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ThawSTAR® IOP Qualification Packet

For ThawSTAR System, Model CFT2

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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Product Catalog

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

For research or further manufacturing use.

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