Data Governance

Operationalizing Data Quality through Data Governance • 85

business impact. If the organization has no quality culture, the concept of

data quality will be abstract, distracting, and annoying. Simply writing

new information capture procedures and putting them into a handbook

will not be enough to change the culture of the company; it takes training,

collaboration, and a willingness to make fundamental changes. Manuals

will be put on the shelf and ignored without the cultural adoption.

Step 4: Develop and implement necessary industry and enterprise spe-

cic standards. In the pharmaceutical industry, CDISC standards are well

known and accepted both by industry and regulatory bodies. CDISC has

developed clinical trial standards from trial desig ...