IOP Qualification Packet

For ThawSTAR® System, Model CFT2, Item No. AST-614

Comprehensive qualification documentation and testing accessories. Step-by-Step IOPQ protocol and summary report templates. Based on GxP industry standards and the GAMP® 5 methodology.

Designed to build on current industry best practices, the IOPQ Packet for ThawSTAR® CFT2 System can help improve compliance under GxP regulations with the aim of reducing costs and increasing efficiency.

The IOPQ Packet includes more than 100 pages of documentation and testing tool accessories to facilitate functional (“Black Box”) testing of the instrument. Integration of ThawSTAR® CFT2 Transporter during the qualification process is optional, and depends on your “intended use”. Protocol templates are customizable to meet organizational needs. Appendices, data sheets, and other support documents are all included in one complete binder.

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Features & Specifications

IOP Qualification Packet for ThawSTAR® CFT2

Part Number: AST-614
Contents Include:
  • Protocol Body section to capture the purpose, scope and strategy for qualifying the instrument
  • Sub-sections to record references, your organization’s SOPs, protocol execution requirements and overall qualification procedures
  • Qualification personnel, equipment, and material documentation forms
  • IOPQ Data Sheets
  • Qualification Packet Overview, Execution Deviation Form Template, and Qualification Summary Report Template

Product Catalog
This product is for laboratory research use only. Any intended use for diagnostic purposes, direct transfusion, or in the production of therapeutic product(s) or vaccines(s) may require advance regulatory clearance which is the sole responsibility of the user, as this is not a medical device that has undergone medical device registration, clearance, or approval by the U.S. Food and Drug Administration (FDA), European Union, Health Canada, or the Australian Therapeutic Goods Administration.