The quality management system of Philips Pharmaceuticals is a quality control and quality assurance system designed by Zhuhai Qi Fei Software Co., Ltd. according to the new GMP plan. It connects laboratories, production workshops, warehouses, quality control departments, middle and senior management leaders and relevant departments to form a unified business supervision platform, standardize the quality supervision process and realize quality control. Solve the following core problems of the enterprise:
1, analysis, sample life cycle monitoring
In the sample analysis cycle, the processing time of each link (such as inspection, sampling, sample collection, result entry, review, audit, report release, etc.). ) statistical analysis, so that managers can know the test progress and stranded nodes in time, and urge relevant personnel to carry out relevant operations in time to ensure that the test is completed on time.
2. Establish scientific and continuous stability inspection to ensure product quality.
The system provides two solutions: key sample retention and stability check. It only takes one time to reserve varieties for automatic inspection, and users don't need to go to the sample retention account every day, which can reduce the workload of sample retention personnel. In addition, the system will automatically generate a sample retention account to facilitate the tracking and statistical analysis of product quality. In addition to the sample retention function, the stability check also provides the approval process of stability scheme, interim report and final report, as well as the failure warning function.
3, all-round environmental testing, dialysis quality trend
The environment of production workshop or microbiology room can be tested according to different testing items and grades, and accurate testing data can be obtained according to its standards, and environmental quality reports can be obtained through statistical analysis of data to provide decision-making data for managers.
4, improve the verification management norms, put an end to quality hazards.
From the GMP certification of domestic enterprises, verification is also the weakest link in GMP implementation. Due to the lack of strict verification of production technology, factory facilities and equipment, there are many quality hidden dangers in the production process. The system provides a simple and flexible process approval method, which can track and trace the whole process of verification in time.
5, the introduction of risk assessment mechanism, improve the change, deviation, audit and other quality processes.
According to the latest GMP requirements, the risk assessment management system is introduced into the system, which greatly improves the process of quality change and deviation. The risk assessment process begins when the user deviates from and changes the process. When the risk assessment process ends, the system will automatically write the results back to the deviation and change process to complete the whole quality process.
6. Process file management, real-time recording, tracking and monitoring.
The system provides a complete set of quality document management system for enterprises to choose their own document management, to ensure that everything is well-founded, recorded, traceable and monitorable, to prevent errors, confusion, pollution and cross-pollution, and to ensure quality safety, effectiveness and quality control.
7, show certificates, strict training management.
Pharmaceutical enterprise personnel must undergo GMP training before they can take up their posts. Establish a perfect training system for enterprise production and inspection management, including personnel files, training plans, training assessment and other functions. Employees can only operate after passing the training, and strictly abide by GMP requirements to ensure the quality and safety of drug production.
8. Strict supplier control and quick traceability.
The system strictly controls the qualification investigation, audit, evaluation and pilot test of new or changed suppliers, and analyzes and tracks the information provided by them, including supplier inspection batches, qualified batches, unqualified batches and qualified rates. , and subdivide it into each material provided by suppliers to monitor the registration certificates of different materials.
9, real-time and accurate early warning platform, take precautions.
The system provides an early warning platform, which enterprises can set according to their needs. The following early warning indicators are provided: first, early warning lines are set for key indicators such as intermediate products and finished products of key varieties, so that whether the varieties exceed the early warning line can be judged at the same time of score registration; Second, sample retention and stability inspection will automatically remind relevant personnel and automatically generate inspection application forms; The third is automatic early warning and reminding of unqualified finished products; The fourth is the early warning of supplier qualification expiration; The fifth is the early warning of reagent and material inventory and so on. The system can automatically notify the quality management personnel, so that the person in charge of quality can analyze and deal with the product quality problems in time and avoid losing the best opportunity to deal with them.
10, efficient and safe electronic seal signature, paperless office.
Support report electronic seal and personal signature, improve work efficiency and realize completely paperless office.
1 1, intelligent analysis report to assist leaders in making decisions.
On the basis of data accumulation, implement intelligent graphic report analysis system and improve decision analysis system; Implement early warning analysis, lead the quality cockpit, and conduct in-depth analysis of business data to serve decision-making.
12, automatic instrument data acquisition
Using "device-independent" software and hardware interface technology, automatic instruments with different interface types are connected with LIMS. As long as the instrument has data output function, no matter what method is adopted, it can realize fast and automatic data acquisition.
13, seamless system integration, integration of enterprise resources.
The system has good expansion and integration ability, that is, it supports the integration with ERP, HR, finance, CRM, MES and other systems, thus optimizing enterprise resources and reducing enterprise production and office costs.
14, mobile office, global "handheld" control of information
The system supports mobile phone short message platform and mobile application of intelligent terminal (mobile phone), and leaders can view statistical reports such as product nonconformity, production quality process, product stability and inspection cost summary table on mobile phone.