Compliance with multitudes of global track and trace regulatory requirements involves multiple solution deployments, e.g. packaging line retrofit, line applications, EPCIS system, integration with ERP and warehouse systems, integration with trade partners, CMOs and 3PLs.
In addition, all packaging artwork must undergo the necessary changes to include the data matrix (2D) barcodes and human readable serialization information, ensure that all data exchanges are based on GS1 standards, acquire and deploy additional IT and networking infrastructure and validate the end to end solutions. This calls for deep experience in managing track and trace programs. A systematic implementation approach and program management expertise in managing complex implementation in validated environment is required to ensure the coordinated progress by all sub-project teams and suppliers. Meeting the aggressive regulatory deadlines is mandatory to mitigate the risk of non-compliance.
With years of proven experience in managing track and trace initiatives,
SCMiND specializes in helping pharmaceutical companies in complying with the global track and trace regulatory requirements. Our track and trace methodology, tools, templates and accelerators can be customized to your program requirements.
Our Track and Trace Services