Biacore™ T200 GxP Package
Biacore™ T200 GxP Package
Biacore T200 GxP Package
28977954
Stock on request
Price includes standard shipping and handling
Overview
- Software provides security features and the technical controls for 21 CFR Part 11 compliance
- Comprehensive compliance support saves time during validation
- Package includes GxP software, handbooks and validation support documentation
For systems used in regulated applications, Biacore™ T200 GxP Package facilitates compliance with worldwide regulatory expectations by ensuring GxP support and 21 CFR Part 11 compliance. The extensive validation guidance documentation includes a system assessment report and recommendations
21 CFR Part 11 compliant software
- Data integrity – access control and enforced version handling
- User authorization levels – administrator, developer and user levels set access rights to software functions
- Published 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
- Data can be exported both manually and automatically in Microsoft Excel (XLS) format as well as Extended Markup Language (XML) format
Validation support documents
In addition to the Biacore™ T200 GxP Software, Biacore™ T200 GxP Package includes Biacore™ T200 GxP Handbook and GxP Validation Support documentation to save time during validation procedures.
Product specifications
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Biacore T200 GxP Package
28977954
Stock on request
Product availability is not guaranteed and subject to change.
