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CASE STUDY
Case study
Quality is the lifeline of life sciences companies, and more and more companies are implementing professional GMP digital systems to prevent and avoid quality and safety incidents. Since establishment, Hippocrates has provided digital solutions and professional services to more than 200 companies and institutions, avoiding problems that cause quality and safety accidents.
HIPPOCRATES

Taihetai Electronic Contract System (e-Sign) Project



I. Case Overview

Founded in September 2015, Taihetai (Shanghai) Law Firm is a large-scale comprehensive law firm that covers China and connects to the world. Its core business areas and services encompass multiple dimensions:

  • Firstly, it deeply engages in the digital economy sector, providing legal service products related to new business formats such as digital economy compliance, antitrust, algorithm governance, and intelligent technology investment and financing.
  • Secondly, its service scope is extensive, covering corporate business, financial services, securities business, real estate business, mergers and acquisitions, cross-border investment, international trade, intellectual property, litigation and arbitration, government legal services, and more.
  • With high reputation and influence in the industry, the firm offers a broad range of legal services to meet the needs of different clients.


II. Project Background

To leverage advanced digital technologies to enhance corporate management, and ensure the authenticity, reliability, and traceability of data, Taihetai implemented the Hippocrates Qiantai® SignTrust® Electronic Contract System (e-Sign). This system shifts document signing from offline to online, replacing paper-based signing with electronic signatures.

The implementation of this project addresses the pain points of slow speed and low efficiency caused by offline transmission of paper documents, significantly improving Taihetai’s document signing process while better meeting the compliance requirements of the industry.


III. Specific Measures

(I) 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 books, electronic document storage, and business intelligence.

Full automation is achieved throughout the contract process, helping enterprises accelerate business launch, improve compliance, and enhance the workflow experience for employees and clients.

(II) Organizational Management

Enterprises can establish appropriate seal management systems based on their business characteristics and seal usage frequency. The e-Sign system supports multi-organization and parallel organization management under a group structure, enabling connectivity across different organizational levels. It facilitates contract sending from enterprise to enterprise and from enterprise to individual, while also supporting organizational-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 conducted in accordance with staff permissions, ensuring that organizational seals are used safely and efficiently under established management systems, and improving the efficiency and legal compliance of organizational seal usage.

(IV) Technical Architecture

The Qiantai® Electronic Contract Management System (e-Sign) is one of the core modules on 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, 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 into tailor-made quality systems based on enterprise needs. Its 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 fast access to large-volume records and data, thereby improving work efficiency:

  • "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. Project Outcomes

(I) Enterprise Outcomes

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

  1. Faster Document Processing: Electronic signatures enable pharmaceutical enterprises to quickly complete document approval and signing processes, eliminating the need to wait for printing, delivery, and mailing of paper documents—thus greatly shortening the document processing cycle.
  2. Reduced Paper Document Management Costs: The electronic contract system cuts costs related to printing, storage, and archiving of paper documents, while reducing 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 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 reviews 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-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 inter-departmental barriers, enabling information sharing and process collaboration to improve the operational efficiency of the entire organization.
  9. Realized Digital Closed-Loop of Business Processes: Electronic signatures enable end-to-end digital management from document/contract drafting, approval, and signing to archiving, 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 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: Time 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 Outcomes

The social outcomes 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 guarantee 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: 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 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: Accelerated the speed of order processing, shipment, and receipt confirmation, and improved the transparency and efficiency of the supply chain;(4) Promoted digital innovation in the industry: Enhanced service quality and operational efficiency;(5) Better response to emergencies: Ensured the rapid processing of key business processes in emergency situations (e.g., during the pandemic).
  4. In conclusion, by delivering the above value, the electronic contract system helps pharmaceutical enterprises improve work efficiency, reduce costs, and promote the application of industry technologies while ensuring compliance. It not only guarantees the compliance of pharmaceutical enterprise business management but also achieves high economic benefits. Taihetai’s case of implementing Qiantai provides a new idea for pharmaceutical enterprises on how to use digital technologies to enhance corporate management.


V. Associated Solutions

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


VI. Associated Cases

  • Case 1: Boji Pharmaceutical Technology Co., Ltd.
  • Case 2: Drug Safety Evaluation Center of Shanghai Institute of Materia Medica, Chinese Academy of Sciences
  • Client 3: Dingkang (Wuhan) Biomedical Co., Ltd.