Notice ID: 36C26023Q0725
Description
The Department of Veterans Affairs, NCO20 is looking for an Investigational Drug System Software platform and installation in support of VA Puget Sound health Care system.
Salient Characteristics
This software must have the following features or requirements:
- Must be HIPAA and 21 CFR Part 11 compliant.
- Must have Records Receive, Transfer, Dispense, Return to Supplier, Destroy, and Adjustment transactions for investigational drugs.
- Must be able to generate investigational drug accountability logs exportable to NCI DARF, NCI ORAL DARF, ACTG, De-Identified and other formats
- Must provide granular inventory tracking down to an individual bottle, vial, or kit number.
- Must be able to supports patient-specific drug tracking.
- Must be able to provides physical inventory monitoring.
- Must be able operate as a standalone system (e.g., without electronic health record interface).
- Must provide support for at least 50 study protocols.
- Must allow for unlimited users, patients, and drugs.
- Must be able to allow for on-premises hosting (i.e., hosting on the local network rather than in the cloud).
Statement of Work
Investigational Drug System (IDS); automation software to aid in the management of VAPSHCS’s investigational drug service. Vendor will provide an Investigational Drug System Software platform (and install service), a secure, HIPAA and 21 CFR Part 11 compliant, web-based application that has the following features:
- Monitors Receive, Transfer, Dispense, Return to Supplier, Destroy, and Adjustment transactions
- Manages a comprehensive drug catalog, protocols, patients, suppliers, documents, and pharmacies
- Generates accountability logs exportable to NCI DARF, NCI ORAL DRAF, ACTG, De-Identified and other format, significantly facilitating the audit process
- Granular inventory tracking down to an individual Bottle, Vial, or Kit #
- Patient-specific drug tracking
- Double signature verification
- Barcoded inventory labels
