SimplerQMS

SimplerQMS offers a cloud-based Quality Management Software tailored to the needs of the Life Science industry. The QMS platform supports compliance with requirements such as FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others.

Various Life Science QMS modules are integrated, including Document Management, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, and Risk Management.

SimplerQMS enables users to work with documents in Microsoft Office applications such as Word, PowerPoint, and Excel. Users can modify documents directly through the Microsoft Office interface and save them in the cloud with just one click.

SimplerQMS ultimately aims to provide efficient, paperless workflows that support compliance with requirements in the Life Science industry.