Focus on data and reap the reward!
To apply a commensurate level of control it helps to not only look at systems and processes, but put the focus on the data. One way to achieve this is to establish a good level of data governance. According to MHRA, data governance is the “(…) arrangements to ensure that data, irrespective of the format in which they are generated, are recorded, processed, retained and used to ensure the record throughout the data lifecycle.” In addition to the long-known process and system owners, new roles for data owners and data stewards have been introduced. Those new roles take care of tactical coordination and implementation for data integrity and implementing data usage management and security policies.
The reward for successful data governance is just the opposite of data integrity issues: improvements in quality, a reduced number of defects, fewer recalls, higher confidence, and overall better decision making.
The data owner, supported by the data steward, is also responsible for managing the data’s life cycle. This is an important aspect of data integrity by design. Actually, data should always have a designated owner at any point in its life cycle. As a baseline, robust risk-based business processes should be defined and implemented and data flows understood. Furthermore, a specific data life cycle should be defined, based on the supported process. This needs to take into account that data may be transferred across multiple systems, and analyze the risks associated with such transfers. Therefore a holistic approach including effective handover of data ownership responsibilities between roles is compulsory.
Although this may sound ambitious: one could argue that finally data integrity is nothing but ‘compliance reloaded’. It is rather the sum of all facets, the level of detail, and the stringency of a data integrity by design approach that is new. Most of its ingredients are usual suspects. However, the importance of data, its quality, and its integrity, cannot be overstated.
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