June 3, 2024 

• The Challenge

In a highly regulated environment such as the pharmaceutical industry, compliance with quality standards and regulations is crucial. An important aspect to consider for compliance is the training of employees to ensure that errors in operational processes are minimized. In particular, global cloud-based HR management systems are becoming the focus of companies for a standardized HR strategy in corporate development.
GxP-regulations require that all electronic systems that can affect the quality or integrity of products have to be validated. Since training and qualification can have a direct impact on product quality, an LMS must be validated in a GxP-regulated environment to ensure compliance with these regulations. Therefore, an important aspect of HR management is the education and training of employees, realized through a Learning Management System as part of an HR Management System.

• Inconsult's support for a LMS Validation

At Inconsult, we understand the requirements and challenges associated with validating an LMS in a GxP-regulated environment. As a partner in the medical technology and pharmaceutical industry, Inconsult supports one of the world’s leading manufacturers of medical devices and pharmaceutical products during the implementation and validation of a Learning Management System on a global scale. Inconsult's end-to-end project support during the initial implementation and local rollouts ensures a successful transition to a standardized and global LMS. The emphasis lies in the creation of validation documents and thus compliance with Good Manufacturing Practice (GMP), alongside providing daily consulting and customized trainings of project participants and employees. These services greatly contribute to the successful validation of an LMS.

Our team of experts supports you in every step of validation and migration processes, from defining requirements and conducting tests to training employees in compliance and validation. We offer customized solutions to ensure that your LMS meets the highest quality standards and fully complies with regulatory requirements.

• Contact

Contact us today to find out more about how we can help you validate your LMS. Our expert Dr. Thomas Walter will be happy to help you.