Organizations in regulated industries like pharmaceuticals, medical device manufacturing, and life sciences endure stringent compliance requirements. For these organizations, implementing a cloud-based, validated learning management system helps to ease the administrative burden associated with validation and compliance training while still meeting the requirements imposed by the Food and Drug Administration (FDA). The FDA mandates that all life sciences organizations ensure the authenticity of electronic records and signatures, including training records. 21 CFR Part 11 requires controls including audits, system validations, and electronic signatures and documentation for software and systems involved in processing electronic data, such as LMSs. 21 CFR Part 11 applies whenever information is to be electronically generated, amended, stored, transferred or accessed.
FDA Validation Requirements
Companies operating in life sciences are required by the FDA to validate any software they utilize. In a nutshell, validation is documenting that a process or system meets its pre-determined specification and quality attributes. In other words, software validation 1) ensures that the software has been installed correctly, 2) ensures that the product will actually meet the user’s needs, and 3) confirms that the product, as installed, fulfills its intended use and functions properly. Accurate validation documentation is a key requirement for implementing cloud-based solutions and should be documented in accordance with the company’s internal standard operating procedures (SOPs). Software validation can easily become a time-consuming and expensive process, particularly during the mandatory Installation Qualification (IQ) and Operation Qualification (OQ) phases of validation.
Why Choose a Cloud-based Validated LMS over a traditional LMS?
Not all LMSs are created equal. LMSs created for general professional development may not have the functionality to meet all of your regulatory learning requirements. Validated LMSs are designed with regulated companies in mind. With a cloud-based, validated LMS your vendor can provide much of the documented evidence required for the validation process, and to successfully pass a software audit. Overall, a cloud-based, validated LMS can streamline your efforts and reduce costs associated with your validation process. However, expediting your validation process is just one factor to consider, there is some critical functionality that a cloud-based, validated LMS needs to support.
Critical Functionality in a Cloud-based, Validated LMS
- Appropriate Security and Accessibility
A validated LMS must only be accessible by authorized users; therefore two-factor authentication such as unique usernames and passwords are a must to limit access to the system. Additionally, the validated LMS should be able to support a variety of role-specific user access to ensure database integrity.
- Support of Electronic Signatures
A cloud-based, validated LMS must support electronic signatures. The FDA requires that life science companies execute and document employee training. These requirements ensure that employees understand how to perform their duties within their company and industry guidelines. When employee training is provided online, an electronic signature is required as documented proof that the training has taken place. Upon completion of a learning activity, an employee should be prompted to enter their username, username/password, or username/PIN to authenticate their electronic signature.
- Built-in Audit Trails and Versioning
21 CFR Part 11 requires electronic records to have secure, computer-generated, time-stamped audit trails to record the date and time of user actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information; therefore, version control is required. The validated LMS must ensure that audit trails are readily available upon request, in real-time and in both human-readable and electronic format suitable for inspection, review, and copying. Furthermore, audit trails need to be automatically generated when records are changed while remaining secure and un-editable.
- Validation Assistance
As was mentioned before, a cloud-based, validated LMS vendor should be able to provide a validation package that saves you time and money during your software validation process. Complying with Installation Qualification and Operational Qualification reports is far easier to do when it’s provided by the validated LMS vendor that developed the system.
If you’d like to learn how ePath Learning’s LMS technology meets the unique needs of regulated environments, reach out to us today.
Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.
About the Author: Susan Distasio is an eLearning Industry Crusader focused on advocating for advancement and change in the eLearning and professional development industry. As an avid seeker of knowledge and continuous improvement, Susan is happy to share her research, observations, and thoughts regarding “all things related to learning and development.” When she’s not out on the learning crusade, Susan can be found with the wind in her hair riding her Harley or simply enjoying life with her husband, Steve, and her Siamese cat, Elvis, and with family and friends.