With increasingly stringent GLP regulations both domestically and internationally, toxicology and safety evaluation laboratories are accelerating their transition from "paper-based records" to "digital compliance." Sunwayworld's SW-GLPLIMS integrated platform, leveraging a unified data model and end-to-end process control, effectively helps laboratories balance compliance, efficiency, and cost. It has become a high-quality domestic solution capable of replacing foreign GLP systems.
 
I. Limitations of Foreign GLP Systems in the Chinese Market
 
The core of a GLP system is the controlled and traceable lifecycle management of toxicology studies: from study initiation, protocol and tasks, animals and specimens, raw data entry and instrument acquisition, data review and QA audits, to data statistics and report management. Each stage must comply with regulatory requirements such as ALCOA+, electronic signatures, and audit trails. Due to differences in regulations and laboratory software/hardware environments between China and other countries, although foreign GLP systems are professional, they face the following challenges when implemented in China:
 
1. Dual Compliance Requirements. Besides international standards, they must also meet Chinese GLP regulations and Xinchuang security standards, which foreign systems struggle to accommodate simultaneously.
 
2. Mismatched Deployment Models. Foreign systems often use subscription-based cloud services, while domestic laboratories prefer private deployment or perpetual licenses to ensure data security and budget control.
 
3. Functionality Focused on Results, Neglecting Process. Foreign systems emphasize experimental result recording with simple interfaces; whereas domestic laboratories require comprehensive process management, including animal management from procurement to acclimation, Chinese terminology libraries, and local report formats, which foreign systems find difficult to support.
 
4. Insufficient Configuration Flexibility. Relying solely on configuration cannot meet the diverse management needs in China, leading to continued dependence on paper records for many steps.
 
Surveys indicate that foreign systems can only meet about 50% of the needs of domestic laboratories, with the remainder relying on manual operations, coupled with high subscription costs.
 
II. Development History of SW-GLPLIMS
 
2003 - 2013: Built the core LIMS and ELN platform, supporting sample management, task workflow, and audit trails, compliant with international regulations.
2014 - 2021: Integrated quality system management, covering documents, training, CNAS, and QMS, enhancing process compliance. Released SW-GLPLIMS V12.0.
2021 - 2023: Achieved full-process digitalization for GLP, covering various study types like general toxicology and genetic toxicology, supporting lifecycle management from study initiation to archiving.
2023 - Present: The domestic replacement version of GLP is widely used in various domestic industries including medical devices, cosmetics, health products, pesticides, and new drug研发 (R&D). Adapted for multi-language, multi-timezone, and domestic system compatibility, fully meeting Xinchuang requirements.
 
III. Core Advantages of SW-GLPLIMS
 
1. Compliance Assurance. Built-in ALCOA+ verification, adherence to OECD GLP, NMPA, and other domestic and international regulations. Provides complete CSV validation documentation to facilitate efficient audit preparation.
 
2. Comprehensive Functionality. Covers all functionalities of foreign systems while strengthening process management, such as full animal lifecycle management, better aligning with the needs of Chinese laboratories, enabling import substitution.
 
3. Flexible and Extensible. Supports low-code configuration, allowing trained users to adjust functions themselves, enabling quick response to business changes.
 
4. Integrated Architecture. Driven by a triple core of "Research Study + Compliance + Data," enabling seamless integration of multiple systems like LIMS/ELN/QMS.
 
5. Advanced Technology. Based on JAVA and B/S architecture, no client installation required, supports cross-platform deployment.
 
6. Multi-language Support. Interface can be switched to languages familiar to auditors, improving audit communication efficiency.
 
IV. Market Prospects
 
Driven by both policy guidance and industrial upgrading, GLP digitalization is gradually becoming a "new productive force" for laboratories. SW-GLPLIMS comes with a built-in rich library of toxicology study methods. Leveraging Sunwayworld's extensive experience in implementing solutions for toxicology laboratories, it can effectively reduce implementation and validation costs, accelerate system deployment, improve audit pass rates, and ensure cross-batch data consistency. The system is widely applicable in various industries such as pharmaceuticals, medical devices, cosmetics, health products, pesticides, and new materials. Furthermore, with its multi-language and cross-regional capabilities, SW-GLPLIMS strongly supports the new digital paradigm of "R&D in China, Delivery to the Globe."