Due to its complexity, IDMP (Identification of Medicinal Products) readiness is one of the greatest concerns among regulatory affairs. Phlexglobal has designed an IDMP Ramp-Up Program to facilitate a smooth transition from xEVMPD to IDMP.
The gradual ramp up program facilitates a smooth migration from xEVMPD to IDMP. Each step contains a specific scope, time line, deliverable and cost structure.
Step 1 starts with a review of the complete data requirements as per the ISO IDMP guidelines. A data checklist with pre-categorized data types will be provided. The checklist will be the base for the xEVMPD versus ISO IDMP data gap analysis. Web meetings are being used to effectively agree on interpretations. Remote support will be provided during the entire program.
Step 2 and Step 3 are building on the results of step 1. Both steps are being individualized depending on the corporate needs of your organization. Step 1 will result in IDMP reports with correct IDMP data. Step 2 will provide a complete electronically created compliant IDMP submission, ready to be submitted.
The entire program is supported and accompanied with the use of Phlexglobal's IDMP software. Results created and date entered can be exported at any point in time.