Clarkston Partner Shares Expertise on Leveraging AMS for the Life Sciences Industry
November 16, 2023 | Clarkston Consulting’s Jeff Graffeo, an expert in information technology strategy and business process optimization, was recently featured as a guest columnist with Outsourced Pharma for his expertise on leveraging ams for the life sciences industry. Read an excerpt from the piece below or the full article here.
Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
Since the mid-2000s, serialization regulations have been expanding around the globe. The initial focus on global serialization requirements really gained attention with California and Florida regulations that later turned into the Drug Supply Chain Security Act (DSCSA), which provided the FDA with more regulatory control in the drug supply chain and added layers of protection to enhance drug supply chain security. Since then, more than 40 countries have put some form of pharmaceutical regulation in place, all with the goal of ensuring the integrity of the pharmaceutical supply chain and ultimately keeping the patient safe. In the years to come, we will continue to see countries releasing new or expanding their serialization requirements.
With the expansion of serialization requirements, many pharma companies have turned to serialization technology systems to help them manage those complex specifications and regulations and ensure compliance. However, maintaining these systems can bring about an array of challenges, such as …