Introduction to 21 CFR 11

Throughout the early 1990’s, computerized systems were 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 that 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.

This course explains the various components of Part 11 and how to properly integrate electronic records and signatures into your organization.

You will:

• Obtain a deep understanding of the regulation and its requirements.
• Learn how the regulations apply at your facility and how to become and remain compliant.
• Facilitate the proper use and maintenance of electronic records and signatures at your facility.
• Take a deep dive into specific requirements including those about validation of computerized systems, requirements for computer-generated, time-stamped audit trails, requirements for legacy systems, and more.