Electronic Contract System (eSign) Project of Anling Biomedical (Suzhou) Co., Ltd.

I. Case Overview

Anling Biomedical (Suzhou) Co., Ltd. was established in May 2017 and formed its initial team in July 2018 to officially launch its service operations. As a professional technical service company specializing in new drug safety evaluation, it is mainly committed to services such as biological sample analysis and pathology & toxicology-related experimental technologies. Its core clients include new drug R&D enterprises, generic drug manufacturers, and chemical R&D and production enterprises, for which it provides clinical services covering the fields of chemical drugs, biological products, traditional Chinese medicines, medical devices, cell therapy products, and chemicals.

II. Project Background

To leverage advanced digital technologies to enhance the company’s management capabilities, and ensure the authenticity, reliability, and traceability of data, Anling Biomedical (Suzhou) Co., Ltd. decided to implement the Hippocrates Qiantai Electronic Contract System (eSign) project. The initiative aims to improve the efficiency and security of business processes through digital transformation, while ensuring compliance with industry regulations and market trends.

III. Specific Measures

(1) Overall Planning

Qiantai simplifies the management of the contract lifecycle through automated workflows. It provides functions including organizational management, seal authorization, CA contracts, digital signatures, timestamps, contract verification, real-name/SMS authentication, face verification, corporate address book, electronic document storage, and business intelligence. The entire contract process is fully automated, helping enterprises accelerate business launch, enhance compliance, and improve the workflow experience for employees and customers.

(2) Organizational Management

Enterprises can establish appropriate seal management systems based on their business characteristics and seal usage frequency. The eSign system supports multi-organization and parallel organization management under a group structure, enabling connectivity between organizations at different levels. It facilitates contract sending from enterprise to enterprise and from enterprise to individual, while also supporting organization-level permission management.

(3) Integrated Electronic Signing Solution

The system offers an integrated electronic seal solution combining "electronic signing + data deposit + physical seal control + anti-counterfeiting printing". Through the electronic seal module, various types of seals within an organization can be managed in a centralized and unified manner. The use, maintenance, and authorization of seals are carried out in accordance with the permission settings of organizational personnel, ensuring that the organization’s seals are used safely and efficiently under established management systems, and improving the efficiency and legal compliance of seal usage.

(4) Technical Architecture

The Qiantai® Electronic Contract Management System (eSign) is one of the core modules of the Singdi Aotai Digital Platform. Aotai is a digital platform jointly developed by Singdi’s industry experts and IT specialists, with "quality compliance expert" as its management philosophy and market positioning. It helps enterprises improve quality compliance standards, meet industry supervision requirements, enhance management capabilities, and accelerate the market launch of more safe, effective, and high-quality products.

The applications on the Aotai Platform can be customized to an enterprise’s quality system based on its needs. The built-in configuration tools already cover multiple quality management functions, eliminating the need for customization or programming to implement specific processes. Personnel with proper training can quickly customize forms, decision trees, and dashboards to meet specific business requirements.

The excellent design of the Aotai Platform ensures that users can quickly access large volumes of records and data, thereby improving work efficiency. The "intelligent loading" of forms minimizes loading time, and frequently used data is cached to maximize network bandwidth utilization. Data is stored in an efficient manner, and the distributed architecture is optimized for server expansion. Standard APIs significantly improve system access efficiency, including automatic email notifications, SMS notifications, and dashboard alert integration into workflows, which greatly reduces the risk of missing tasks or approvals. The background task submission and management mode allows users to perform other tasks simultaneously. A standard intermediate service layer is provided to support integration with any third-party system, facilitating data exchange between the Aotai Platform and other application systems.

