How To Navigate Compliance With FDA s 21 CFR Part 11
By Kyle Neuman, managing director, SAFE Identity
21 CFR Part 11, the regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance whose companies are subject to inspections by the FDA. These companies include Contract Research Organizations (CROs) and pharma companies who operate clinical trials that produce records which fall into scope of the regulation. The FDA has released guidance on the 2,500-word regulation to bring more clarity to the scope and intent of its controls; however, compliance remains a moving target due to the nature of FDA inspections.