Articles
RSSRisk-Based Approach To 21 CFR Part 11
December 13, 2006
•White Paper: Risk-Based Approach To 21 CFR Part 11
The 21 CFR Part 11 regulation is a comprehensive piece of legislation that outlines the controls necessary for the regulated industry to utilize electronic records and electronic signatures.
Without careful interpretation, however, the requirements can lead to over-engineered solutions that adversely impact the productivity of the industry without providing added benefit to patient health. The goal of this paper is to provide the philosophy necessary to apply risk management, and to encourage manufacturing innovation and technological advances. This philosophy is based on the ideas in the new FDA cGMP initiative. ISPE believes that this approach is equally applicable to all FDA regulated industries.
ISPE is currently working on more detailed material based on the philosophy presented here, covering all sections of 21 CFR Part 11 but focusing on key areas. This material includes more detailed definitions, specific processes for defining risk and identifying appropriate controls, and implementation examples.
Click Here To Download:•White Paper: Risk-Based Approach To 21 CFR Part 11
