About Yichang HEC
Yichang HEC was found on August 8th, 2001, which is a Chinese pharmaceutical manufacturing company that focuses on the development, manufacturing and sale of pharmaceutical products in the therapeutic areas of anti-virus, endocrine and metabolic diseases and cardiovascular diseases. HEC is currently manufacturing, marketing and selling a total of 33 pharmaceutical products in the China, and we have established an extensive distribution network within China
Backgrounds：
Yichang HEC digital laboratory construction is implemented in its generic drug CMC R&D Laboratory, which mainly focus on preparation research and quality research, including preparation technology, prescription technology, quality research, impurity research, stability research.
Goals & objectives：
- Enhancing project management capabilities, allows real-time progress monitoring, optimization of project resources allocations.
- Achieving standardized recording of experimental process, experimental results, experimental data and other information, facilitating researchers to quickly retrieve relevant data.
- Realizing the life-cycle management of experimental materials, mastering the information of material storage, receipt, inventory, ledger, etc., and improving scientific research support.
- Automating acquisition of instrument data and calculation to reduce errors caused by manual operation, improving the efficiency of scientific research, and maximize the paperless application during analysis and inspection process.
- System need to be strictly following the requirements of cGMP and FDA 21CFR Part 11, the entry and modification of experimental data are audited, the data can be sourced, and the electronic records and material management system need to be verified in accordance with GAMP5 requirements.
- Establishing a permission management mode that meets the management requirements of Yichang HEC, ensuring information security through hierarchical authorization.
- Realization of information sharing, elimination of isolated data islands.
Our Solutions:
Constructing a comprehensive CMC digital management platform, achieving full workflow management during CMC stage. Incorporating multiple systems including: Project Management (PM), Electronic Notebooks (ELN), Instrument Management (IM), Material Management (MM)，Stability Study Management (SM), and Sample Inspect Process management (SIP).
Results & Benefits:
Project Management:
Project leaders are having a more intuitive understanding of their own project situation, able to make arrangements and decisions accordingly.
The project management department can track the progress of the project more intuitively and easily.
Project documents can be archived online, electronic data storage is more convenient and more secure.
Material Management:
Easily checking the physicochemical properties of the reagents used, toxicological data, safety of use and other information.
Improved inventory searching, chemicals claiming applications can be processed online, reducing communication costs.
Short claiming time, better traceability for chemical usage, with E-signatures.
Improved warehouse efficiency, the materials can be prepared in advance according to the online application, and the error rate is greatly reduced.
Automated inventory information update and summarization, making the inventory more intuitive and accurate.
Electronic Lab Notebooks:
The efficiency of experimental record writing is greatly improved, and the standard of experimental record writing is improved by pre-build template and schemes.
Electronic time records is impossible to be falsified, avoiding the situation of writing records based on memories, greatly improving the accuracy of the original record.
Corresponding backup schemes for data stored in electronic media to ensure data security.
Fast PDF data parsing and extraction, which greatly improves the writing efficiency and data accuracy of related experiments of quality research.
Stability Studies:
The system reminds the stability manager to placing and retrieving samples according to the study scheme, avoiding omission of placing and retrieving.
Online stability scheme management, The stability plan is automatically generated according to the scheme.
Placing and retrieving records are automatically generated, samples can be quickly sent for inspection and analysis, and the analysis results are automatically returned, which is convenient to view at any time.
The stability research scheme can be flexibly adjusted at the duration of the plan, and the inspection spot or analysis items can be quickly added.
Instrument Management:
Achivieving online Instrument management, scientists can check the status of the instrument at any time.
Instrument appointment allows better resource allocation
Mobile App with QR code scanning function, allows users to use instrument much easier. Automated using ledger recording.
Instrument calibration and maintenance plan can be managed online, reminders will be sent accordingly.
