流式细胞术软件
Photo for reference; configuration may vary by order.
Model No. CYS-0004 · Flow Cytometry Equipment
符合 21 CFR Part 11 的临床流式细胞术软件
Cell therapy release testing, GLP studies and central lab trials need flow data that will stand up to inspection. This package adds unique user IDs, a time-stamped audit trail that cannot be edited, two-component electronic signatures and locked assay templates. IQ/OQ protocols and a traceability matrix ship with it; HL7 or ASTM links are optional.
| Place of origin | China (dispatched from Shanghai) |
|---|---|
| Brand | Liquid International / OEM on request |
| Export packing | Fumigation-free plywood case or reinforced carton |
| Loading port | Shanghai / Ningbo (others on request) |
| Payment terms | T/T, L/C at sight (confirmed on quotation) |
| Trade terms | EXW, FOB, CFR, CIF, DAP |
Typical export terms — final terms are confirmed on the proforma invoice.
Cell therapy release testing, GLP studies and central lab trials need flow data that will stand up to inspection. This package adds unique user IDs, a time-stamped audit trail that cannot be edited, two-component electronic signatures and locked assay templates. IQ/OQ protocols and a traceability matrix ship with it; HL7 or ASTM links are optional.
| Parameter | Value |
|---|---|
| Regulatory frameworks 监管框架 | 21 CFR Part 11, EU GMP Annex 11 |
| Access control 访问控制 | Role-based, unique user IDs |
| Audit trail 审计追踪 | Time-stamped, non-editable |
| Electronic signature 电子签名 | Two-component (ID and password) |
| Template locking 模板锁定 | Approved assay templates |
| Data storage 数据存储 | Secure database with backup |
| Validation documentation 验证文件 | IQ/OQ protocols, traceability matrix |
| LIS/LIMS integration LIS/LIMS 集成 | HL7 or ASTM interface (optional) |
| Operating system 操作系统 | Windows 10/11, Windows Server |
| Report output 报告输出 | Signed PDF reports |
| Model No. | CYS-0004 |
| Place of origin | China (dispatched from Shanghai) |
Chinese national standards (GB/T, JJG) and international standards referenced for this product type. Test reports and certificates are supplied with the quotation on request.
Fumigation-free plywood case or reinforced carton
Every unit is power-tested before packing; enclosed in shock foam and moisture barrier; wooden cases comply with ISPM 15.
Shanghai / Ningbo (others on request)
Full container load (FCL), less-than-container load (LCL) or air freight; complete export documentation provided.
Complete the form below — an export engineer will send technical configurations and a formal proforma invoice within 24 hours.
Single instruments, complete laboratories or government tenders — our export engineers prepare the configuration, proforma invoice and shipping documents.
