In this blog, we outline the key benefits of leveraging an AMS provider for pharma 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: 

• Navigating complex serialization systems: Serialization regulations are country-specific and each has its own nuances that need to be addressed via system controls or business processes. This means maintaining different master data; integrating with partners; having different data storage requirements; and needing to capture different supply chain transactions.  
• Monitoring an evolving regulatory landscape: As new products are launched or expanded to new countries, you’re responsible for maintaining and creating new product data. Additionally, you’ll have to set up new functionality for each new serialization regulation or existing regulation that you expand into.  
• Managing ongoing support and maintenance: With any new regulation or product launch, you’ll need to monitor and resolve file transfer issues, review release documentation, assess impacts, and determine if an action plan is needed – not to mention also supporting the resolution and/or testing of any needed actions for release updates.  

Maintaining these systems in-house can take up significant time and resources. As such, organizations should consider leveraging an application managed services (AMS) provider for pharmaceutical serialization. Outsourcing IT support allows employees to focus on other strategic initiatives, equips organizations with a team that has additional in-depth knowledge of the system, and provides redundancy if there’s any turnover, and more. 

Key Benefits of Leveraging AMS for Pharma Serialization Systems

1. Expertise and experience in serialization systems: AMS providers can bring a wealth of expertise and experience in serialization systems to your organization. This eliminates the need to dedicate in-house resources to system support and training. At Clarkston Technology Solutions, we have AMS consultants who have decades of experience; we also have redundancy in skills, so if someone is out sick or on vacation, there is another highly skilled and qualified person who has been trained as the backup and can continue to provide support without any type of disruption.  
2. Cost savings through outsourcing: For most companies, monitoring an active serialization solution isn’t a full-time role. With an AMS providers, pharma companies can reap the benefits of having the expertise they need for a solution without carrying the overhead of a full-time employee. Additionally, serialization system skills aren’t the most common, meaning it may be harder to hire the right person at the right cost if you were looking to bring on the role internally instead. 
3. Reduced risk of non-compliance with regulatory requirements. There’s no room for error or non-compliance in the pharma industry. An experienced AMS provider, like Clarkston, brings regulatory and compliance expertise from past projects and clients. We have the ability to leverage learning from one client to the next and share those regulatory updates or learnings with all AMS consultants focused on serialization.  

Choosing an AMS Provider for Pharmaceutical Serialization Systems 

Selecting an AMS provider for your pharmaceutical serialization system should be done with careful consideration. Be sure to look for someone with: 

• Experience and expertise in pharmaceutical serialization systems. As noted above, serialization skills are still not very common in the pharma industry. Be sure to partner with an AMS provider that has a breadth of experience in this space, from implementation to operations to support. 
• Ability to provide end-to-end solutions. A good AMS provider has expertise in all aspects of serialization, including business processes, regulatory, systems implementations, training, and more. 
• Flexibility and scalability to meet changing needs. If you acquire another company that supplies to additional countries, you’ll already have in-house serialization expertise with an AMS provider. This also applies to launching into new markets – your AMS provider will know what to look for when serialization laws are passed or introduced.  
• Proven track record of success: When it comes to ensuring compliance, you need to be sure you’re working with an AMS provider who is skilled, knowledgeable, and credible. Our AMS team has worked with a variety of companies at various stages of maturity to support their live serialization system, and we continue to provide our clients with the best service possible time and time again. 

If you’d like to learn more about leveraging an AMS provider for your pharmaceutical serialization system, reach out to us today.  

Contributions from Megan Weldon