HOW TO IMPLEMENT A SUFFICIENT DATA GOVERNANCE POLICY TO ENSURE COMPLIANCE WITH DATA INTEGRITY REGULATIONS IN THE LIFE SCIENCES SECTOR.

What is “Data Governance”?

(Data Governance -MHRA) * – 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.

Data governance should address data ownership and accountability throughout the lifecycle, and consider the design, operation and monitoring of processes/systems to comply with the principles of data integrity including control over intentional and unintentional changes to data.

*MHRA ‘GXP’ Data Integrity Guidance and Definitions, March 2018

The term data governance emerged to describe the concept of managing and influencing the collection and utilization of data in an organization.  Data is now one of the most valuable assets in any organization now that we transition into a more analytically driven industry. Data is now the longest lasting asset in any organization, outliving facilities, devices and people.

Often organizations will either over-apply data governance in their enthusiasm for the new function; or under apply data governance due to their lack of experience.  The best approach is to start off with a broad vision and framework, but limited application, and expand the governance function incrementally, only as needed, and no more.

Why do we need Data Governance?

Data Governance helps protect a company’s more important assets: knowledge and data. This in turn has an impact on decision-making, risk mitigation and brand identity.

Therefore, it is recommended that a Data Governance Office is set-up, also called the Master Data Council, which enforces data governance. Roles should include an overall Sponsor or Committee, IT & Business Representatives and a Program Leader at the very minimum.

Who does what in a Data Governance program?

The Data Governance Office makes a set of rules in the form of policies, standards, requirements, guidelines, or data definitions etc.  These individuals should ask the following questions to achieve data governance.