Electronic Contract System (eSign) Project of Shanghai Institute of Materia Medica, Chinese Academy of Sciences

I. Case Overview

Shanghai Institute of Materia Medica, Chinese Academy of Sciences (referred to as "SIMM") was founded in 1932. It is the oldest comprehensive innovative drug research institution in China. Its predecessor was the Institute of Materia Medica, National Academy of Peiping. After several renamings and relocations, it finally moved to Zhangjiang High-Tech Park in Pudong, Shanghai in 2003. SIMM focuses on basic research, applied basic research, and application development research of new drugs, particularly in the R&D of new drugs for malignant tumors, cardiovascular and cerebrovascular diseases, neuropsychiatric diseases, metabolic diseases, autoimmune diseases, and infectious diseases. Through close collaboration between the two disciplines of biology and chemistry, the institute clarifies the structure, activity, and interrelationships of bioactive substances, explores new mechanisms of action and new targets for drugs, and completes preclinical comprehensive evaluation and research of new drugs.

II. Project Background

To leverage advanced digital technologies to improve the institute’s management capabilities, and ensure the authenticity, reliability, and traceability of data, SIMM implemented the Singdi SignTrust® Electronic Contract System (eSign). This system shifts the document signing method from offline to online, replacing paper-based signatures with electronic signatures. The implementation of this project addresses the pain points of slow speed and low efficiency associated with offline transmission of paper documents, effectively improving the efficiency of document signing at SIMM, while better meeting the compliance requirements of the industry.

III. Specific Measures

(I) Overall Planning

SignTrust 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, facial recognition for identity verification, enterprise address books, electronic document storage, business intelligence, and other functions. Full automation is achieved throughout the contract process, helping the institute accelerate business operations, enhance compliance, and improve workflow experiences for employees and partners.

(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 one enterprise to another and from an enterprise to an individual, while also supporting permission management at the organizational level.

(III) Integrated Electronic Contract Signing Solution

The system provides an integrated electronic seal solution combining "electronic contract signing + data depositing + physical seal control + anti-counterfeiting printing". Through the electronic seal module, various types of seals within the organization can be centrally managed. 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 in line with established management systems, and improving the efficiency and legal compliance of seal usage.

(IV) Technical Architecture

The SignTrust® 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 experts. 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 launch of more safe, effective, and high-quality products.

Applications on the Aotai Platform can be customized to meet the enterprise’s quality system needs. 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 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; 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 Aotai and other application systems.

IV. Construction Achievements

(I) Enterprise Achievements

The implementation of SignTrust at SIMM has significantly improved the management efficiency of this pharmaceutical research institution, with specific performances in the following aspects:

1. Accelerated document processing: Electronic signatures enable the institution 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 of document loss or damage.
3. Enhanced compliance and security: Electronic signatures comply with the regulatory requirements of the pharmaceutical industry (e.g., 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 the pharmaceutical institution. 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 reviews by regulatory authorities and internal audits of the institution.
6. Enabled remote work: Electronic signatures allow employees to sign documents from any location, increasing work flexibility.
7. Ensured data authenticity and non-tampering: 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, enables information sharing and process collaboration, and improves the operational efficiency of the entire organization.
9. Realized a 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 institutions by enhancing quality and efficiency, and reducing compliance risks.
11. The comparison of economic benefits after the project is as follows:【Improvement in Labor Efficiency for Document/Contract Signing and Comprehensive Management】

• Significantly reduced document management costs: Expenses for printing documents/contract records, related consumables, and document storage were reduced by more than 70%.
• Greatly improved work efficiency: Time required for multi-party (especially cross-regional) document signing was reduced by more than 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 the following:

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 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 reduce costs for printing, copying, storing, and mailing paper documents/contracts, while lowering 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—accelerating the speed of order processing, shipment, and receipt confirmation, and improving the transparency and efficiency of the supply chain; (4) Promoted 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 public health emergencies such as the pandemic).
4. By delivering the above value, the electronic contract system helps pharmaceutical enterprises improve work efficiency, reduce costs, and promote the application of technologies in the industry while ensuring compliance. It not only guarantees the compliance of pharmaceutical enterprise business management but also achieves significant economic benefits. The case of SIMM’s implementation of SignTrust provides a new idea for pharmaceutical enterprises on how to use digital technologies to improve their management capabilities.

V. Related Solutions

• Solution 1: GMP Quality Compliance Digital Solution (QCMS)
• Solution 2: Pharmaceutical Enterprise Contract Manufacturing Quality Management Collaboration Solution (OWL MAH)

VI. Related Cases

• Case 1: GMP Quality Compliance Digitalization (QCMS) Project of Zhejiang Zhenyuan
• Case 2: Contract Manufacturing Quality Management Collaboration (OWL MAH) Project of Kobayashi Pharmaceutical