1. Principles in quality assurance: Part 2. Don't hide behind the regulations;Jones;Qual Assur J.,2003
2. Food and Drug Administration 1976
3. United States of America J.C. Calandra, M.L. Keplinger, P.L. Wright and J.B. Plank
4. 21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice;U.S. Department of Health and Human Services, Food and Drug Administration;Fed Reg.,1997