Changchun Drilling Pharmaceutical Co., Ltd. and Chuangteng Technology
Create a compliant QC laboratory information platform
With the major reforms in the domestic pharmaceutical industry in the past two years, pharmaceutical companies have adopted a single gmp certification, tracking and inspection supervision and management model, and risk-based flight inspection, follow-up inspection, parallel inspection and other innovative inspection modes, and data reliability. Be the focus of inspections for fda and cfda. In the warning letter issued by fda, ​​the pharmaceutical companies that are questioned about the reliability of data are not lacking in well-known pharmaceutical companies at home and abroad.
In the future, pharmaceutical companies will face increasingly stringent data reliability verification at home and abroad when they apply for new drug declarations and cgmp certification. Under the increasingly strict and frequent inspection situation, it is imperative to speed up the improvement of the reliability risk control of qc experimental data!
LES: cGMP compliant QA/QC Lab SOP Execution System
-Informatization solutions for production inspection quality compliance
LES is committed to automating and paperless the production and experimental processes of pharmaceutical companies. It provides QA/QC laboratories in GMP environment with high-efficiency electronic experimental recording systems that comply with regulatory requirements and are implemented based on SOPs, and realize QA/QC analysis experiments for pharmaceutical companies. The automation of room data collection and reporting is in full compliance with the regulatory requirements of QC Laboratory Data Integrity ALCOA+CCEA.
LES "Method under the glass screen" performs SOP and directly collects instrument data
LES function
LES functional value
Data integrity
Regulatory requirements
SOP file management: Quickly edit SOP files by dragging and dropping visual components
The function of logical judgment can automatically judge the subsequent execution steps or conclusions according to the data entry result.
Complete:
Complete, no omission
Method Execution: Perform the analysis method operation steps through the mobile terminal "method under the glass screen"
No need to flip through the paper SOP documents, which greatly guarantees the controllability of the test process
Contemporaneous synchronization: Recording and operation synchronization
Consistent: consistency, no difference
Data acquisition automation: support serial instrument and connection with workstation instrument, and analyze data result file to automatically collect data
The instrument data is automatically obtained to the test related input items, no manual copying is required, and the error rate is reduced.
Original Original: original first-hand data, not changed
Accurate accurate: consistent with actual operation, no subjective fraud or objective input error
Data review: The data review interface “flag flag†can help reviewers quickly review special items.
Accelerate the turnaround process for data audits, strengthen collaboration between departments, and increase business productivity
Attributable traceable: traceable to the producer or modifier of the data by the signature in the record
Generate an electronic lab record: the original report should be printed with the electronic signature and record of the person concerned.
Generate electronic test records in the data entered during the execution of the SOP method to ensure the accuracy of the information and traceability of the results.
Legible is clear: readability, traceability, and permanent
Electronic signature: in line with FDA21CFR Part11,
EU-GMP technical requirements
Electronic signature has regulatory compliance
Attributable traceable: traceable to the producer or modifier of the data by the signature in the record
Audit Trail: Tracking changes to system data
Full compliance with GMP regulations for data modification requirements
Available: Data is visible at audit time and is not hidden
Interact with LIMS data in a unified database
Preserving and transmitting data based on database level to ensure the authenticity and reliability of system data preservation and transmission
Enduring Long-term: Raw data is stored for a long time, not easy to delete, discard
LIMS: Workflow-based laboratory information management system
Pharmaceutical production and process control involves five basic elements: human, machine, material, law, and ring. LIMS can solve the problem of information management of production testing laboratory elements, providing sample management, data management, personnel management, inventory management, and documentation for laboratories. Management, instrument management and other functions. LIMS meets GxP requirements and complies with FDA 21CFR Part 11, GMP and ISO 17025 standards. It also provides complete audit trails to ensure data accuracy.
Beijing Chuangteng Technology Co., Ltd. has a unique advantage in the LES+LIMS comprehensive solution.
LES products have high authority in the GMP field of pharmaceutical companies. It is a fully validated laboratory SOP execution platform. It strictly controls the experiment personnel to implement and implement step control according to SOP, accelerate the review and approval of experimental records, and fully guarantee QC testing. Integrity and reliability.
The LIMS system is stable, simple to configure, flexible, and complete in system functions. The successful online users of Chuang Teng Technology LES+LIMS include Sichuan Kelun Pharmaceutical, Xiehe Kirin, Zhejiang Drug Testing Institute, Sinopharm Group, and WuXi PharmaTech. Among them, Sichuan Kelun Pharmaceutical has so far implemented QC laboratory paperless management through the regulated LIMS+LES solution of the entire group's 15 base QC laboratories. Under the premise of strictly complying with the pharmaceutical management industry regulations and the new version of GMP, the Kelun Group has established an advanced and efficient laboratory information management platform, and has experienced many GMP inspections during the operation of the system, which verifies the high conformity of the system regulations.
Beijing Chuangteng Technology currently has more than 60 people in the consulting, implementation, verification and development teams. It is the most widely implemented GCP/GLP/GMP/17025-based information system in China. All implementation and verification team members are from well-known pharmaceutical companies and laboratories at home and abroad, and all pass relevant computer verification methodological training. The implementation team is familiar with the GxP industry regulations, understands the FDA and other government departments to review the computer system, familiar with and follow the verification method GAMP5, understand the actual business processes of pharmaceutical companies, and lay a solid foundation for the successful implementation and verification of LES+LIMS. The basics.
?
Napkin Paper,Serviette Napkin,Bathroom Tissue Paper,Premier Tissue Paper
DONGGUAN YEE HUP TRADING CO,.LTD , https://www.yeehupacks.com