All training records should be considered:
21 CFR Part 11 applies to all digital records within your life science organization. That includes your learning and development initiatives. It is important to understand how the FDA’s rules affect training records, including their storage, access, and more. Of course, navigating this area can be confusing, so we created a guide to help ensure you can comply with legal requirements and avoid an FDA audit. Show
What Training Records Are Affected?Technically, all electronically-stored training records fall under the purview of 21 CFR Part 11. In most cases, they must also comply with Good Manufacturing Practices, Good Clinical Practices, and Good Laboratory Practices. However, the most important training records include the following:
Why Are Training Records Kept?Training records serve several important purposes within life science organizations. Some of the most common reasons for storing and maintaining training records include the following:
The Onus of CFR Part 11 Compliance with Training RecordsWhile 21 CFR Part 11 is complex and can be confusing, its application when it comes to training records can be broken down and made more understandable. The PurposeThe entire purpose of 21 CFR Part 11 is to protect training records (and the information they contain) from theft, loss, or damage. All industries have seen a dramatic rise in data breaches, data theft, and cyberattacks, which can compromise any form of electronically-stored data, including training records. The MethodGiven the purpose, how are training records supposed to be secured? The FDA leaves a lot up to the organization, simply mandating that all records be secured and protected, including when they are created, modified, or archived. Life science organizations must:
The SystemElectronic documents (including training records) must be stored in some sort of electronic system. For instance, employee workstations include Excel sheets, Word docs, and other electronic files. The organization’s training records must be stored within a compliant learning management system (LMS). However, that LMS must meet FDA requirements, as well. While most of the onus falls on the life science company to design and then implement policies and procedures that safeguard electronic records, the systems the organization uses must also be “fit for use”. When it comes to learning management systems, there are several technical aspects of the rule that must be met. These include:
How Does an LMS Meet These Requirements for 21 CFR Part 11 Training Records?While the life science organization is ultimately responsible for actual 21 CFR Part 11 compliance, learning management systems must be up to the task. For instance, with an LMS like eLeaP, it becomes a simple matter to ensure that all training records are always up to date and ready for auditing or sharing with the FDA. With robust reporting capabilities, in-depth tracking and learner management tools, and powerful e-signature and digital security steps, eLeaP delivers not only peace of mind, but a defined road to 21 CFR Part 11 compliance. Will the Right LMS Guarantee 21 CFR Part 11 Compliance?In a nutshell, no. No system can guarantee compliance with 21 CFR Part 11. The reason for this is that there are three controls needed for a compliant system. One of those controls, the technical aspect of everything, is provided by the LMS developer. The other two, procedures and administrative processes, come from the organization. So, if the organization has not created robust policies and procedures, or fails to hold individuals accountable for actions taken with their electronic signatures, it will not be compliant. Ready to experience the difference that a compliance-ready LMS can make? At eLeaP, we understand how critical it is to have a robust learning management system that delivers an ideal user and administrative experience, while simultaneously helping you move toward 21 CFR Part 11 compliance. Contact us today to learn more. What is a training record?Training records are evidence that certain people attended certain classes. Typically, training documentation includes the training topic, the name of the instructor, the date, and the trainee's name.
What information must be included in the employee training record?The employer must maintain training records to show that the training required by paragraphs (a) through (c) of this section has been accomplished. The training records must contain each employee's name, the name of the trainers, and the dates of training.
Which of the following provides a brief overview of a written report?An executive summary is a brief overview of a report that is designed to give the reader a quick preview of the report's contents. Its purpose is to present the key points of a report in one place.
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