First among the FDA’s newly redefined objectives is to strengthen regulatory science.
“Science underlies everything we do at this agency and to serve the
public health we must have the capacity to effectively oversee the
translation of breakthrough discoveries in science into innovative,
safe, and effective products and life-saving therapies for the people
who need them most,” says FDA Commissioner Margaret Hamburg.
Sophisticated informatics-based handling of clinical and engineering
data will play a major role in the advancement of regulatory science.
With computer-aided inspection (CAI) you can satisfy regulators by
recording and documenting every surface data point and every extracted
dimension for future reference — while cutting iterations, months, and
millions of dollars from the process development schedule.