Introduction to this course: 

This course provides key EU GMP Annex 11 guidelines for the use of computerized systems in GMP-regulated activities, ensuring the integrity and security of electronic records and electronic signatures. Understand the roles of system and process owners, risk management, validation, and compliance essentials for effective implementation and regulatory compliance. 

Who should attend: 

This course is designed for professionals involved in GMP-regulated activities who interact with computerized systems. The course is suitable for the following personnel: QA/QC, manufacturing, IT, validation, regulatory affairs, and auditors.

Learning Outcomes: 

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

• Identify the key requirements of EU GMP Annex 11, for electronic records and electronic signatures, and recognize the critical elements of data integrity.

• Describe the differences between qualification and validation of computerized systems within the context of Annex 11.

• Explain the importance of risk management throughout the lifecycle of computerized systems, and describe the differences between open and closed systems, comprehending the regulatory implications and benefits of each system type.

• Summarize the roles and responsibilities of key personnel involved in the development, validation, and management of computerized systems.

What will I gain: 

Participants will gain a comprehensive understanding of EU GMP Annex 11 requirements for electronic records and signatures, enhancing compliance and developing skills in managing and validating computerized systems in GMP-regulated environments.

Prerequisites: 

Prerequisites include familiarity with computerized systems used in regulated environments and a basic understanding of GMP regulations. Prior knowledge of FDA 21 CFR Part 11 regulations is beneficial but not mandatory.

Additional information: 

Course duration: 00:26:00

Course code/version (effective date): L-24/v1.0 (29/09/2023)