Pharmaceutical, China Resources Sanjiu Medical & Pharmaceutical, and Shanghai RAAS Blood Products. It covers multiple fields such as chemical pharmaceuticals, biopharmaceuticals, TCM, and medical devices. Through digital transformation, customers have achieved significant results: 20%-30% increase in production efficiency, over 50% reduction in quality error rates, and a significant decrease in compliance management costs.

6. Contact Us

Hippocrates Health Technology is committed to providing professional digital solutions for the life sciences and healthcare industry. For more details or to obtain a customized solution, please feel free to contact us!