KATHERINE FRANZ¹, MICHAEL HOWE²
1. Executive Director, The Axia Institute, Michigan State University, Midland, USA
2. CEO, Verify Brand, an OPTEL company, Minneapolis, USA

Abstract

As pharmaceutical organizations go through the process of choosing serialization solutions to meet upcoming regulatory deadlines, they must ask an essential question – how can I meet compliance mandates while at the same time improve my overall business operations? Fortunately, when track and trace systems are properly architected, pharmaceutical organizations can gain unprecedented visibility into value chain operations, resulting in end-to-end efficiencies and actionable insights far beyond compliance.

INTRODUCTION

The prevailing wisdom in the pharmaceutical industry is that serialization compliance around the world is no longer an option, it’s a necessity. For the past decade, lot-level traceability and serialization compliance projects have been at the forefront of pharmaceutical manufacturers’ attention. Recently, global government-mandated item-level serialization requirements have begun to affect every party in the pharma value chain, from manufacturers to distributors, re-packagers, pharmacies, and even patients.

As pharma organizations go through the process of choosing item-level serialization solutions to meet regulatory deadlines, they must ask a tough question—do I go with basic compliance software or do I choose a solution that not only checks the compliance box but improves my overall business operations simultaneously?

According to KPMG’s 2017 Serialization & Traceability Trends (1) report, more than 70 percent of pharmaceutical organizations surveyed agreed that serialization data has the potential to transform business processes. Currently, pharmaceutical organizations are spending millions of dollars ...