Data Integrity Guide: Spreadsheet Validation
Strengthen Spreadsheet Controls. Reduce Compliance Risk. Spreadsheets remain one of the most widely used tools across pharmaceutical operations, supporting everything from laboratory calculations and stability programs to equipment maintenance, quality systems, and product release decisions. […]
The Next Episode | What 13 Years of DSCSA Teach Us About NDC-12 and Pharmaceutical Interoperability
The Transactions Haven’t Changed. The Network Has. Flying home from the HDA Traceability Seminar last week, I saw some news from Philadelphia that put much of what we had spent the previous few days discussing […]
HDA 2026 Traceability Seminar: From Implementation to Interoperability
What comes next for DSCSA OPERATIONS AND INTEROPERABILITY Thirteen years after DSCSA became law, the industry’s focus is shifting from implementation to sustained operation. At the 2026 HDA Traceability Seminar, discussions increasingly centered on what […]
When Distribution Models Change Faster Than Controls: GLP-1, DTC, and the New Pharmaceutical Risk Landscape
Within this slide deck, you can explore how GLP-1 demand, telehealth, digital pharmacies, and direct-to-consumer distribution are reshaping the pharmaceutical supply chain and creating new patient safety and security challenges. Rx-360’s Ryan Kelly, Interim CEO […]
Strengthening Patient Safety Through Practical Supplier Quality Oversight | Insights from an Rx‑360 Supplier Quality Working Group Informal Survey
Ensuring patient safety depends on the integrity of global pharmaceutical supply chains—yet Supplier Quality professionals continue to face practical, structural challenges in how audits are conducted, documented, and leveraged for assurance. To better understand current practices, Rx‑360 […]
Supplier Assessment Questionnaire (SAQ) Guide
TURN INSIGHT INTO ACTION WITH THE RX‑360 SAQ GUIDE The Rx‑360 Supplier Assessment Questionnaire (SAQ) Guide provides a practical walkthrough of how to effectively use the SAQ within your supplier qualification program. Designed as a […]
Rx-360 DSCSA Readiness Checklist for Distributors
Wholesale distributors play a pivotal role in safeguarding the integrity of the U.S. pharmaceutical supply chain under the Drug Supply Chain Security Act (DSCSA). The Rx‑360 DSCSA Readiness Checklist for Distributors distills core requirements into […]
Rx‑360 DSCSA Readiness Checklist for Manufacturers
Ensuring full compliance with the Drug Supply Chain Security Act (DSCSA) is essential for maintaining product integrity, meeting FDA expectations, and enabling seamless interoperability across the pharmaceutical supply chain. The Rx‑360 DSCSA Readiness Checklist for […]