By Jeff Graffeo, Clarkston Consulting
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/Biotech Serialization Systems
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.
Cost savings through outsourcing: For most companies, monitoring an active serialization solution isn’t a full-time role. With an AMS provider, you can reap the benefits of having the expertise you 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.
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 brings regulatory and compliance expertise from past projects and clients.
Choosing an AMS Provider for Pharma/Biotech 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.
- Incident and Problem Management: A good AMS provider should have well-defined incident and problem management processes in place. They should have a ticketing system to track and manage issues, along with established escalation paths to ensure timely resolution of critical problems. Regular communication and updates on the status of incidents are also essential.
- Performance Optimization: The AMS provider should continuously assess and optimize the performance of your applications. They should conduct regular performance tuning, application health checks, and capacity planning to ensure optimal performance and scalability. They should also provide recommendations for improvements and enhancements based on industry best practices.
- Security and Compliance Measures: Data security and strong data governance is of utmost importance in today’s digital landscape. A reputable AMS provider should have robust security measures in place to protect your applications and data from threats. They should follow industry-standard security practices, conduct regular security audits, and comply with relevant regulations and compliance frameworks.
- Change Management Processes: As applications evolve, updates and changes are inevitable. A good AMS provider should have well-defined change management processes to handle application upgrades, patches, and configuration changes. They should perform thorough testing and ensure minimal disruption to your business during these changes.
- Continuous Improvement: The best AMS providers focus on continuous improvement. They actively seek feedback from clients, conduct regular service reviews, and implement lessons learned from past incidents. They should have a culture of innovation, staying up-to-date with emerging technologies and trends to provide proactive recommendations for enhancing your applications.
- Cost Optimization: An efficient AMS provider should help optimize costs associated with application management, which can be difficult as the technology continues to evolve in complexity. They should offer flexible pricing models and help identify opportunities to streamline operations, reduce infrastructure costs, and optimize resource utilization to get the most value out of the services provided.
- Clear Service Level Agreements (SLAs): A good AMS provider should establish clear SLAs with defined response times, resolution times, and uptime guarantees. SLAs ensure transparency and provide a benchmark for measuring the provider’s performance.
- Strong Communication and Collaboration: Effective communication and collaboration are vital for a successful AMS engagement. The provider should maintain open lines of communication, provide regular reports and status updates, and foster a collaborative relationship with your organization’s stakeholders to ensure a successful partnership in the long term.
Working with an AMS Provider
Remember that when selecting an AMS provider, the specific requirements for AMS may vary depending on your organization’s needs and the applications being managed. It’s important to thoroughly evaluate potential providers and ensure they align with your business objectives and expectations.
This article was previously published on Clarkston Consulting’s website under the headlines “Leveraging an Application Managed Services (AMS) Provider for Pharmaceutical Serialization Systems” and “Considerations for Selecting an Application Managed Services (AMS) Provider”. Republished with permission.
About The Author:
Jeff Graffeo is a partner with Clarkston Consulting, advising clients on information technology strategy and business process optimization. With more than 27 years of experience, he pairs his extensive industry expertise with his in-depth technical skills, and counsels life sciences, consumer products, and retail executives through transformational changes. He has led companies through the planning and implementation of initiatives, including mergers and acquisitions, new product development, and compliance initiatives, and also has extensive experience managing full system life cycle implementations with expertise in program management and process alignment.