GxP-compliant training with a validatable learning management system
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.
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.
Interesting facts on validation
Read more about topics, trends & tools around the LMS.
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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.
- Validation means furnishing proof that a process permanently produces a product according to specifications and quality standards with a high degree of assurance.
- 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.
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.
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.
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).