IV. Construction Achievements

(1) Enterprise Achievements

The implementation of Qiantai by Anling Biomedical has significantly improved the management efficiency of the pharmaceutical enterprise, specifically reflected in the following aspects:

1. Faster Document Processing: Through electronic signatures, pharmaceutical enterprises can quickly complete the approval and signing process of documents, eliminating the need to wait for the printing, delivery, and mailing of paper documents, thus greatly shortening the document processing cycle.
2. Reduced Paper Document Management Costs: The electronic contract system reduces costs related to the printing, storage, and archiving of paper documents, while lowering the risks associated with document loss or damage.
3. Enhanced Compliance and Security: Electronic signatures comply with pharmaceutical industry regulatory requirements, such as FDA’s 21 CFR Part 11, and are supported by CA certificates, ensuring the legal validity of electronic records and data integrity.
4. Optimized Workflows: The electronic contract system is integrated with the Singdi Aotai Platform, which has good scalability and can be integrated into the existing digital system of pharmaceutical enterprises. This enables automated workflows, reduces manual intervention, and lowers error rates.
5. Improved Audit Capabilities: The electronic contract system provides detailed audit trails, recording the time, personnel, and operations of each signature, facilitating inspections by regulatory authorities and internal audits of the enterprise.
6. Support for Remote Work: Electronic signatures allow employees to sign documents from any location, increasing work flexibility.
7. Guaranteed Data Authenticity and Tamper-Proofing: Combined with timestamp services and digital certificates, electronic signatures ensure the authenticity of electronic documents and the non-tamperability of signers’ identities.
8. Promoted Cross-Departmental Collaboration: The electronic contract system breaks down barriers between departments, enabling information sharing and process collaboration, and improving the operational efficiency of the entire organization.
9. Realized Digital Closed-Loop of Business Processes: Through electronic signatures, the full-process digital management from document/contract drafting, approval, signing to archiving can be achieved, forming a business closed-loop.
10. In summary, the electronic contract system greatly improves the management efficiency of pharmaceutical enterprises by enhancing quality and efficiency, and reducing compliance risks.
11. The comparison of economic benefits after the project completion is as follows:[Improvement in Labor Efficiency for Document/Contract Signing and Comprehensive Management]

• Significantly reduced document management costs: Expenses on printing of document/contract records, related consumables, and document storage were reduced by more than 70%.
• Greatly improved work efficiency: The time required for multi-party (especially cross-regional) document signing was reduced by more than 95%.
• Comprehensive improvement in the compliance of document/contract management: The authenticity of data, integrity of documents, and traceability were improved by 100%.

(2) Social Achievements

The social achievements of the electronic contract system mainly include:

1. Guarantee of Pharmaceutical Compliance and Regulatory Compliance: The pharmaceutical industry is subject to strict regulatory supervision. The electronic contract system helps enterprises meet relevant regulatory requirements and ensures the legal validity of electronic records and signatures. Electronic signatures ensure the integrity and security of data during transmission and storage, preventing data tampering or loss. In case of disputes, they enable accurate tracking and verification of document signers and signing times, clarifying legal responsibilities.
2. Cost Reduction and Efficiency Improvement in Enterprise Operations: By automating the signing process, the time and human resources required for traditional paper document processing are reduced, thereby improving overall work efficiency. It also cuts down costs related to the printing, copying, storage, and mailing of paper documents/contracts, while reducing potential costs caused by document loss or damage.
3. Other Social Effects:(1) Strengthened audit trails;(2) Promoted remote work and collaboration;(3) Optimized supply chain management, accelerated the speed of order processing, delivery, and receipt confirmation, and improved the transparency and efficiency of the supply chain;(4) Facilitated digital innovation in the industry, and enhanced service quality and operational efficiency;(5) Better response to emergencies (e.g., ensuring the rapid processing of key business processes during the pandemic).
4. In conclusion, by providing the above-mentioned values, the electronic contract system helps pharmaceutical enterprises improve work efficiency and reduce costs while ensuring compliance, and promotes the application of technologies in the industry. It not only guarantees the compliance of pharmaceutical enterprises’ business management but also achieves significant economic benefits. The case of Anling Biomedical’s implementation of Qiantai provides a new idea for pharmaceutical enterprises on how to enhance their management capabilities through digital technologies.

V. Related Solutions

Solution 1: Pharmacovigilance Solution (PVS)

Solution 2: GMP Quality Compliance Digital Solution (QCMS)

VI. Related Cases

Case 1: Pharmacovigilance Management System (PVS) Project of Beijing Northland Biotechnology Co., Ltd.

Case 2: Pharmacovigilance (PVS) Project of Sinovac Biotech Co., Ltd.

Case 3: GMP Quality Compliance Digitalization (QCMS) Project of Zhejiang Zhenyuan