Everything You Need To Know About Learning Management Systems For 21 CFR Part 11

Viren Kapadia Jun 13, 2019
Everything You Need To Know About Learning Management Systems For 21 CFR Part 11

FDA 21 CFR Part 11 LMS Validation is very important for industries where compliance and operational requirements are mandatory. However, not all the business managers in these industries understand the importance of Learning Management Systems (LMS) that comply with 21 CFR Part 11 regulation.

So, if you belong to pharmaceutical, food or life science industry and wondering what a compliant LMS actually is, here is everything you must know.

What Is 21 CFR Part 11 Regulation?

Governed by the U.S. FDA, 21 CFR Part 11 is an approved standard for private and government organizations for record keeping, auditing, and electronic signatures. This implies that 21 CFR Part 11 represents criteria under which electronic signatures and records are considered equivalent to paper records and are deemed to be very reliable and trustworthy.

Healthcare providers and life science organizations that fall under the guidelines of 21 CFR Part 11 must be extra cautious when disseminating information through a Learning Management System. They need to make sure that the LMS they choose can be easily configured with the requirements of Part 11. With this, you can make sure that the training records are always ready for inspection and up-to-date. So, you save a huge amount of time that might be otherwise wasted collecting all the training records and checking if they are up-to-date.

Why Organizations Prefer Part 11 Compliant LMS?

Known to align learning and compliance training to business processes, regulation compliant learning management systems are highly preferred by organizations due to the following major reasons:

  1. Training regarding new SOPs: 21 CFR Part 11 requires personnel to work according to standard operating procedures, or written instructions. Hence, whenever the existing SOP is updated, or a new SOP is introduced, training becomes very important. This is where LMS comes into play. It helps in scheduling as well as tracking the training progress of individuals on SOPs.
  2. Electronic training records: Instead of using paper-based records, organizations can keep electronic records of training via LMS, which is easy, efficient and time-saving. Hence, most of the organizations prefer the latter option over the former.

    Here are major reasons why:

    • LMS generates a training plan automatically, unlike the manual process.
    • An electronic training plan can be easily accessed by the personnel.
    • LMS automatically records who has been assigned to a training class.
    • To analyze the progress of a particular learner, one can easily print a report.
    • The LMS is always updated.

Benefits of 21 CFR Part 11 Compliant LMS

  • Manages courses, instructors, sessions and learners.
  • Streamlines assignment of all regulatory and job-specific training.
  • Tracks individual certifications.
  • Maintains a repository of knowledge assets.
  • Deliver audit reports.
  • Pre-assign training content.
  • Comply with stringent federal and international regulations with secure audit-trail verification and employee training records.

Key Features of Learning Management Systems For 21 CFR Part 11

The major features of regulation compliant LMS are mentioned below:

  1. Electronic Signature

    Three parameters of e-signature (user ID, password, and update meaning) appears 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. Hence, you can rest assured 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 the 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 do the same.

  3. Auditing

    Any changes made to the sensitive data or training materials are recorded in the database. These changes are then audited as to what type of change 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 for auditing 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. One, having access to compliance reports sections can view different audit reports, like the Audit Trail Report and Audit Trail User Action Report.

There are different types of eLearning solutions available in the market. Hence, finding the one for you might not be a strenuous task, for sure. However, finding the right option might not be easy. So, analyze your needs first and then look for a regulation compliant LMS in the online marketplace.