Nanjing Aisuo Pharmaceutical Electronic Contract System (eSign) Project
I. Aisuo Pharmaceutical: Leading Innovation
Founded in 2010 in Nanjing, Jiangsu Province, Nanjing Aisuo Pharmaceutical Technology Co., Ltd. is a high-tech enterprise dedicated to the research, development, and production of innovative drugs. Leveraging advanced R&D platforms and cutting-edge technologies, the company aims to deliver high-quality therapeutic solutions to patients worldwide. Guided by the philosophy of "Innovation-Driven, Quality-Oriented, and Customer-Centric," Aisuo Pharmaceutical has established itself as a key player in drug development for oncology, cardiovascular diseases, and neurological disorders.
II. Industry Challenges: The Limitations of Traditional Paper-Based Processes
As regulatory requirements in the pharmaceutical industry grow increasingly stringent, traditional paper-based document signing methods have posed significant challenges. Aisuo Pharmaceutical encountered numerous drawbacks, including:
- Lengthy Processes: Drafting, reviewing, printing, delivering, and signing documents manually took days or even weeks, hampering R&D and production efficiency.
- High Risks: Paper documents were prone to loss, damage, and delays in transmission, threatening critical operations.
- Substantial Costs: Annual expenses for paper storage and management exceeded hundreds of thousands of yuan, with additional costs for office space and labor.
- Inefficient Data Management: Retrieving and tracing information from physical files was time-consuming and risky during regulatory audits.
III. eSign Arrives: A Paradigm Shift
A. Project Planning: Phased Implementation
Aisuo Pharmaceutical adopted the Singhdi SignTrust® Electronic Contract Management System (eSign) to drive digital transformation in two stages:
- Phase 1: Building a foundational eSign system for core functions (contract signing, approval, and storage) across R&D, production, and quality control departments.
- Phase 2: Enhancing system integration with existing IT infrastructure (e.g., ERP and R&D management systems) to streamline workflows and data sharing.
B. Key Features: Empowering Efficiency and Compliance
- Full Lifecycle Management: Automation of contract workflows, from organization management and seal authorization to digital signatures, timestamps, and document archiving, ensuring speed, compliance, and user convenience.
- Multi-Organization & 权限 Control: Support for hierarchical organizational structures, secure cross-entity contract distribution, and granular permissions to safeguard 印章使用安全.
- Integrated Signing Solutions: A unified approach combining "electronic signing + data forensics + physical seal control + anti-counterfeit printing" to centralize 印章 management and ensure regulatory compliance.
C. Technological Backbone
As a core module of the Singhdi OwlTrust® Digital Platform, eSign is supported by:
- Customization: Tailored functionalities to meet Aisuo Pharmaceutical’s unique business needs.
- Scalable Architecture: Distributed storage and standardized middleware enable seamless integration with third-party systems (e.g., ERP) and rapid data access.
- Regulatory Compliance: Alignment with global standards like FDA 21 CFR Part 11 and EU Annex 11, ensuring audit readiness and data integrity.
IV. Transformative Outcomes
A. Corporate Benefits
- Speed: Document processing cycles reduced by over 80%, enabling critical decisions in hours instead of weeks.
- Cost Savings: 70% reduction in paper-related expenses, eliminating storage and retrieval costs.
- Compliance & Security: Digital signatures and timestamps meet strict regulatory requirements, ensuring tamper-proof records and audit trails.
- Process Optimization: Integration with existing systems minimized errors and manual intervention, enhancing operational efficiency.
B. Social Impact
- Industry Benchmarking: eSign set a standard for pharmaceutical compliance, assisting peers in meeting regulatory demands and improving audit efficiency.
- Sustainability: Reduced paper usage and resource consumption aligned with global sustainability goals.
- Adaptability: Facilitated remote collaboration and supply chain optimization, particularly during crises like the COVID-19 pandemic.
V. Future Outlook
The successful implementation of eSign at Aisuo Pharmaceutical demonstrates the power of digital transformation in modernizing traditional industries. As more pharmaceutical companies embrace innovative technologies, eSign will continue to serve as a catalyst for efficiency, compliance, and smart growth. The industry’s future lies in leveraging such tools to accelerate drug development and improve global healthcare.
VI. Related Solutions
- GMP Quality Compliance Digital Solution (QMS)
- Pharmaceutical Outsourcing Quality Management Collaborative Solution (OWL MAH)
VII. Related Cases
- Dingkang Biotech eSign Project
- Taihe Tai eSign Project
