Our vision is to be a preferred partner for small life science companies, that focus on high quality and efficient processes.
The SimplerQMS application will often be the first IT-system investment done by start-up’s. We strongly believe that starting with the smallest possible scope, which addresses the biggest needs, is the right approach. At the same time, we are ready to grow with our customers – from the early startup phase to mature post market companies.
With SimplerQMS, life science companies instantly gain the following key advantages:
- Modern secure cloud application running on Qualified Microsoft infrastructure compliant with ISO 9001:2015; ISO 27001:2013 and ISO 27018:2014
- Validated application compliant with ISO 13485:2016; FDA 21 CFR Part 820; FDA 21 CFR Part 11; Eudralex Annex 11 and GAMP5 which ensures you have electronic records and approvals accepted by regulatory authorities e.g. in Europe and USA.
By subscribing to SimplerQMS you:
- Get access to a prize winning best-in-class system credited both by Gartner and Forrester.
- Will run on a system that is easy to learn – based on Microsoft and directly integrated with all the Microsoft Office applications.
- Pay as you go – no initial investment in licenses, free implementation and data migration from legacy system(s).
- Have a virtual application working across time zones and locations, connecting internal staff and enable seamless collaboration with external stakeholders like QA/RA advisors and outsourcing partners used e.g. for research and development, manufacturing, customer service and supply chain. There is no need for complicated integrations. All records are available in one application you control.
- Ensure that everybody have access to what they need but with strict access controls.
Our SimplerQMS application enables you to:
- Manage your key entities as employees, suppliers, customers, equipment, products and projects through electronic approval flows
- Manage versioned templates
- Establish key value lists based on your own data: Departments, processes, archives and datatypes
- Manage and store all your QMS documents from policies, standard operating procedures, work instructions and forms
- Manage all your quality records in a single system and relate each record to your employees, suppliers, customers, equipment, products and/or projects
- Have the option to export your data and migrate to another system, if you SimplerQMS no longer suits your needs
- Can use prebuild connections to other systems within e.g. ERP, CRM, HRM and supplier invoice management.
- Take advantage of build-in connections between different key-processes and that all records can be created and archived in a single application you control.
We work globally with small life science companies and our mission is to become a key partner for hundreds of these companies over the next years. We know that many of these companies are struggling with manual processes and paper records. Let us help you focus on core business and not on pushing paper. Please contact me directly on +4593901646 or js@simplerqms.com if you want to hear about your options.