21 CFR Part 11 Basics

Introduction

The FDA regulation 21 CFR Part 11 specifies the rules for the use of electronic records and electronic signatures. They can be substituted for paper records and handwritten signatures, if the requirements are met. The major points of the regulations include:

• Computer systems must be designed to comply with the act,
• Procedures must be defined to establish a compliant environment,
• Training must be implemented to ensure accurate understanding of the responsibilities of each and every employee.

Course Description

Understanding how 21 CFR Part 11 "should" work is not enough to comply with its regulatory requirements. Before any application is performed by an employee, he or she must first prove a suitable level of competency in the use of electronic records and electronic signatures, their personal responsibilities, and consequences arising from their actions. The course 21 CFR Part 11 Basics provides the essential and necessary coverage towards meeting those needs.

A progressive assessment test of learning objective achievement can be made at the conclusion of each chapter. This will indicate whether or not the trainee has reached a level suitable to undertake the 21 CFR Part 11 Basics Examination, which tests the course objective requirements for competency qualification.

CACTUS Integration

21 CFR Part 11 Basics is integrated into the following CACTUS sub-systems:

• TIMS (Training Information Management System) with 21 CFR Part 11 compliant module
• METAN (Competency Metrics and Analysis) with 21 CFR Part 11 compliant module.

Course Content

• Overview of the Rule
• Electronic Records and Electronic Signatures
• 21 CFR Part 11 in Practice

Learning Objectives

At the completion of this course the trainees will understand:

• The objectives and effect of 21 CFR Part 11
• The concept and what constitutes electronic records
• The concept and what constitutes electronic signatures
• The personal responsibility in company compliance with 21 CFR Part 11

Audience

This course is intended for all levels of technical personnel working in QC/QA.