In any industry where data is a major component for regulatory approval or compliance (e.g., Biotechnology/Pharmaceutical), regulators need to efficiently review and process this data while reducing the financial burden and effort of compliance to industry, in turn reducing the cost and risk to consumers.
To achieve these goals, many regulators have established data standards. However, as regulation and the number of standards increase, so does the time and effort it takes to develop, manage, and distribute these standards in a way that truly results in the benefits intended.
Not only do issues exist for standards development organizations (SDOs), but implementation of these standards are often very burdensome and expensive for industry due to their impact on business processes. As a result, organizations typically perform duplicate work to convert data to standardized formats after the fact for regulatory purposes to avoid such disruption to their business operations. This inefficient approach results in longer cycle times, higher costs, and lower quality data; the opposite of what was intended.
Solution - Semantics Management
Data standards alone are not enough to overcome these issues. Only through Semantic Interoperability (SI) can regulatory agencies and industry achieve benefits from these standards. Semantic Interoperability is the ability of computer systems to exchange data with an understood or common meaning of the data without human intervention or interpretation. By binding systems to robust common domain terminology produced and disseminated by SDOs (i.e., Semantics Management), industry can more efficiently implement end-to-end data lifecycle processes.
Some of the key benefits of semantics management include:
- Regulatory compliance regarding the use of data standards
- Decreased time to market, cost, and resources as a result of improved business processes
- Improved data quality
- Maximum reuse of existing metadata and data assets
- Significantly reduced need for human intervention with data exchange
- Knowing exactly where and how content is being used, and
- Understanding how changes to content affect other people, processes, and systems
SOA Software’s Semantics Manager is built upon an industry-leading repository and governance platform. It enables SDOs to develop, obtain and incorporate reviewer input, manage, and distribute standards more efficiently. It also helps industry to implement standards faster and more effectively while automating and improving business processes. Semantics Manager is like a virtual hub for data within your enterprise. It helps users to define, find, understand, use, and exchange data.
Register to download the SOA Software Semantics Manager Data Sheet and other resources.