Level 5 database compliance may have seemed out of reach for small pharma companies in the early days of the Drug Supply Chain Security Act (DSCSA). However, it is now evident that Level 5 is required to fully harness the capabilities of serialization and extend its business value.
Furthermore, the costs of Level 5 serialization are no longer prohibitive. Competitively priced solutions are now available from many pharma serialization providers.
Level 5 Cloud Defined
With a Level 4 solution, a brand owner’s MES/ERP manages the internal operations of manufacturing operations. Level 5 is a cloud-based solution that enables the integration of serialization and business data from multiple locations in the supply chain for pharmaceutical traceability and compliance with DSCSA. Thus, Level 5 extends enterprise serialization to the global network. With a Level 5 pharmaceutical serialization solution, pharma companies can capture and analyze downstream information about supply chain trends and customer usage, thereby increasing visibility to and control of product logistics.
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Downstream Connectivity to Trading Partners
A well-designed and operated Level 5 system enables downstream connectivity to trading partners, including end-users. Products can be tracked through the supply chain and into customers’ hands with much better accuracy and timeliness. Because products are serialized at the primary package, case, and pallet, it is much easier for each member of the supply chain to track the shipment time and place at each step in the supply chain.
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More Efficient Returns Processing
Without serialization and effective Level 5 management, pharma companies find returns processing to be timely and inaccurate. With serialization applied, returns processing can be much more simplified and accurate. In addition, the serialization documentation accompanying a returned shipment is precise and has more detailed and timely information. And with the FDA-required implementation of the Verification Router Service (VRS), pharmaceutical brands can validate the status of a returned product to ascertain its resaleability and ensure regulatory compliance.
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Optimized Demand Management
A well-developed Level 5 serialization system significantly enables just-in-time management, providing shipment documentation with much more reliable, timely, and valuable information. Also, management can notice disappointing sales in wholesale channels and possibly retail channels more quickly and take action to balance supply chains.
Demand management can be optimized by a Level 5 that is well integrated with supply chain partners. As each product is shipped through the supply chain, a timely history of movement can be maintained. Shortages in some markets can be quickly detected, and those channels can be supplied timelier. Also, when brand owners announce recalls, serialization can facilitate this event in terms of timeliness, size of the recall, and geographical focus.
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Faster and More Accurate Recall
The timeliness and accuracy of a recall are significantly improved with serialized and monitored information by an effective Level 5 system, particularly given that shipments are now aggregated at the primary, secondary, and tertiary levels. This results in much greater control and timeliness of recalls and can decrease the financial ramifications of a recall.
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Marketing Support
Pharma companies’ sales and marketing organizations can leverage data of serialized products to better assess customer loyalty, compliance of contracted customers, and new or lost business situations. For example, when a product is scanned, its location and potentially the consumer’s whereabouts are identified and stored in the cloud. With this information, brand managers can build and enforce loyalty programs and ensure products are in the required locations to maximize sales potential while minimizing the risk of counterfeiting.
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Level Playing Field for Smaller/Low Volume Brand Owners
In an increasing number of instances, the cloud empowers small pharmaceutical companies with shoestring budgets to affordably leverage the same or comparable robust tools used by wealthy multinational corporations. In addition, a scalable cloud platform allows low-volume serialization customers access to the same high-end solutions as the more prominent players.
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Rapid Deployment and Shortened Validation Timelines
With the increased adoption of Level 5 cloud implementations in the pharmaceutical industries, validation resources and cloud providers have collaboratively developed standardized protocols for validation. As a result, Level 5 cloud implementations over validated and standardized infrastructure typically have a much shorter implementation and validation timeline compared to in-house implementations with location-specific physical hardware and security implementations.
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Control Over Your Own Data
Level 5 cloud allows pharma companies to share information across authorized external parties. More importantly, cloud providers have contractual agreements and security controls built into their systems to guarantee that only your company’s authorized users can access the company’s data. Any reputable cloud system’s design will be specifically geared toward security assurance and authorized access, with the latest security measures such as encryption, multi-factor authentication, etc.
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Scalability and Flexibility
Based on the brand owner’s requirements, Level 5 cloud infrastructure can be scaled up and down to keep pace with the continuously evolving compliance landscape. Virtual cloud environments inherently provide scalability and flexibility to support such changing requirements.
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Reduced Capex and Ongoing Operational Costs
Implementing a Level 5 cloud solution allows brand owners to reduce the upfront investment costs, as cloud providers work on a subscription model with a fraction of the setup cost of a dedicated on-premises infrastructure. As more businesses are now adopting the same approach, it will drive down the overall cost across the shared service infrastructure.
Level 5 can dramatically improve small pharma’s access to supply chain information and enable organizations to develop innovative marketing strategies, boost their supply chain responsiveness, speed up the recalls and return processes and track and trace the company’s products.
