JMP Alleviates Risk to Patient Safety while Maintaining Regulatory Compliance
JMP’s client is a well known manufacturer of implantable Class III medical devices that are custom manufactured to each patient’s unique specifications. These medical devices are packaged and shipped with a variety of supplemental documents, including physician use instructions, patient identification information, regulatory documentation, and quality related specifications. It is critical to verify a match between the product, package, and multiple documentation packets throughout the packaging process.
This packaging process was previously a manual process and introduced risks related to patient safety, regulatory compliance and brand equity. The customer decided to implement an automated packaging solution for cartoning and document insertion. This new packaging technology required an information technology solution for verifying the match between all steps and components of the packaging process to ensure accuracy.
JMP worked closely with the end user and the packaging machinery manufacturer to design and implement a Packaging Execution Software (PES) solution to manage the packaging process. This solution makes use of the latest Microsoft technology infrastructure, including database, integration, visualization and reporting tools, along with an interface to multiple controllers and scanners on the machine. The system is able to verify the proper product, package and documentation are combined in real time as the product is packaged. This information is then stored for compliance purposes and communicated to other supply chain systems in the information architecture.
JMP’s Unique Value
JMP’s information solutions team delivered a solution that was tailored specifically to the unique needs of the end user, while accommodating and leveraging a complex packaging machine to deliver a turnkey solution for packaging operations. Delivering this solution required a deep knowledge of information solutions as well as advanced skill integrating information solutions with automation infrastructure.
JMP was able to deliver this solution within the strict governance standards for project management, regulatory compliance, documentation and testing that is necessary in this highly regulated industry.
The Client Payoff
JMP and our packaging machinery partner delivered a turnkey solution that enables the client to achieve packaging efficiency improvements while simultaneously managing risk of regulatory compliance, patient safety, and brand equity. Beyond delivering an effective technical solution, JMP’s team was recognized by the client for radical commitment to success throughout the design, development, delivery and support phases of the project.