Book URL: http://www.pqri.org/workshops/gmp-/pdfs./CFS042203.pdf Book Description: The Present predicate enforcement discretion New approach electronic records Draft guidance rule application signatures Narrow scope requirements risk 21st Century risk assessment electronic signatures The Past Validation FDA regulation rule requirements 21 CFR Part 11 21 cfr part 11 gmp.
Book Size: 1.51 MB PDF.