Data governance is the sum total of arrangements which provide assurance of data integrity. These arrangements ensure that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure an attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available record throughout the data lifecycle. While there may be no legislative requirement to implement a ‘data governance system’, its establishment enables the manufacturer to define, prioritise and communicate their data integrity risk management activities in a coherent manner. Absence of a data governance system may indicate uncoordinated data integrity systems, with potential for gaps in control measures.
The data lifecycle refers to how data is generated, processed, reported, checked, used for decision-making, stored and finally discarded at the end of the retention period. Data relating to a product or process may cross various boundaries within the lifecycle. This may include data transfer between paper-based and computerised systems, or between different organizational boundaries; both internal (e.g. between production, QC and QA) and external (e.g. between service providers or contract givers and acceptors).