PRODUCT & SOLUTION
Product & Solution
Focusing on digital quality system management, we meet regulatory requirements and build a digital operation platform that fully supports GxP business processes. Hippocrates quality compliance suite includes document management system (DMS), training management system (TMS), quality management system (QMS), pharmacovigilance management system (PVS) and electronic contract management system (e-Sign).


Hippocrates Health Technology Virtual Data Room (VDR): The Professional Choice for Life Sciences Data Sharing


I. Core Advantages of VDR: Safety, Efficiency, and Compliance

(I) Strong Security Assurance

Hippocrates VDR stores documents in highly secure data centers, equipped with multiple security protection measures. It can impose strict restrictions on user operations such as file access and printing; even if a user has opened a file, access permissions can be revoked at any time. Meanwhile, it can accurately track and record all user operations within the data room, and support the application of personalized watermarks and customized Non-Disclosure Agreements (NDAs). This achieves comprehensive protection of files, eliminating the risks of data replication, misuse, and leakage—an advantage that other online sharing tools can hardly match.

(II) Significant Efficiency Improvement and Cost Reduction

VDR enables users to access data via secure encrypted networks from any location, facilitating efficient sharing and collaboration to accelerate transaction closure. It features user-friendly operations: team members or partners can be added with one click, users can access multiple files simultaneously, and upload/download of multiple files and folders can be completed via drag-and-drop. Additionally, users can set time limits for file access. Moreover, using VDR reduces unnecessary business trips, delays from document couriers, and expenses on expensive printing services. It enhances platform efficiency, shortens transaction cycles, and significantly cuts down enterprises’ time and monetary costs.

(III) High Compliance

VDR is fully compliant with regulatory requirements of NMPA, FDA, EMA, etc., and is closely integrated with the Document Management System (DMS). Files in DMS can be directly dragged and dropped into VDR for real-time sharing. The platform is equipped with powerful functions to simplify user workflows: it supports tracking how suppliers view documents, its built-in search function optimizes file retrieval time, and users receive real-time SMS notifications when new content is added. This provides life sciences enterprises with a compliant and convenient solution.


II. Functional Features of VDR: Fully Meeting Business Needs

(I) File Management and Permission Control

VDR provides a clear directory and file management system, supporting electronic file management for quick and easy file retrieval. It enforces strict permission control, covering multiple permission types such as viewing, downloading, revising, approving, and managing. Clear permission divisions are set for different user groups, ensuring the security and standardization of file access.

(II) Watermark Protection and Operation Logging

It is equipped with robust watermark protection functions, including real-time watermarks (anti-screenshot), effective-time watermarks, and file-controlled watermarks, which effectively protect confidential core files. At the same time, it records all operations within VDR in real time, with detailed information such as user identity, operation type, and time—providing strong support for auditing and management.

(III) Mobile Access and Audit Management

VDR supports mobile access: users can conveniently log in to the platform via mobile devices such as smartphones to select directories, view documents, and perform other operations, meeting the needs of mobile work. In terms of audit management, VDR can prepare audit materials in advance to realize clear display of directories and files; during on-site audits, more materials can be imported in real time as required by auditors; auditors can only access authorized materials—ensuring the compliance and security of the audit process. This effectively addresses pain points such as time-consuming organization of audit files, difficulty in retrieval, difficulty in verifying signature records, delayed file version updates, and easy loss of confidential files.


III. Kuntai® Digital Quality Management System (QMS): Synergistically Empowering Enterprise Development

In addition to VDR, Hippocrates Health Technology has also launched the Kuntai® Digital Quality Management System (QMS). It forms a synergistic effect with VDR to further enhance enterprises’ quality management and operational efficiency.

(I) Document Management

Integrated with CA electronic signatures, it realizes full-lifecycle document management. It supports offline printing, barcode scanning, and has built-in functions such as GMP processes, eight-level permissions, and electronic approval—ensuring the standardization and security of document management.

(II) Training Management

It provides comprehensive online training and courseware management, covering functions such as course planning, courseware management, question bank management, certificate management, and learning reminders. It also supports mobile learning to help enterprises improve employee competence.

(III) Management of Deviations, CAPA, Changes, Audits, and Complaints

  • Deviation Management: Integrates essence of excellent management, aligns with the management needs of Chinese enterprises, and realizes process automation and task reminders.
  • CAPA Management: Supports multiple incident sources to ensure the executability of CAPA.
  • Change Management: Supports changes in business, production, projects, and other aspects, realizing process automation and risk assessment.
  • Audit Management: Supports internal and external audit processes, enables automatic task assignment, and tracks audit findings.
  • Complaint Management: Supports internal and external complaints regarding products, processes, services, etc., integrates with CAPA, and complies with relevant regulatory requirements.


IV. Application Scenarios and Value

Hippocrates VDR is applicable to scenarios such as product R&D, collaborative work, and capital operations of life sciences enterprises. Under the strict requirements of governments and regulatory authorities for patient data protection, it helps enterprises optimize data communication and external sharing methods, protect core corporate information, and realize easy sharing, control, and tracking of data. Kuntai® QMS fully supports enterprises’ quality management and enhances their compliance and operational efficiency.

As a leader in digital solutions for the life sciences industry, Hippocrates Health Technology is committed to providing professional and reliable products and services for enterprises. For detailed solutions, please contact the team of Shanghai Hippocrates Health Technology.