Source: https://www.gyrus.com/The-Role-of-the-Learning-Management-System-in-21-CFR-Part-11-Compliance
Timestamp: 2020-08-13 08:44:24
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FDA 21 CFR Part 11 LMS Validation is very important for industries in which meeting compliance and operational requirements are mandatory. However, not all business managers in such industries fully understand the importance of adopting the use of Learning Management Systems that comply with 21 CFR Part 11 regulations. Issued in 1997, Title 21 CFR Part 11 allowed digital records and signatures to be equivalent to their handwritten counterparts while creating official methods that organizations must use to maintain and electronically submit them to the FDA. If all electronic records met these requirements then the signatures are officially accepted.
If you are a business operating in the pharmaceutical, food, or life sciences industries and wondering what a compliant LMS is, here is everything you must know about LMS with 21 CFR Part 11.
Why Organizations Prefer Part 11 Compliant LMS?
Known to align learning and compliance training to business processes, regulation-compliant learning management systems are preferred by organizations for the following major reasons:
•	Training regarding new SOPs: 21 CFR Part 11 requires personnel to work in accordance with Standard Operating Procedures or written instructions. Therefore, whenever a pre-existing SOP is updated, or a new SOP is introduced, training becomes very important. This is where LMS comes into play. The LMS helps in scheduling as well as tracking the training progress of individuals on SOPs.
•	Electronic training records: Instead of using paper-based records, organizations can keep electronic records of training by using LMS, which is easy, efficient, and time-saving. An LMS can be designed to automatically record who has been assigned to a training class and create reports regarding the progress of different learners on different learning modules on a personalized basis.
•	Creating Training Plans: An LMS can be used to put together different training modules along a pre-specified learning path. Such a structured training plan can be accessed easily by personnel who can follow the defined order of training courses.
What are the key features of LMS for 21 CRF Part 11?
1.	Electronic Signature: Three parameters of e-signature (user ID, password, and update meaning) appear before any important operation takes place in the LMS. The requested operation will not be carried out until the ID and password for the current user are correct. This feature guarantees that there will be no unauthorized access.
2.	Versioning of Courses: An LMS also allows you to have complete control over the different versions of any particular course. Hence, if during an audit, you are required to present the course version which was last completed by the individuals, you can easily use the online transcripts to present the required evidence.
3.	Auditing: Any changes made to the sensitive data or training materials are recorded in the database. These changes can later be audited for the type of change that has occurred, who initiated the change, and when. There can be different types of changes, which may include creating, updating, or deleting sensitive data. The five major areas on which auditing focuses on are - Sessions, Courses and Modules; Exams; Transcripts, Enrollments, and Records; Questions; Courseware.
4.	Reporting: LMS also has a report generation feature that allows users to access the audited information in different formats, like PDF, HTML, Excel, and CSV. A person who has access to compliance reports can view different audit reports such as the Audit Trail Report and Audit Trail User Action Report.
What the Advantages of 21 CFR Part 11 Compliant LMS?
A 21 CFR Part 11 Compliant LMS provides a host of benefits for the company which adopts its use. Such an LMS significantly improves the ease of performing tasks such as:
•	Managing courses, instructors, sessions, and learners.
•	Streamlining assignments of all regulatory and job-specific training.
•	Tracking individual certifications.
•	Maintaining a repository of knowledge assets.
•	Delivering audit reports.
•	Pre-assigning training content.
•	Complying with stringent federal and international regulations with secure audit-trail verification and employee training records.
What Your LMS should provide when it comes to ensuring 21 CFR Part 11 FDA Compliance?
Let’s look at some key features your LMS must provide to ensure you are 21 CFR Part 11 compliant:
1.	Data Access and User Authentication Process: An LMS should provide robust user authentication by requiring strong username and passwords, automatic password expiry, and verified password recovery process. User accounts should not be shared, and one user-id should apply to only one person. For Single Sign-On (SSO) process API authentication should be enabled. The LMS must provide a robust data access structure to control a user’s access and functions based on various parameters.
2.	Audit Trail Access: The LMS needs to enable the authorized user to access different kinds of data points for each field that need to be audited. Also, to ensure compliance with 21 CFR Part 11, a company after deploying an LMS should check whether there are workarounds if certain data points are not present.
3.	Report Generation for Inspection: The LMS should have the ability to generate accurate and complete copies of automated reports both in printable and electronic format for review and inspection purposes.
Non-compliance during regulatory inspections can risk damaging your company’s integrity and reputation. Only a handful of learning management system (LMS) providers offer organizations the ability to meet the FDA’s Title 21 CFR Part 11 requirements. From July 2015 “15.1” release of GyrusAim, Gyrus Systems became the part of this select group of LMS providers.
Included in GyrusAim r15.1 are integrated features that permit your company to ensure compliance with Title 21 CFR Part 11. Enabling these features to assure compliance by adding a layer of security tracking and auditing of any change to GyrusAim data while ensuring audit-trails are properly recorded for every user. All-access and functions within the GyrusAim LMS are controlled by user identifications and passwords. The software also includes additional built-in features are included such as on-screen warnings to managers, manager authentication of warnings, instant de-authorization of an individual, or all user logins by managers when a violation occurs.
Effectiveness of LMS for 21 CFR Part 11
The very fact that regulation-compliant learning management systems deliver trustworthy training (i.e., matching the quality and safety standards of the regulatory bodies) is motivating food and pharmaceutical companies to look for learning systems that comply with HIPAA and 21 CFR Part 11 regulations. Besides data access and user authentication, and report generation, there are certainly other factors that make LMS for 21 CFR Part 11 Offer Effective Training, such as:
•	Control and Tracking of Different Versions of Courses
During an audit, many organizations have access to only their current courses for review. However, it may be the case that trainees/employees have completed a previous version of the course but not the current one. A compliant learning management system tracks all the versions of the course automatically.
By offering compliance-related functionality, an LMS helps healthcare and other organizations to -
•	Respond to opportunities and challenges quickly and efficiently.
•	Streamline assignment of all regulatory and job-specific training
•	Create better audit trails
•	Align learning and compliance training to business processes
Thus, by adopting the use of a 21 CFR Part 11 compliant LMS, an organization can:
-	Ensure compliance with the necessary norms framed and mandated by regulatory bodies from time to time
-	Train their employees to ensure compliance with the regulatory framework during everyday work
-	Demonstrate to auditors that they have been conscious about ensuring compliance with various regulatory guidelines
-	Build greater trustworthiness around the brand.