What Is a Validated LMS?

You may have heard the term “validated LMS” being thrown around when it comes to various types of platforms. This is an industry-specific term that’s applied to organizations with certain requirements for compliance and other protocols.

Does your organization manufacture food, drugs, medical devices, or anything chemistry-related? You might want to pay close attention to this article if they do.

The term validated LMS applies to any organization that emphasizes regulatory compliance. Understanding what a validated LMS consists of is crucial because these compliance elements can dictate an organization’s existence within the previously mentioned industries.

Are you aware of what defines a validated LMS? Continue reading to find out.

FDA Regulation

Certain industries are considered high-risk by the FDA. The industries mentioned earlier (food, drugs, medical devices, chemistry, biosciences, etc.) make up the majority of these industries.

These high-risk industries are subject to strict rules and inspections at the hands of the FDA. These rules bind any company that manufactures food, pharmaceuticals, or medical equipment.

The  GMP (Good Manufacturing Process) and GCP (Good Clinical Practice) guidelines are processes that must be applied to the production of any products that fall under the categories mentioned above. Basically, these guidelines outline the safest and most efficient manufacturing methods and ensure the safety and protection of consumers who buy these items.

Things like keeping a safe manufacturing environment, using only approved ingredients, and selling equipment that passes industry standards are highlighted in these guidelines.

This is what is known as regulatory compliance, and every company that exists in these industries must be able to produce proof of its compliance. Additionally, they must also show undeniable proof that they’ve trained employees in the importance of regulatory compliance and the relevant procedures for the manufacturing process.

Proof of adhering to these regulations is obtained during inspections and a log that tracks a certain manufacturing process. Providing proof of the proper training standards means keeping track of hours logged by employees in training and providing copies of all certifications upon course completion.

Adhering to Standards

Certain production methods are critical for creating safe and effective products when it comes to the pharmaceutical, food, and medical manufacturing industries. This means every employee must participate in detailed and rigorous training that outlines all of these manufacturing and production requirements.

In 21 CFR Part 11, the FDA states its requirements for manufacturers of pharmaceutical and medical products in relation to record-keeping. All records that are accessed electronically in any form must either be texts, images, videos, or audio files.

All files must have information included that explains how the attached files fulfill the requirements outlined by the FDA.

How does your LMS come into play here? Your LMS ensures that your organization is not only hiring the right people but also providing relevant, critical, and timely training to cover a broad range of topics.

Here are some of the most popular SOPs in the life sciences industry:

1. Document Control and Management

These SOPs outline the processes for creating, reviewing, approving, distributing, revising, and archiving documents. It ensures that documents are controlled and managed effectively throughout their lifecycle, maintaining their integrity and confidentiality.

2. Quality Assurance and Quality Control

These SOPs detail the procedures for maintaining quality standards in production and laboratory environments, including the management of deviations, CAPA (Corrective and Preventive Actions), and quality audits. They help in ensuring products meet required specifications and regulatory standards.

3. Equipment Qualification and Maintenance

These SOPs cover the processes for the qualification, calibration, maintenance, and cleaning of equipment. They ensure that equipment is operating correctly and producing accurate results, which is crucial for maintaining product quality and safety.

4. Validation Procedures

Validation SOPs describe the processes for validating methods, processes, and systems to ensure they perform as intended. This includes validation of manufacturing processes, cleaning procedures, analytical methods, and computer systems.

5. Laboratory Operations

Laboratory operation SOPs provide guidelines for safely conducting laboratory tests and experiments. This includes procedures for sample handling, data recording, reagent preparation, and waste disposal to ensure accurate, reliable results and safety in the laboratory environment.

6. Data Integrity and Management

These SOPs focus on ensuring the accuracy, completeness, reliability, and consistent intended use of data. They cover the processes for data collection, processing, analysis, and archiving, adhering to principles like ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate).

7. Training and Competency

Training SOPs outline the procedures for training staff and assessing their competency. This includes new employee orientation, ongoing training programs, and evaluations to ensure that all personnel are capable of performing their duties effectively and in compliance with regulatory standards.

8. Clinical Trial Management

For organizations involved in clinical research, SOPs related to the management of clinical trials are crucial. They cover various aspects of clinical trial conduct, including patient recruitment, informed consent, trial monitoring, and reporting of adverse events, in compliance with Good Clinical Practice (GCP) guidelines.

9. Environmental Monitoring

These SOPs describe the procedures for monitoring and controlling the environment in manufacturing and laboratory areas. This includes monitoring of temperature, humidity, particulate matter, and microbial contamination to ensure that environmental conditions do not adversely affect product quality or safety.

10. Handling of Complaints and Recalls

Procedures for managing customer complaints and product recalls are detailed in these SOPs. They outline the steps for investigating complaints, determining recall necessity, conducting a recall, and reporting to regulatory authorities, ensuring prompt and effective resolution of potential product quality or safety issues.

This is what makes your LMS platform subject to certain FDA codes. These codes include 21 CFR Part 11. The CFR stands for the Code of Federal Regulations, which is the portion that makes these regulations industry-wide on a national level.

Because of your LMS’s data and progress-tracking abilities, these systems are specifically designed to fulfill these demands for proof. However, in order for your system to become validated and recognized as an efficient source of proof, it must meet certain requirements.

The following section outlines these requirements.

How Your LMS Meets Validation  Standards

In an effort to minimize human error, the FDA requires any system used in the production or education process to be validated and perform visible functions of the said validatable system.

Audit Trail

All data must be traceable and automatically logged in the required format. Additionally, all of this information must be able to be exported. Any changes, planned courses, and course registration are logged using audit trails. Any defined roles and rights must clearly be stated, and what was changed and who changed it, and the format in which the changes were adapted must be logged as well. See how eLeaP’s audit trail works.

Electronic Signature

An electronic signature may also be required whenever certain actions are performed. Furthermore, these actions must only be carried out by authorized personnel identified by the audit trail, and a login ID and password validate the authorization. Things like the approval of tests and registering approved learning content must be authorized and validated.

Versioning

Any training content that’s included on your LMS platform will be subject to version control. This includes entire courses, course templates, specific learning paths, test questions, certificates, and cost types. Whenever any of these characteristics are edited, the most recent version will be stored in the system as numbered versions and formally published. All previous versions are also permanently stored, ensuring they can never be lost. This allows for a permanent tracking of all changes made to any of these objects.

Once all of these requirements are met, the validation process must be used to carry out a risk analysis for all products and functions, including the entire LMS itself. Certain scenarios are considered. Note the following example:

What happens if a person accidentally pushes button Z when button Y is the appropriate action? What potential errors can arise, and what is the impact of these errors? What risks or dangers do these errors pose to patients or consumers?

This is best described as a test of worst-case scenarios and weighing the “what if” factors. However, this analysis is only successful, traceable, and verifiable if the roles, processes, and rights are clearly defined and visible.

Once all of these requirements are met, your LMS platform earns the label of a validated platform and is officially legal for use in your specific industry.

All of the previously mentioned areas of importance and the overall theme of regulatory compliance highlight the importance of a validated LMS and its cemented place within the food, pharmaceutical, and medical industries.

Although these processes may seem excessive, they are absolutely warranted. After all, when it comes to the health and safety of consumers, there truly is no room for human error.

Contact us today for a free consultation to ensure your platform is validated and meeting regulatory compliance requirements!