Electronic Records Electronic Signatures Training Course

• 4-Hour Training Course
• Webinar or Face to Face (F2F) Learning
• Expert Trainer With Actual ERES Experience in Life Sciences

This 4-Hour interactive course aims to provide the knowledge and skills required by employees to understand the regulatory requirements regarding Electronic Records and Electronic Signatures.

By completing this course, employees will gain the skills required to implement compliant solutions, to satisfy the regulatory requirements of 21 CFR Part 11 and to ensure Data Integrity of Electronic Data.

Learning Outcomes

In this course employees will gain a comprehensive understanding of the regulations and by completing the course, ensure they are equipped with the skills and knowledge needed to achieve and maintain compliance in their organisations.

Understand the Regulatory Framework:

• Students will understand the regulatory framework and purpose of 21 CFR Part 11, including its history, scope, and significance in ensuring the integrity and security of Electronic Records and Electronic Signatures.
• Students will be able to identify and explain the key requirements and components of 21 CFR Part 11, including controls for closed and open systems, audit trails, and system validation.
  

Understand the requirements for ERES Validation:

• Students will learn the principles and practices of system validation to ensure that electronic systems used for managing records and signatures comply with 21 CFR Part 11 requirements.
• Students will understand the essential criteria for electronic records to be adequately maintained, including how to ensure their accuracy, integrity, and availability throughout their lifecycle.
• Students will be able to describe the requirements for Electronic Signatures under 21 CFR Part 11, including how to establish and maintain secure, legally binding signatures.
• Students will learn how to implement and maintain Audit Trails that comply with 21 CFR Part 11, ensuring that all changes to Electronic Records are tracked and traceable.
• Students will understand the security measures required to protect Electronic Records and Signatures from unauthorised access or alterations, including user authentication and access controls.

Understand the requirements for ERES Management:

• Students will learn how to develop strategies for achieving and maintaining compliance with 21 CFR Part 11, including conducting risk assessments and implementing appropriate controls.
• Students will learn how to effectively prepare for Regulatory Inspections and Audits by understanding what Regulatory Inspectors look for regarding 21 CFR Part 11 compliance and how to demonstrate adherence to the regulations.
• Students will learn best practices for documentation to ensure that electronic records meet Part 11 requirements, including proper documentation of ERES system validations and user training.
  

Target Audience

This course will be of great value to anyone currently working in the Life Science Industry, or any other highly regulated and proceduralised industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.