The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General), 211 (Current Good Manufactur-ing Practice for Finished Pharmaceuticals), and 600 (Biological Products: General). Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drugs) apply to critical trials.
Part 11 provides criteria which will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures. See also 21 CFR Part 11.
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture