Total IDMP Solution
Comply with Mandates While Building the Controlled Product Life Cycle
Leverage CSC’s unique combination of software, consulting, business process services and application modernization to solve the upcoming IDMP requirements and build a controlled product lifecycle master data environment.
The Identification of Medicinal Products (IDMP) requires structuring information previously only found in narrative documentation, and integrating knowledge from manufacturing, logistics, quality, safety and clinical, as well as regulatory. This challenge requires concerted effort and significant change to databases and processes to manage data around pharmaceutical products.
CSC offers deep domain expertise along with broad understanding of both the technology and the processes required for IDMP, as a component of our Digital RIM solution. Our subject matter experts help discover the scale and scope of the IDMP data requirements dependent on each client’s current data and document management systems. Business Process Outsourcing Services provide the resources needed to remediate current data into a form usable for IDMP. Our Software Solutions assist in the management of the document and data management systems needed for IDMP, and Master Data Management expertise for modernizing existing applications for an enterprise-wide system architecture design of all related data.
Crawl, Walk, Run
CSC’s IDMP offerings include four phases, depending on the maturity and analysis of each client’s IDMP readiness:
1. We recommend a three-day IDMP Workshop for all clients to determine scope and readiness, and validate existing assumptions. This helps set scope and assists in building the teams and the business case needed to move forward with IDMP implementation.
2. IDMP Assessment is an in-depth analysis of the client’s documents and data systems, to map existing data, knowledge, and who the human authorities are behind each piece of the IDMP data.
3. Although a Master Data environment is the ideal final state, in order to comply with the EU Mandate for IDMP of the end of 2017, it may be necessary to Compile and Deliver data in IDMP format. This requires collection of data from existing systems, structured data, and unstructured documents in whatever form they are found. This is done using a combination of automated Natural Language Processing and Business Process Outsourcing Services.
4. The Assessment and Compliance phases help refine the system architecture for the Master Data Approach which may be constructed simultaneously. This will future-proof the Product Lifecycle Management system for control of the enterprise knowledge and downstream re-use.
Related content: Drug Product Registration Processes white paper