Medicine surrounds a mobile device
Validation
GxP-compliant training in the LMS
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Rethinking validation

GxP-compliant training with a validatable learning management system

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Security and traceability 

With audit trail and versioning, you are always in a position to trace all processes in the LMS.

 

 

 

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Maximum efficiency with minimal input

Save time and costs with an extensive set of documents provided by imc

 

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Compliant hosting of Title 21 CFR Part 11

The validated LMS runs in the MS Azure cloud which satisfies the requirements according to Title 21 CFR Part 11

 

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Competent support and advise throughout the entire project

Many companies – for instance, in the pharmaceutical or medical sector – need to satisfy strict regulatory requirements such as FDA Title 21 CFR Part 11. This includes that all processes leading up to the production of a product are documented and can be verified at any time. That also applies to employee training, in itself an essential element of quality management.

 

Sounds cumbersome? Well, it is. Validation is a highly complex topic, and it often costs a lot of time and money. This is why we are supporting our customers with a fully validatable learning management system while also offering guidance throughout the project.

 

Easily master software releases

Complex validation requirements lead to high costs for testing and documentation. Every time a software release is delivered, cloud or otherwise, the company needs to invest a lot of time and money to implement any changes. In cloud environments where multiple releases occur quarterly, this is nearly impossible. We are therefore offering validated customers a release schedule with two annual updates.

 

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Maximum efficiency with minimal input through extensive document set

To support the validation of the LMS, we document setup in the cloud as well as the overall configuration of the system. We also provide evidence that all the necessary steps for the proper installation of the environment have been followed. We want to help you comply with the mandatory documentation for initial validation. To this end, we are offering an extensive set of documents containing all documents required to validate the learning management system: functional requirement specification, user requirement specification, IQ, OQ, PQ, risk assessment, change control, traceability matrix and a validation plan. In addition, extensive documentation in accordance with the validation requirements is provided with each release. This also includes an installation and test report.

 

Medicine surrounds a mobile device

Interesting facts on validation

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Guide

We show you what to take into account for the validation of your LMS, and how LMS providers can support you.

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Article

Read here, which requirements an LMS must map for validated processes.

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Get to know our learning management system. 

 

 

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CONTACT US

Discover validation for your corporate success

Are you interested in validation with the imc Learning Suite? We are happy to advise you without obligation in a consultancy meeting.

FAQ

What is validation?
  1. Validation means furnishing proof that a process permanently produces a product according to specifications and quality standards with a high degree of assurance.
  2. Validation of a computer-based system means the documented proof that the system satisfies the regulatory requirements, and that it currently works as required according to the specifications and will continue to do so in the future.

[Source: FDA Guidelines on General Principles of Process Validation]

Does my organisation need a validated LMS?

A validated LMS offers great advantages primarily for companies that manufacture food products, medicines and medical devices in general. But validation can also be useful in some other cases. Contact our experts to learn more.

What are GxP guidelines?

GxP guidelines include GMP and GCP guidelines, which relate to the correct processes (Good Manufacturing Practice: GMP) and Good Clinical Practice (GCP) that must be applied in the production of medicinal products and substances.

What is the FDA and who is affected by the requirements?

As a government agency under the U.S. Department of Health and Human Services, the FDA imposes strict rules on companies that manufacture food products, drugs and medical devices in general. All companies offering their products and produce in the USA are bound by these rules. In addition to the FDA, the European Medicines Agency (EMA) also enacts such rules through the EU. This also includes good practice guidelines (GxP).