Leveraging on effective Data Governance

Working with quality data, in accordance with data standards and also fit for purpose, as we see in Life Sciences, requires good Data Governance. Next to compliance, data governance leads to major internal business benefits such as better data analytics and increased business efficiency (by not having to reformat or rework data), therefore shorter time to market.

Data governance is control and oversight over your organisation’s data management and datasets, including roles, responsibilities, and processes for ensuring accountability and ownership. A solid data governance framework enables an organisation to manage its data as a strategic asset.

Typical industry challenges without solid Data Governance

Data Governance has not yet received the attention it deserves in the pharmaceutical industry. This is primarily due to the organic and historical growth of functions and departments. We have noticed that many pharmaceutical companies have either very limited Data Governance or no Data Governance at all. This results in the following:

1. Data entry in different departments is done with inconsistent definitions, leading to different business rules. As a consequence, data needs manual modification between systems and thus duplicate data entry or increasing complexity in data transfer between systems.
   
2. No Data lineage information resulting in limited transparency of dataflows. It is key to have full transparency of dataflows and know who changes data, how data is modified and in which systems. This to ensure data quality and compliance with data standards.
3. Roles and responsibilities for data are not effectively set, ownership of data is not clearly established within the organisation, leading to unclear accountabilities for data sets.
4. Data quality issues are resolved reactive and manually, without investigating the root cause for a data quality issue. Hereby are preventive actions for data quality issues not established.
5. There is no ongoing monitoring of whether data is fit for purpose for your organisation or whether the state of data is improving over time.

Benefits of effective Data Governance

A well implemented and embedded Data Governance framework will result in proper management of the availability, usability, integrity, quality and security of data within your organisation. Data Governance will also deliver the following benefits for your organisation:

1. Improve Regulatory compliance
   The ability to evaluate, adapt and respond effectively to internal as well as external changes (e.g. Data standard and regulatory requirements).
2. Consistent data definitions
   Drive a common and shared understanding of data definitions – leading to consistent usage and less misinterpretations and rework. This paves the way for data integration and efficient exchange of data between systems, also cross-functional.
3. Solve data analytics and reporting issues
   Proper Data Governance eliminates any unclarity about the meaning of data and reporting. This allows for correct analysis of data and this in turn facilitates quick(er) decision making.
4. Reduce costs
   Solid information is extremely valuable to your business. Cost savings can be seen by reducing errors/duplicates and thus saving time in data correction efforts. Furthermore, Data Governance may increase revenue because more timely data may result in faster regulatory applications, which may result in earlier product registration / launch.

There is no one default method to implement effective Data Governance. Therefore establishing and improving data governance must be tailored to specific situation and needs.