Digital Transformation at Yichang HEC: Elevating CMC R&D through Comprehensive Digital Solutions

About Yichang HEC

Founded on August 8, 2001, Yichang HEC is a leading Chinese pharmaceutical company specializing in the development, manufacturing, and sale of pharmaceutical products in therapeutic areas such as antiviral, endocrine, metabolic, and cardiovascular diseases. HEC currently manufactures, markets, and sells 33 pharmaceutical products across China, supported by an extensive domestic distribution network.

 

 

Background
Yichang HEC’s digital laboratory initiative was implemented in its generic drug CMC R&D laboratory, with a primary focus on formulation and quality research. The scope includes preparation technology, formulation development, impurity analysis, quality control, and stability studies.

 

Goals & Objectives

  • Enhance project management capabilities: Enable real-time progress tracking and optimize project resource allocation.
  • Standardize experimental documentation: Ensure standardized recording of processes, results, and data, making it easier for researchers to retrieve relevant information.
  • Implement lifecycle management of experimental materials: Manage material storage, receipt, inventory, and ledgers for improved research support.
  • Automate data acquisition and analysis: Reduce manual errors and improve research efficiency, while maximizing paperless operations during analysis and inspection.
  • Ensure compliance: The system must strictly adhere to cGMP, FDA 21CFR Part 11, and GAMP5 standards, ensuring data auditability and secure electronic records.
  • Establish robust permission management: Implement a hierarchical authorization system to ensure data security.
  • Facilitate information sharing: Break down data silos and enable seamless information flow across the organization.

 

Our Solutions
Neotrident provided Yichang HEC with a comprehensive CMC digital management platform that spans the entire workflow during the CMC stage. The solution incorporates multiple modules, including Project Management (PM), Electronic Lab Notebooks (ELN), Instrument Management (IM), Material Management (MM), Stability Study Management (SM), and Sample Inspection Process Management (SIP), all integrated in an unified iLabPower platform.

 

Results & Benefits

Project Management

  • Project leaders gain an intuitive overview of project status, enabling more informed decision-making and task prioritization.
  • The project management department can easily track project progress and identify potential issues early on.
  • Project documents are archived digitally, enhancing data security and making electronic storage more convenient.

Material Management

  • Easy access to the physical and chemical properties of reagents, toxicological data, and safety information.
  • Inventory searches and chemical claiming processes are streamlined online, reducing communication costs.
  • Shortened claiming time, with improved traceability for chemical usage, supported by E-signatures.
  • Warehouse efficiency improved by preparing materials in advance based on online requests, reducing errors.
  • Automated inventory updates provide a more accurate and intuitive overview of stock levels.

Electronic Lab Notebooks (ELN)

  • Experimental record efficiency and standardization improved through pre-built templates and workflows.
  • Real-time electronic time-stamped records prevent falsification, improving the accuracy of original data.
  • Backup schemes for electronically stored data ensure long-term security.
  • Fast PDF parsing and data extraction significantly enhance the efficiency and accuracy of quality research experiments.

Stability Studies

  • Automated reminders prompt stability managers to place and retrieve samples according to study plans, preventing omissions.
  • Stability plans are managed online and generated automatically, with real-time tracking of placing and retrieving records.
  • Samples are sent for inspection and analysis with results automatically returned to the system, providing quick access to data.
  • The system allows flexible adjustments to the stability plan during execution, enabling quick changes to testing intervals or analysis items.

Instrument Management

  • Scientists can monitor the status of instruments online, ensuring better resource allocation.
  • Instrument reservations are managed to improve availability and utilization.
  • A mobile app with QR code functionality simplifies instrument usage, with automated ledger recording.

Instrument calibration and maintenance schedules are managed online, with reminders sent to users as needed.

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