What is an eQMS (Electronic Quality Management System)?

What is an eQMS (Electronic Quality Management System)?

Electronic Quality Management System (eQMS) Definition An Electronic Quality Management System, or eQMS, for short, is a new digitalized approach to a Quality Management System (QMS). An eQMS is software that helps manage and document business processes for product...
What is M-Files QMS?

What is M-Files QMS?

M-Files QMS is a document management technology, which is used by SimplerQMS to build a ready-to-use eQMS Solution for the Life Science Industry.  M-Files was founded in 1987 and over the course of 30 years, they have been developing, tweaking, and testing their...
FMEA vs Hazard Traceability Matrix in ISO 14971

FMEA vs Hazard Traceability Matrix in ISO 14971

It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...