By Stephen Lisa
When implementing serialization, drug manufacturers and contract packagers need to be mindful of the complete costs. Pharma Serialization should be viewed as an enterprise solution, rather than a series of isolated local plant or packing line decisions. The initial costs include the direct costs of software, hardware, systems integrations, and validation. Often underestimated, however, are the impact that serialization has on an existing IT infrastructure and the integration costs required to ensure the integrity and security of data as it flows through the enterprise.
Below is our view of the Top 5 Total Cost of Ownership (TCO) considerations to help companies quantify, understand, and control the full costs of serialization.
- Configurable Software is The Wisest Choice
The importance of choosing configurable software in your serialization solution should not be underestimated because it results in implementations that are efficient, scalable, and economical. Systech offers configurable serialization software—designed with elements that can be assembled and realigned to quickly accommodate changing demands without requiring extensive code rewrites. In contrast, customized solutions are rigid, making them difficult to implement and modify.
- Your Data Should Reflect The Actual Supply Chain
The central premise of serialization is to ensure that the data recorded accurately reflects what is happening in the supply chain. Serialization doesn’t just end on the packaging line and any solution needs to incorporate offline operations and rework. Systech supports these operations while our patented functionality facilitates the storage and tracking of a product’s characteristics, through all layers of aggregation and down the supply chain. All Systech software releases guarantee communication compatibility and security between these systems.
- Serialization Should Be a Product Lifecycle Decision
Serialization should not be viewed as a ‘once and done’ deployment. The solution you deploy will exist for a long time and, like any significant IT investment, it will require maintenance and changes, as your business and the regulations evolve. Systech owns the development and maintenance life cycle of our products, so that our customers don’t have to retain their own programmers to update code or address bugs, performance, security, or the addition of new functionality. Systech customers can capitalize on the benefits of our large user base for maintenance support, performance enhancements, and new functionality provided as part of the standard product roadmap.
- Eliminate Surprises with Quality Assurance
Formal Quality Assurance (QA) programs are aimed at eliminating surprises that can produce unexpected spikes in costs and delays during deployment and operations. Systech development, QA, and implementation procedures were developed to meet the cGMP needs of our customers. We maintain the industry’s most comprehensive development and QA procedures. Our Professional Services organization has a working knowledge of cGPM’s and follows the GAMP model for project documentation and implementation.
- Plan for Scalability
Solutions that are able to scale across multiple sites, without custom coding, have a cost curve that is generally linear. Repeatable deployments within a single organization should gain financial and productivity benefits from this scalability. Systech solutions are highly scalable as demonstrated by customer base. Systech solutions are operating today within a majority of the top pharmaceutical manufacturers and CMO/CPOs. Systech is the only company that can offer a holistic and productized serialization solution that transcends all architecture levels from the Enterprise right down to the packaging lines. Ownership of the whole “stack” allows our customers to quickly adjust their programs to new product or regulatory requirements while minimizing the need for costly and time-consuming revalidations.
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