Total IDMP Solution: Assessment
Dive deeper into company sites, experts, documents and systems to map current regulatory knowledge into IDMP compliance in preparation for the Master Data system architecture.
While existing standards such as XEVMPD (eXtended Eudravigilance Medicinal Product Dictionary, from the European Medicines Association) required codification of existing product knowledge found in the Summary of Product Characteristics, that previous work amounts to only around 6% to 10% of what is needed for IDMP, and even combining existing structured documents and system data will only provide 20% to 40% of the requirements. The remaining 60% to 80% will need to be extracted from other documents found across the enterprise.
Where are your data sources?
Find Your Data: CSC Analysts will work with your information technology team to map the areas of data, from active systems or archived submission documents. CSC works with you to locate the data amongst the varied sources.
A substantial part of product knowledge is currently siloed, not just in separate systems and documents, but also in separate locations, e.g., local affiliate offices have traditionally held control over product licenses and other details in each country. For IDMP to succeed, this information must be centralized.
Assign Responsible Party: Identifying the source is only one side of the puzzle pieces: Each piece needs to be owned by a responsible party, whether that is the Business Owner of a core system such as Submission Management, or the department lead who manages the authors of documents such as manufacturing contracts. This is critical to ensure:
- Issues during collection of data for IDMP have an authority who can resolve them
- Maintenance of data over the course of time prior to IDMP data delivery has a responsible source
Assessment Outcome: This phase builds the map to identify data extraction for the next phase. The outcome of this stage includes the list of all data sources, and the plans to import each class of data into both the interim IDMP data store, and to the final Master Data Management system architecture.