Zhongke Zhongshan Institute for Drug Discovery and Innovation Electronic Contract System (eSign) Project

I. Case Overview

Zhongke Zhongshan Institute for Drug Discovery and Innovation (hereinafter referred to as "Zhongshan Institute for Drug Innovation, ZSIDI") is a new-type R&D institution jointly established by the People's Government of Zhongshan City and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. Located in Cuiheng New District, Zhongshan City, Guangdong Province, the institute was founded in September 2018 to advance the national strategy for the Guangdong-Hong Kong-Macao Greater Bay Area and promote the innovative development of Zhongshan's biomedical industry.

As a comprehensive pharmaceutical research institution, ZSIDI integrates biomedical research, high-level talent cultivation, and the industrialization of scientific research achievements. It is committed to building an internationally advanced drug R&D center, focusing on innovative drug research and development, technological breakthroughs, platform construction and services, biomedical industry incubation, and talent development. As the first scientific research-oriented provincial-level public institution in Zhongshan, ZSIDI has obtained a number of honors and qualifications, including the Postdoctoral Research Station and Guangdong Provincial High-Level Innovation Institute.

In terms of scientific research, ZSIDI has established multiple leading talent teams and carried out joint postgraduate training programs in collaboration with several universities. By April 2024, the institute had published nearly 300 papers, secured over 120 funded research projects, and filed more than 45 invention patents. Meanwhile, it actively participates in international academic exchanges to promote the transformation and application of scientific research results.

II. Project Background

With the widespread application of digital technology in the pharmaceutical R&D field, electronic documents and electronic signatures have become increasingly important in clinical trial document management. However, issues such as the ease of forgery and loss of electronic signatures pose challenges to compliance and security. To address this, ZSIDI implemented the Hippocrates Qiantai® SignTrust® Electronic Contract System (eSign), shifting the document signing method from offline to online and replacing paper-based signing with electronic signatures.

The implementation of this project avoids the problems of slow speed and low efficiency associated with the offline transmission of paper documents. It not only improves efficiency but also ensures the compliance and validity of documents, playing a crucial role in advancing digital development.

III. Specific Measures

(I) Overall Planning

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

(II) 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 across different organizational levels. It allows contracts to be sent from enterprise to enterprise and from enterprise to individual, while also supporting organization-level permission management.

(III) 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 centrally managed. The use, maintenance, and authorization of seals are carried out in accordance with personnel permissions, ensuring that the organization's seals are used safely and efficiently in line with established management systems, thereby improving the efficiency and legal compliance of seal usage.

(IV) Technical Architecture

The Qiantai® Electronic Contract Management System (eSign) is one of the core modules of the Singdi Aotai Digital Platform. Developed jointly by Singdi's industry experts and IT specialists, the Aotai Platform adopts the management concept and market positioning of "Quality and Compliance Expert". It helps enterprises improve quality and compliance standards, meet industry supervision requirements, enhance enterprise management capabilities, and accelerate the launch of more safe, effective, and high-quality products.

Applications on the Aotai Platform can be customized to meet enterprises' needs for quality management systems. The built-in configuration tools already include multiple quality management functions, eliminating the need for customization or programming to implement specific processes. Trained personnel can quickly customize forms, decision trees, and dashboards to meet specific business requirements.

The superior 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, while frequently used data is cached to maximize network bandwidth utilization. Data is stored in an effective 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 alerts integrated into workflows—greatly reducing 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

(I) Enterprise Achievements

The implementation of Qiantai by ZSIDI has significantly improved the management efficiency of pharmaceutical enterprises, specifically reflected in the following aspects:

1. Faster Document Processing: Electronic signatures enable pharmaceutical enterprises to quickly complete the approval and signing 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 (e.g., FDA’s 21 CFR Part 11) and 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 excellent scalability. It can be integrated into the existing digital systems of pharmaceutical enterprises to realize automated workflows, reduce manual intervention, and lower 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 enterprises.
6. Support for Remote Work: Electronic signatures allow employees to sign documents from any location, increasing work flexibility.
7. Guaranteed Data Authenticity and Tamper-Resistance: 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 inter-departmental barriers, enabling information sharing and process collaboration to improve the operational efficiency of the entire organization.
9. Realized Digital Closed-Loop for Business Processes: Through electronic signatures, end-to-end digital management—from document/contract drafting, approval, and signing to archiving—is 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 Efficiency of Document/Contract Signing and Comprehensive Management】

• Significantly reduced document management costs: Expenses for document/contract record printing, related consumables, and document storage were reduced by over 70%.
• Greatly improved work efficiency: Time required for multi-party (especially cross-regional) document signing was reduced by over 95%.
• Comprehensive improvement in document/contract management compliance: Data authenticity, document integrity, and traceability were improved by 100%.

(II) 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 ensure 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 for Enterprise Operations: Automated signing processes reduce the time and human resources required for traditional paper document processing, thereby improving overall work efficiency. They also cut 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 Impacts: (1) Strengthened audit trails; (2) Promoted remote work and collaboration; (3) Optimized supply chain management by accelerating the speed of order processing, shipment, and receipt confirmation, and improving the transparency and efficiency of the supply chain; (4) Advanced digital innovation in the industry, enhancing service quality and operational efficiency; (5) Better response to emergencies (e.g., ensuring the rapid processing of key business processes during pandemics).
4. In conclusion, by delivering the above value, the electronic contract system helps pharmaceutical enterprises improve work efficiency and reduce costs while ensuring compliance, and promotes the application of technology in the industry. It not only guarantees the compliance of pharmaceutical enterprise business management but also achieves significant economic benefits. The case of ZSIDI implementing Qiantai provides a new idea for pharmaceutical enterprises on how to improve their management level through digital technology.

V. Associated Solutions

Solution 1: GMP Quality and Compliance Digital Solution (QCMS)

Solution 2: Pharmaceutical Enterprise Contract Manufacturing Quality Management Collaboration Solution (OWL MAH)

VI. Associated Cases

Case 1: Zhejiang Zhenyuan GMP Quality and Compliance Digitalization (QCMS) Project

Case 2: Kobayashi Pharmaceutical Contract Manufacturing Quality Management Collaboration (OWL MAH) Project