- Online Training
- Introduction to 21 CFR Part 11
Introduction to 21 CFR 11
Throughout the early 1990’s, computerized systems were being widely used by FDA-regulated industries, such as pharmaceuticals, cosmetics, and various manufacturing facilities.
As of August 20, 1997, the FDA allowed electronic records and electronic signatures to be used in place of paper records and pen and ink signatures, so that business can be conducted digitally. Organizations who move to electronic systems see improvements in standardization, productivity, and efficiency.
The goal of Part 11 (as it is commonly called) is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures.
Detailed in this course are the various components of Part 11 and how to properly integrate electronic records and signatures into your organization.
- Self-paced, practical online training
- Downloadable student notes