Introduction to this course: 

This course covers key concepts and best practices for managing both paper and electronic records in compliance with GxP guidelines. Participants will learn how to accurately document, store, and maintain records to ensure data integrity and regulatory compliance in the life sciences sector. Key topics include good documentation practices, audit trails, and the distinctions between paper-based, hybrid, and electronic systems.

Who should attend: 

This course is designed for professionals involved in the creation, management, or oversight of GxP records, including personnel from: QA/QC, regulatory affairs, clinical research, manufacturing, data integrity, documentation and record-keeping, and electronic records.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify the key concepts and definitions related to paper and electronic records, understanding their role in records management compliance and quality management within GxP guidelines.

• Describe good documentation practices (GDocP) and their importance in maintaining data integrity and regulatory compliance.

• Recognize the various types of records and their specific requirements for proper documentation and storage.

• Recall the steps involved in the record management lifecycle, from data acquisition to storage and retrieval, and the associated data integrity risks that must be mitigated.

What will I gain: 

In this course, participants will learn about good documentation practices (GDocP), the steps of a records management lifecycle, and how to store different types of records.

Prerequisites: 

Prerequisites include an understanding of good laboratory practices, good clinical practices, and good manufacturing practices. Industry experience in the life sciences sector or related fields will enhance comprehension.

Additional information: 

Course duration: 00:24:10 

Course code/version (effective date): L-22/v1.0 (03/08/2023)