OUR eQMS - Your solution

Start ups and small companies need efficient and cost saving solutions.

If you plan starting your own business with exist, BMBF or BMWi grants... - If you aim on improving your existing business... - if you need a base to re-scale your companies quality management system... - You can profit from our electronic Quality Management System.

 

We especially adress small and mid size companies, but also bigger companies can profit from our know how and special approaches.

 

Our eQMS is cloud based with many benefits:

  • Electronic signatures according to 21 CFR Part 11 and extended electronic signatures according to eIDAS
  • Decentral company design possible
  • Agile workflow
  • Usage and archiving of existing records

Included:

  • Setup and initial validation of a Confluence Cloud - Instance owned by you
  • Implementation of eQMS with quality-manual, quality- and risk-policy, 26 QMS-procedures with 78 templates - ready to use
  • Implementation and training of users

We work according to international regulations:

  • Regulation 2017/745 (MDR)
  • EN ISO 13485:2016
  • 21 CFR Part 820, Part 11, ...
  • MDSAP, ...

With us you will get optimal support to optimize your quality management system the right way - efficiency without waste of resources.

 

Contact us for a personal demonstration.