Why an LMS should implement FDA 21 CFR Part 11 Compliance?

The part 11 of the title 21 of the Code of Federal Regulations (CFR), or 21 CFR Part 11 Compliance as commonly called, sets the terms in which electronic records and electronic signatures are considered reliable, safe and comparable to physical records. Companies in the pharmaceutical and food industry must ensure that their LMS or eLearning Platform complies with the features that the Part 11 regulation required.

In order to comply with those regulations, the eLearning software needs to have a safe and reliable management of all the registered information and the right storage of activities and processes that create a validated LMS.

Paradiso Solutions offers the most reliable, safe, fully featured and cloud-based LMS software for training or teaching purposes. Our system could not only be compliant with the 21 CFR Part 11 regulation, it complies also with SCORM 1.2, SCORM 2004 and Tin Can API, making our product a robust system that will help you achieve all the learning goals.

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Some of the main benefits of 21 CFR Part 11 compliance on LMS

  • Guarantees the availability and trackability of any record or activity
  • Promotes the quality commitment on the company and customer safety
  • Enhances the experience with the products and services for customers

  • Creates a validated Learning Management System and a regulated environment
  • Makes it easy to elaborate, check or approve documents
  • Minimize efforts for compliant standards like FDA, ISO, among others
  • Helps to avoid the use of duplicate or out of line content. Limits the access to only active content avoiding detours

Features required to be a FDA 21 CFR Part 11 compliant LMS


Every change made in the platform needs to be tracked in the LMS database. There you must have all the information related to the change and the time when it was made. Those changes include creation, updating, and deletion of sensitive data.

Electronic Signatures or eSignature

Electronic Signatures or eSignature

An E-signature is required before every important operation in the platform. The feature should ask for an ID, password and the reason to update the information. This creates a very complete solution to keep control of your E-Learning System.

Electronic Storage Capability

This must be a constant recording feature for a proactive compliance reporting. A good system of electronic storage allows the inspection process of an LMS to be effective and efficient.

Electronic Storage Capability
Version Control

Version Control

The LMS needs to have an electronic training records with constant updates with the exact version of each course taken.

Reports Generator

The audited data requires to be shown as reports like the Audit Trail and Audit Trail User Action. This gives users the possibility to access the audited information in formats like PDF, Excel, HTML or CSV.

Reports Generator
Secure Hosting

Secure Hosting

The eLearning software must guarantee a secure and reliable hosting environment for all the information stored in the platform.

Paradiso makes the world’s Best eLearning Software

Of all the countless eLearning solutions available in the market, how would you choose the best eLearning software that fits exactly your eLearning needs? It’s simple! When you’re going to buy an LMS consider these 4 points – Utility, Price, Maintenance and Mobile Compatibility.

If your chosen eLearning software checks these 4 features, give it a chance. In Paradiso LMS you can get those features and much more! You’ll get the best value for your money, combined with an easy to use, feature-rich and multi-device friendly platform.

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