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The main objective of this project is to digitalize the process that requires manual intervention and many tracking mechanisms by creating a standardized trace matrix from all the documents based on the technical contents. In this digitalization process the unstructured and unstandardized data are converted in to a structured and standardized format through automation tools. This digitalized data hub will be uploaded in to Client’s PLM software (TcU) for ease of access with respect to various use cases. Thus we are providing a digitalized solution to the organization by creating a universal trace matrix.
The future vision of this digitalization and change management process is to bring a content based workflow and approval that leads to the benefit of the organization in terms of QCD (Quality Cost and Delivery).
Specification Standardization is a process of converting the unstructured data in to a structured and standardized trace matrix with content based technical information from various sources of products. To achieve this, a digitalization process with enhanced automation tool was used. Compilation of data is essential for a medical product to ease traceability of the product for its changes with respect to regulatory and customer requirements. This compilation of data is done with this digitalization process.
Thus, in the whole medical system various data from various sources will be structured, standardized and made relation to each other in to a unique form to get required details about a particular part in terms of its raw materials, design parameters, CTQ factors, physical properties, chemical properties, functional requirements, label and packaging details, BOM and supplier details. Eventually this digitalization process will be the place for creating the customer required data with customized formats.