Module 12 Presentations

Data Governance/Quality Systems

• Per the MHRA, a Data Governance system is the “ sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained, and used are complete, consistent, and accurate record throughout the data lifecycle” • Data integrity in Pharma is a key concept in our business. Per the FDA, Data Integrity “ refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). • The European Medicines Agency (EMA) added another four items to round out the ALCOA concept – Complete, Consistent, Enduring and Available. This is referred to as ALCOA+

The Organisation for Professionals in Regulatory Affairs