Compliance with GxP regulations (such as 21 CFR 210 and 21 CFR 820) in combination with the electronic records and electronic-signatures rules (such as 21 CFR Part 11 or EU GMP Annex 11) for computerised systems is mandatory for regulated life-sciences organisations. Therefore, validation of an organisation’s learning-management system (LMS) — as part of the overall Quality Management System — is not optional; it is an integral part of the organisation’s compliance infrastructure.

NetDimensions Learning has been part of client validations for meeting the requirements of FDA’s 21 CFR Part 11. Now, for the first time, NetDimensions is offering NetDimensions Learning in a GxP-compliant cloud environment, available to clients who want to take advantage of NetDimensions’ ISO 27001:2013 Secure SaaS model in highly regulated industries such as life sciences.

"Now, in partnership with IPERION, NetDimensions is able to provide its specialised, fit-for-purpose Secure SaaS, offering to clients who require systems that run in a qualified, GxP-compliant environment. IPERION’s GxP cloud-platform infrastructure is qualified in line with the GAMP Good Practice Guide: IT Infrastructure and Compliance. NetDimensions Learning hosted in IPERION’s GxP-compliant cloud-computing environment will enable organisations in the life-sciences industry to access our award-winning LMS, while meeting global regulatory requirements," explained Ray Ruff, Chief Scientist and co-founder of NetDimensions.

"The IPERION cloud-computing solution supports companies that want to leverage on the advantages of the cloud, while at the same time have to comply with the stringent regulations of the life-sciences industry. Partnering with NetDimensions is an excellent example of how two leading suppliers complement each other to find the optimal solution for fulfilling the specific needs of pharma, biotech, and medical-devices companies. Our datacenter is fully compliant with the life-sciences industry regulations and managed by ourselves, which gives us the advantage of being compliant, as well as flexible and fast to meet our clients’ needs," said Karel Bastiaanssen, CEO of Iperion.