rfxcel kicked off its FDA-approved Verification Router Service VRS pilot in June. The pilot is designed to quantify the readiness of the VRS network to meet the Saleable Returns Requirement of the Drug Supply Chain Security Act (DSCSA), which is scheduled to take effect this November. The FDA pilot builds on the VRS efforts of the Healthcare Distribution Alliance (HDA) and will systematically verify, measure, and report on the ability of the VRS network to meet the functional requirements of VRS.
As part of this effort, rfxcel has begun publishing its detailed VRS test cases with stakeholders, including VRS providers, manufacturers, and wholesale distributors. Although rfxcel initiated this effort, it is too important to belong to any one participant, and we are greatly encouraged by others in the pharmaceutical supply chain that have volunteered to participate in the pilot. For example:
- Improved testing: Another VRS provider reviewed rfxcel’s testing approach and provided guidance to improve the approach and metrics.
- Scanned barcodes: One of the Big 3 asked if barcode scanning could be incorporated in the pilot. An rfxcel customer offered to provide barcodes for scan testing and helped develop a testing approach.
- Independent audit: A consulting firm volunteered to provide resources to review and audit the results of rfxcel’s testing to ensure accuracy and neutrality.
- Improved specification: rfxcel identified a gap in the Lookup Directory (LD) synchronization specification and reviewed the findings with another VRS provider for confirmation. As a result of this effort, rfxcel will submit a joint recommendation to HDA to address the gap.
This is an amazing response, and rfxcel wants to thank the many organizations that are partnering with us to address this vital industry need. We can meet global compliance only if we’re all working together to help the pharma industry and our customers be prepared for regulations.
rfxcel will publish its VRS pilot report to the FDA, and we would love to share it with you too. If you would like to follow the progress of the pilot and all its participants, please contact us for updates about our VRS pilot.