xLM Platform includes both the QMS (Quality Management System) and the Technology Stack which together deliver the Managed Service.
Quality Management system (QMS)
xLM QMS is based on industry standards as well as applicable GxPs. xLM QMS is a robust framework based on ISO 9001:2015, GAMP 5 and ASTM E2500 as well as FDA 21 CFR Part 11, EudraLex Annex 11.
xLM's QMS enables us to deliver our managed services that not only meets, but exceeds the expectations of regulatory agencies in the USA, Europe and Japan.
xLM's technology platform is managed under the QMS. The technology platform includes the IT Infrastructure as well as software applications and tools. xLM's technology platform is qualified and each instance used to deliver managed services is validated.