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.
Read moreProduct | Product Name | Price | ||
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29332217 | Biacore Insight GxP Extension | Expiring (1 yr), 5 licenses | 9 283.00 USD |
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29332219 | Biacore Insight GxP Extension | Expiring (1 yr), 20 licenses | 25 600.00 USD |
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In Stock Stock on request Limited stock |
29332216 | Biacore Insight GxP Extension | Expiring (1 yr), single license | 2 038.00 USD |
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In Stock Stock on request Limited stock |
29332218 | Biacore Insight GxP Extension | Expiring (1 yr), 10 licenses | 15 600.00 USD |
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In Stock Stock on request Limited stock |
29332215 | Biacore Insight GxP Extension | Permanent, 20 licenses | 102 700.00 USD |
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In Stock Stock on request Limited stock |
29332212 | Biacore Insight GxP Extension | Permanent, single license | 8 169.00 USD |
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In Stock Stock on request Limited stock |
29332213 | Biacore Insight GxP Extension | Permanent, 5 licenses | 37 100.00 USD |
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In Stock Stock on request Limited stock |
29332214 | Biacore Insight GxP Extension | Permanent, 10 licenses | 62 200.00 USD |
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In Stock Stock on request Limited stock |
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