Softek Export LLC operates in a highly regulated environment and also remains in compliance with FDA, cGMP, CFR 21 and other regulatory requirements. As a global leader in Learning Management Systems, we have over 25 years of experience serving regulated industries, which is why we know and understand your needs and challenges.

Working with a validated LMS is essential for remaining compliant with both U.S.- and European Union (EU)-based regulatory bodies, as validation ensures the quality and safety of every new software update. At Softek Export LLC, we follow a strict Software Development Lifecycle (SDLC), which includes thorough testing and verification by our Quality Assurance (QA) department.

The Importance of a Validated Learning Management System (vLMS)

As with many other things in regulated industries, official agencies determine the requirements for software validation to ensure each product is safe, stable and efficient. A validated Learning Management System (vLMS) refers to a system that has undergone installation, operational and performance qualification protocols. To be considered validated, the results of these protocols must be consistent and possible to replicate.

To remain compliant with regulatory requirements, an LMS must be appropriately validated. A vLMS like ISOtrain contains specific features that make it automatically FDA-, GDPR- and EudraLex-compliant. What's more, we designed our system specifically for regulated industries, so your business can be confident that future updates will comply with industry-specific requirements.

There are numerous benefits to using a vLMS to automate your training process. With updated Standard Operating Procedures, your team will enjoy the automation of the learning process for more streamlined qualification paths. A reliable vLMS will also include tracking features that allow your business to assign training courses, monitor employee progress and analyze data on personnel qualifications. These features are essential for passing regulatory audits.

The importance of vLMS goes beyond being convenient. Regulatory bodies in the United States and abroad require Learning Management Systems to be validated to comply with several requirements. These regulations are crucial because they protect users' safety, and ignoring them can result in hefty fines and a damaged reputation. In short, a vLMS is essential for companies that need to train and certify their employees.

Types of Qualifications

Because even the smallest issues can cause serious problems in highly regulated industries, there are many checks and balances to guarantee a new system will function correctly. When it comes to software validation in regulated sectors, three key protocols ensure the program is high-quality, reliable and secure.

Installation Qualification Protocol

When a company designs and distributes a new product, there are specific steps the consumer should follow when installing it to ensure it works correctly. Manufacturers often refer to these steps as an installation checklist, and they're essential for products and systems in pharmaceuticals, medicine, cosmetics and other regulated industries. The installation qualification (IQ) protocol is in place to ensure a company has installed a new system correctly by verifying that they followed the manufacturer's specifications.

Steps the QA department might complete during an IQ protocol include:

Inventory software and assess documentation.

Inventory and verify equipment.

Assess all files required to run the system are present.

Assess the physical placement of equipment.

Verify Backup and Recovery.

Install / Configure operating system and support system software.

Operational Qualification Protocol

Once the IQ protocol is complete, the QA department will move on to the operational qualification (OQ) protocol. This method helps ensure the new system is functional enough for consumers to begin using. During the OQ process, the testing team will review the operating ranges according to the manufacturer and determine if the new system's performance is consistent with the intended user requirements. The system should operate in its new environment according to its original design.

The OQ protocol consists of:

Testing the essential functionalities to ensure the software operates as intended.

Writing tests out step-by-step so that others can understand them and replicate the results.

Creating a checklist that includes configuration values for each test.

Testing the display units and controls.

Performance Qualification Protocol

The final test is the performance qualification (PQ) protocol. The PQ protocol involves testing the software under the workload it will encounter once the system officially launches. During the PQ protocol, the QA Team will perform various tests to ensure the system functions correctly under heavy traffic and with concurrent users. The team will measure response times and check that the system avoids crashing during use.

During the PQ protocol, the testing team will typically:

Check the software is available and avoids going down.

Ensure users can access the software from all of the necessary locations.

Measure how well the system handles heavy traffic.

Test the system to its breaking point.

Why Use ISOtrain Validated LMS

We validate products before they enter the marketplace.

We are managed and audited on SOPs under the direction of a Quality Department. We develop products with a Software Development Lifecycle (SDLC) and validate all products before they enter the marketplace. In addition to pre-validated software, we also provide IQ/OQ/PQ validation protocols packages and validation services support.

We respond quickly with expertise and results.

Whether your challenge is setting up a validation or qualification program, an emergency response to a critical compliance situation, or you need resources to partner with your QA Team, our Quality Assurance Validation Services Team will respond quickly with expertise and results.