PDA Letter Article

When Data Integrity Takes Front and Center Stage

by Doug Chambers, MilliporeSigma

Data integrity has become an important item for regulatory agencies focusing on critical aspects of pharmaceutical quality management. This fact became clear with the publication of the UK MHRA’s data integrity guidance in March 2015.

But what does an organization need to do to successfully implement a data integrity strategy? How can an organization ensure its processes meet required quality standards? And how do effective training, system design and control, and data management practices ensure success?