Description
The Department of Veterans Affairs intends to award a contract for FCS Express Clinical Edition flow cytometry analysis software to De Novo Software on a sole source basis. The software must be fully integrated, FDA-listed, and 21 CFR Part 11 compliant, with features such as multi-user access, automated real-time reporting, and comprehensive audit trails. The contract will be for the provision of this software to support VA clinical operations.
Some key features of the required software include:
• Multi-user access
• Automated real-time reporting
• Integrated spreadsheets, gating, and transformation algorithms
• Comprehensive audit trails
• Permission-controlled workflows
• Embedded QC features
• LDAP/AD Single Sign-On
• HIPAA-compliant logging
• Seamless interoperability with VA laboratory systems (VistA/Data Innovations)