21 CFR Part 11 for QA & IT

Introduction

The effect of 21 CFR Part 11 in the FDA regulated workplace relative to GMP, GLP, and GCP has been broader and deeper, than any other act of the last 25 years. The challenge is how to implement the requirements in an economically acceptable manner, while reaping the long-term benefits in the highly competitive and regulated environment. Companies, which are able to develop efficacious and efficient methods to integrate electronic records and electronic signatures will compile significant advantageous relative to compliance, operations, and approval of new products.

Course Description

Design and implementation of 21 CFR Part 11 requires sound and detailed understanding of the regulations. Bringing legacy (existing) systems into compliance can be especially difficult, if proper planning is not done. 21 CFR Part 11 for QA & IT provides suitable preparation for the assessment, risk analysis, and gap analysis of the required systems.

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 for QA & IT Examination, which tests the course objective requirements for competency qualification.

CACTUS Integration

21 CFR Part 11 for QA & IT 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 Systems
• Electronic Records
• Electronic Signatures
• 21 CFR Part 11 in Practice
• Validation and Compliance Assurance

Learning Objectives

At the completion of this course the trainees will understand:

• The objectives and effect of 21 CFR Part 11
• Quality assurance of electronic records and electronic signatures
• Planning for the compliance life cycle
• 21 CFR Part 11 Validation

Audience

This course is intended for every employee in QA and IT, who needs to understand how to evaluate, implement, and maintain a compliant system for electronic records and electronic signatures.