ENSUR

SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including 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. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.

Specialists With a Trusted Solution for Document Control and Specification Management. Store your critical business documents in a secure, centralized repository where you can automate company-wide workflows and manage revisions, review and approval routing, electronic signatures and more. Digitize your specifications in a centralized system where you can easily structure, manage and share your specs and data, minimize human error and gain visibility across your product lines. Many organizations struggle with these inefficiencies as a result of manual, paper-based or homegrown document management systems. The power of a document management system is in its ability to simplify complex manual processes like document revisions, review and approval workflow, change control, and the distribution process. The ENSUR document management system streamlines these processes for you by automating your document workflows, minimizing employee errors and increasing overall company efficiency.