Iperion, a leading provider of information systems, cloud computing and consultancy services for the life sciences industry, and NetDimensions, a global provider of performance, knowledge and learning management systems, announced today a global partnership to offer NetDimensions Learning in a GxP-compliant cloud environment for the life sciences industry.
Compliance with GxP regulations (such as 21 CFR 210 or 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 computerized systems is mandatory for regulated life sciences organizations. Therefore, validation of an organization’s Learning Management System (LMS) — as part of the overall Quality Management System — is not optional; it is an integral part of the organization’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 specialized, 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 organizations 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 and to be flexible and fast to meet our clients’ needs,” said Karel Bastiaanssen, CEO of Iperion.
With more than 3 decades of experience in the life sciences industry, IPERION® has been recognized for its dedication in quality management and delivery of high quality systems & services in life sciences.
The company is specialized in information systems, consultancy and GxP Cloud Computing that ensure compliance. IPERION® operates in the pharmaceutical, medical devices, biotechnology and health care sectors. The head office is located in Vlijmen, the Netherlands and its facilities are established in both Europe and the US.
IPERION® serves its customers to fulfill the high demand to acquire the best available, custom-made information system that integrates processes and industry standards. Furthermore, data security and data integrity is the focus for our GxP cloud computing solutions when it comes to information technology.
IPERION® is ISO27001 and ISO 9001:2008 certified.
For further information on IPERION® systems and services, please visit www.iperion.nl