Data management is the discipline of putting in place and executing processes and IT in order to effectively manage data as an asset for the company, ensure high quality data, and enable data driven decisions and intelligence in a hybrid environment.
In a world with an increased importance of data, moving from siloed application landscape and documents to unified platforms, the discipline of data management becomes increasingly important. The change in application landscape further sets the need for an efficient and effective way of doing integrations in a hybrid environment of both on-premises and SaaS solutions.
Establishing a data management platform enables your business to get an overview of data assets. The consolidation and discovery of data also produce insights into data quality issues and an elevated requirement to improve the quality of data. NNIT helps you select the best software for managing, analyzing, and improving your data.
A centralized hub for data can accelerate the next compliance project, since an overlap in data requirements is often the case. Instead of providing the data only to the requesting authority, the data becomes available to every authorized employee in your organization. This way of enabling self-service reduces competency bottlenecks and inspires peopleto utilize data in new ways and create value without the need for a dedicated project.
The data platform does not dictate a certain submission format or delivery mechanism, but rather provides the data in a companywide agreed data structure from which transformations into requested structures can be defined. This also reduces the impact of changes in submission formats by regulators.
An increasing number of requirements from regulators, such as EU MDR and ISO IDMP, demand data to be provided for multiple purposes and scopes.
A data management platform can help you in creating new submission records from the same master record. Data will often need to be extracted from electronic documents, and if no existing system of record is suitable for the data, then it can be stored directly on the data management platform.
Consolidation of data across business units creates a full picture of the data flow and can aid in the overview and optimization of business processes from early drug discovery to post-market safety monitoring.
Having a centralized hub for data makes it easier to reuse the data and avoid it being entered more than once in multiple systems.
Start building a data platform one data domain at a time, using data standards and standard tooling.
Reducing the number of data silos will not only lower the implementation costs by consolidating data and functionality but also lower the impact from changes in the architecture by decoupling systems.
Don’t limit the solution to GxP or non-GxP data but allow for both, but with a different set of metadata and governance rules.
Article written: January 2019