Biacore™ Insight GxP Extension
Empower your GxP regulated tasks with our specialized software extension.
Biacore™ Insight GxP Extension
Empower your GxP regulated tasks with our specialized software extension.
License type
Overview
Biacore™ Insight GxP Extension allows Biacore™ 1 series and Biacore™ 8 series SPR systems to integrate seamlessly into GxP-regulated workflows. The software extension provides validated software supporting GLP/GCP/GMP and 21 CFR Part 11 compliance. The software has been developed in accordance with an accepted development model to ensure adequate validation. For full validation support of the system, the software extension can be supplemented with our OptiRun™ Qualification Service. Features in the GxP extension include:
- 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 in routine assays.
- Audit trail tracks record modifications and maintains complete version histories for published procedures.
- eSignatures for new procedures and finished evaluations
Floating e-licensing for enhanced flexibility
Biacore™ Insight Software and extensions introduce floating licenses to allow sharing of access rights between users and computers. Electronically secure a machine license for one computer, or a concurrent license for networks, saving license costs. Time-limited licenses let you scale the number of licenses needed for more flexibility.
