SimplerQMS comes with templates and procedures that are ready to use in your life science start-up or we can migrate your existing QMS. In this way, we minimize the time and effort needed on your end.
Our onboarding-team will get you up on running fast - no matter if you are starting from scratch or already have a QMS in place.
From garage-startup to established company
Whether you are an early start-up or have products on the market SimplerQMS covers your needs. Our pre-defined processes are compliant with the requirements of the FDA and the European Union notified bodies. This enables you to focus on your core processes.
Our implementation process is based on 30+ years of Life Science and Regulation experience. We are strong believers in best practice industry processes. However, we know that every company and product is different. Therefore, we work with you during an online design workshop to understand your business rules, workflow, existing documentation and templates.
The training course provides your team with the skills and expert knowledge required to run your operations.
Before go-live we recommend that an audit is conducted with the purpose of an independant check of regulatory, QMS and planned project activity completeness. An audit report will summerize the conclusions, which is your first line of defence during an inspection.
SimplerQMS is worlds first and only ISO13485:2016 Certified eQMS vendor. We deliver a preconfigured Quality Management System and a validated Part 11 compliant Document Management System for managing your Quality Handbook and Design History File efficiently and digitally.
Our solution is fully validated, under change control and runs on a qualified data center - ready for regulatory audits and inspections.