Biacore 8K+ and Biacore 8K can be upgraded to work in regulated environments with Biacore Insight GxP Extension. This extension provides validated software supporting GLP/GCP/GMP and 21 CFR Part 11 compliance and includes validation service.

  • Data integrity through access control and enforced version handling.
  • User authorization levels where administrator, developer, and user levels set access rights to software functions.
  • Procedures for operational control enables assay run and evaluation settings to be locked together in routine assays.
  • Audit trail tracks record modifications and maintains complete version histories for published procedures.

For full validation support of the system, the software extension can be supplemented with Cytiva Qualification Service. The software is developed in accordance with an accepted development model to ensure adequate validation.

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Product Product Name Price
29332212 Biacore Insight GxP Extension Permanent, single license On Request Get Quote
29332213 Biacore Insight GxP Extension Permanent, 5 licenses On Request Get Quote
29332214 Biacore Insight GxP Extension Permanent, 10 licenses On Request Get Quote
29332215 Biacore Insight GxP Extension Permanent, 20 licenses On Request Get Quote
29332216 Biacore Insight GxP Extension Expiring (1 yr), single license On Request Get Quote
29332217 Biacore Insight GxP Extension Expiring (1 yr), 5 licenses On Request Get Quote
29332218 Biacore Insight GxP Extension Expiring (1 yr), 10 licenses On Request Get Quote
29332219 Biacore Insight GxP Extension Expiring (1 yr), 20 licenses On Request Get Quote

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