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Design consulting services
Based on the URS and other similar process description documents provided by the customer, design the process flow diagram PFD, Including production process, capacity calculation, unit operation, etc; After the PFD is completed, we will design the P&ID diagram, Provide a more detailed description of processes, instruments, and utilities; At the same time, technical specifications for process equipment and common equipment in the process production system will also be proposed. At the same time, throughout the entire process of process design, multiple audits were conducted to ensure that the design meets the customer's URS requirements, and a URS response form was provided
Based on the customer's process requirements, propose an engineering implementation plan and corresponding verification plan from the critical path and node, to ensure the safety of the verification work
By evaluating the key product quality attributes of customers, a quality attribute control plan can be proposed, which can all adopt paperless recording methods to improve the stability and traceability of product quality parameters; Design solutions for customer factories throughout their lifecycle to reduce overall resource consumption.
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Validation Training Services
Jichen Bio-tech provides professional and comprehensive one-stop services for GMP compliance and quality management consulting, covering four service processes: engineering, validation services, quality, and training
Verify the V model
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Provide you with comprehensive and detailed high-quality solutions
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02.
Self-contained upgrade service
1.Software upgrade
This computer and software upgrade is aimed at upgrading and renovating equipment and facilities whose original operating software cannot meet current legal and regulatory requirements. This type of equipment is often manufactured before the introduction of the 2010 version of GMP. PLCs and computers need to be replaced, and software needs to be rewritten. This type of upgrade requires synchronous implementation and verification with the changes and verifications of the demand side before it can be delivered for production use.
2.Hardware upgrade
This type of renovation usually involves adding or expanding the functions of existing equipment and facilities, often by replacing and upgrading the main components of the original equipment to achieve the expected goals, Realize automation and intelligent production by strengthening supporting facilities. This type of upgrade often requires partial renovation of the workshop, and after the renovation, the workshop generally requires GMP acceptance. Similarly, changes and verifications from the demand side need to be implemented simultaneously, and once verified, they can be delivered for production use.
3.Integrated Services
Centralized monitoring, data backup, and tracking of the operation and operation of key production equipment. Usually, after networking multiple devices, a new director's computer is added, The monitoring computer data is synchronously collected and stored with the device. Such upgrades are often implemented synchronously with computerized verification.
The main equipment in the workshop is networked as the overall monitoring system, which synchronously collects, stores, and tracks data throughout the entire production process.
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After-sales maintena
1. Factory acceptance stage
Written customer satisfaction survey form
2. On site construction phase
Starting telephone connection; Pre -, mid -, and post QC questionnaires; Telephone follow-up after withdrawal
3. After project SAT
Telephone follow-up within one month after SAT; Telephone follow-up one month before the end of the warranty period
4. Outside the warranty period
Annual customer satisfaction follow-up
5. Establishment and maintenance of maintenance data
Project information; Technical data; Execution records; Previous after-sales records; Customer equipment operation status
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Comprehensive pre-sales service
1. Layout design of the factory: Based on the actual situation of the factory, our lean production experts will provide you with a comprehensive equipment layout plan, which can improve production efficiency, save space costs, and reduce process inventory
2. Equipment design scheme: Our company's products adopt modular design and variant management technology, which can quickly provide flexible and versatile technical solutions according to customer needs
3. Exploration and technical exchange of freeze-drying curves: Our pharmaceutical experts will provide reference opinions on sample trial production and parameter recommendation. And we can provide an authoritative technical exchange platform to explore suitable solutions with customers together
Professional in sales services
Our company's products comply with international GMP, CGMP, EU GMP, FDA, WHOPQ, TGA and other regulatory standards, And ensure sterile operation throughout the entire lifecycle. Each project will provide real-time project feedback to customers at each stage of initiation, design, manufacturing, testing, and acceptance, Ensure that each device delivered to the customer strictly complies with the customer's technical requirements.
Comprehensive after-sales service
The after-sales service is comprehensive, including on-site installation, commissioning, and acceptance of equipment, as well as training for operators, Equipment maintenance and upkeep, long-term supply of spare parts, collection of data on the use of vulnerable parts and prompts on the number of operations, equipment software and hardware upgrades and renovations.