The Atlantic KET Med QMS is available to download free of charge
Published on 11/04/2022
Bionow is a Partner in the
Atlantic KET Med Project which is now drawing to a close. The AKM Project established a pilot manufacturing ecosystem for future biomedical products, and developed a templated GMP Quality Management System which was used to document 25 technical developments across 10 SMEs who were closely engaged.
There are many benefits in the early adoption of a QMS and there is an
article on the AKM website which explains how the AKM QMS has been successfully used by SMEs within the AKM project. The article includes links to various resources to help you get started, including the recordings of three webinar training sessions and associated materials.
There is also a button at the end of the article to download the entire templated QMS for your own use. You are free to use these template documents to create your own QMS, editing the procedures and templates as necessary. The Atlantic KET Med QMS provides all the necessary documents and structure but will need to be adapted to your own specific requirements.
Given the complex regulatory requirements for GMP compliance, we strongly advise that you enlist assistance from a quality expert to help you with formal implementation of your QMS.
The AKM QMS was built by Alastair Clarke of Weaver Technical Solutions, a Member of Bionow, and he can be reached at
alastair_clarke@lineone.net.
Should you decide to deploy the QMS within your business we would be grateful if you would pass on any feedback to
ian.mccabe@nuigalway.ie at the National University of Ireland, Galway (NUIG), the Lead Partner of the AKM Project
. Your feedback on the QMS and how it supports your business would be very helpful and a valuable additional outcome for the Atlantic KET Med Project.