Victoria Lander is a market development manager at Nugenesis Technologies, 1900 West Park Drive, Westboro, Massachusetts 01581, USA. Tel. +508 870 7517 vlander@nugenesis.com
21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule
May 1st 2004FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.