- 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 recommendationsRead more
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.Read less
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