ZenQMS is an electronic, cloud-based quality management system we are implementing to achieve GMP-level compliance with regard to document control and overall data integrity.
Why did we need this system? Until now, we’ve utilized a manual quality control system which has served us well over the years. However, since we are never satisfied with status quo, we decided to implement an electronic quality management system which is considered the ‘gold standard’. In order to level-up our QMS, we needed to put processes into place to help us manage all activities required to comply with FDA, cGMP and ISO regulations. We set our sights on ZenQMS who offers a cloud-based QMS to help improve document/record control and facilitate process workflows. Once in place, ZenQMS will also help us reduce the associated regulatory risks.
What will it help us accomplish? Making ZenQMS part of our quality management plan will help us stay afloat in today’s complex regulatory environment, helping us sail through inquiries and audits. This built-in automation which becomes deeply embedded into our company culture will ensure GMP-level management of documents, records, training, process workflows, audits, and non-conformities/change controls/ deviations etc. This will both directly and indirectly lead to the improvement of the quality of our products and processes, which is our ultimate goal.
Why ZenQMS? Many reputable life science companies utilize ZenQMS for their data integrity. We chose ZenQMS for ease of use, length of time required for initial set-up, the level of technical support they will provide, as well as cost-effectiveness. Every employee will utilize the software at some level – users will either be passive or active participants depending on the specific process or workflow.