Suzhou ImmunoGene Warehouse Management System (WMS) Project

I. Customer Background

Suzhou ImmunoGene Biopharmaceutical Co., Ltd. (hereinafter referred to as "ImmunoGene") is an innovative biopharmaceutical enterprise focusing on the R&D and manufacturing of cell therapy drugs, located in Suzhou Industrial Park. Its core business covers leukapheresis collection and receiving, cryopreserved leukapheresis intermediate management, and product release-to-bag. Characterized by highly individualized products, rigorous batch control and full-chain low-temperature storage & transportation, the company imposes extremely stringent requirements on warehouse management, quality control and end-to-end traceability of materials and products.

II. Business Challenges

The unique attributes of cell therapy products mean their warehouse management cannot adopt conventional pharmaceutical practices:

1. Demanding storage conditions: Materials, finished products and samples require cryogenic storage such as liquid nitrogen, calling for refined location and shelf-life management.
2. High traceability requirements: Products must implement "one unique code per item, one unique code per batch" with exclusive traceability identifiers to support full-lifecycle traceability from leukapheresis receipt to finished product infusion.
3. Closed-loop quality control: Quality activities including sampling, testing and release need seamless alignment with warehouse operations, with finished products subject to release-to-bag control.
4. Mix-up and error prevention: Parallel handling of multiple batches, suppliers and storage conditions requires effective controls to prevent mix-ups, errors and cross-contamination.
5. Regulatory compliance pressure: The system must fully comply with GMP requirements, with built-in data integrity capabilities such as electronic records, electronic signatures, audit trails and role-based access control.

Meanwhile, the enterprise’s existing ERP, MES, LIMS and end-to-end traceability systems (COI & COC) need seamless integration with warehouse operations. Traditional warehouse management approaches can no longer meet the comprehensive demands for refinement, digitalization and compliance amid the company’s commercialization journey.

III. Solution

Tailored to ImmunoGene’s warehouse characteristics and compliance requirements, Singerdi delivered an integrated solution covering software licensing + mobile operations + system integration + on-premises deployment:

• WMS Software Licensing: Core modules include master data management, warehouse configuration, inbound/outbound, in-warehouse handling, inventory counting, statistical inquiry for raw/excipient materials, packaging materials and finished goods; quality management for sampling, testing and release; as well as user administration, access control, audit trails, system administration and barcode management. Unlimited user licenses and warehouse capacity support flexible management across multiple warehouses, roles and workflows.
• Mobile APP: Supports mobile operations such as receiving, issuing and inquiry to enable real-time on-site warehouse execution.
• Multi-system Interface Integration: Full integration with MES, LIMS, COI, COC and ERP, enabling data exchange for warehouse documents, master data and task dispatching. Barcodes are mutually recognized between warehouse, workshop and traceability systems to unify warehouse data with production, quality, finance and end-to-end traceability workflows.
• On-premises Deployment: Meets enterprise requirements for data security and independent control.

(1) CSV Computerized System Validation

The project adopted a parallel delivery model for system implementation and CSV validation. Following a risk-based validation approach built on the GAMP5 V-model, it delivers a complete set of standard CSV deliverables including Infrastructure Risk Assessment (IRA), User Requirements Specification (URS), Validation Plan (VP), Risk Assessment (RA), Requirement Traceability Matrix (RTM), Design Qualification (DQ), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Standard Operating Procedures (SOP), Production Installation Qualification (pIQ), Performance Qualification (PQ) and Validation Summary Report (VSR). Special compliance design and risk closure were performed for high-risk modules such as warehouse operations, quality management and system integration. This ensures electronic records, electronic signatures, audit trails and role-based access control fully satisfy GMP inspection expectations, establishing a complete, traceable and auditable compliance evidence package.

(2) Implementation Roadmap

The project was delivered by Singerdi’s GMP Intelligent Manufacturing Division, with CSV validation services provided by Singerdi’s GMP Consulting Division. The two teams collaborated closely under the integrated model of system implementation + compliance validation, enabling seamless alignment between project build and compliance setup. Clear milestones were defined across four phases: Project Investigation & Business Blueprint Design → System Configuration & Testing → WMS Trial Operation → Validation & Go-Live, ensuring synchronized delivery of system deployment and compliance validation. After launch, Singerdi provides long-term maintenance services with tiered response mechanisms to sustain stable and compliant system operation.

IV. Project Value

1. Full digitalization of warehouse operations: Inbound, outbound, in-warehouse activities, inventory counting and reporting are fully digitized. Barcode technology paired with mobile APP operations greatly improves operational efficiency and accuracy.
2. Closed-loop quality management: Sampling, testing and release are deeply embedded into warehouse workflows. Automatic status routing for release decisions and batch status updates prevent accidental consumption of unreleased materials at the source.
3. End-to-end full-lifecycle traceability: Deep integration with MES, LIMS, COI, COC and ERP enables unique-code traceability spanning from leukapheresis receipt to finished product infusion.
4. One-stop compliance framework: CSV validation runs in parallel with system construction, with validation deliverables delivered alongside the system. This lays a solid foundation for the enterprise to cope with routine GMP regulatory inspections.

This collaboration serves as a typical case of warehouse digitalization and compliance development for cell therapy enterprises. Going forward, Singerdi will continue to deliver standardized, practical compliance validation and digital solutions to help more life science enterprises achieve dual upgrades in digital transformation and compliance systems.