Introduction to this course: 

This course covers best practices for implementing Good Documentation Practices for electronic documents. Explore data integrity requirements, risk assessment, electronic signatures, accessibility, audit trails, and document management in electronic systems for the life sciences industry. Enhance your knowledge of secure and efficient data handling while transitioning from manual to electronic processes.

Who should attend: 

This course is ideal for quality assurance personnel, compliance officers, document control specialists, and anyone responsible for creating, managing, or reviewing manual GxP documents.

Learning Outcomes: 

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

• Apply Good Documentation Practices (GDocP) for electronic systems to ensure data integrity and regulatory compliance.

• Make use of risk assessments for electronic data, identifying potential data integrity risks and implementing strategies to mitigate these risks effectively.

• Design, develop, and manage robust data governance systems, ensuring proper control, security, and lifecycle management of electronic GxP documents.

What will I gain: 

Participants will gain essential knowledge and skills for implementing Good Documentation Practices (GDocP) in electronic systems. They will also learn to perform comprehensive risk assessments and design, develop, and manage robust data governance systems.

Prerequisites: 

Prerequisites include a basic understanding of documentation practices, data integrity, and experience with computerized systems and electronic data management. Familiarity with regulatory requirements like 21 CFR Part 11 and EU GMP Annex 11 is recommended.

Additional information: 

Course duration: 00:29:12

Course code/version (effective date): L-33/v1.0 (26/04/2023)