SimplerQMS
SimplerQMS is a Quality Management Software tailored to the needs of Life Science companies. Our cloud-based, fully-validated solution simplifies and streamlines workflows, allowing life science companies to stay compliant with regulatory requirements such as FDA 21 Part 11 and EU Annex 11, GxP, GAMP5, EU MDR and IVDR, ISO 13485, FDA 21 CFR Part 820, and more. Our QMS Software includes all Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaint Management, Nonconformance/Deviation Management, CAPA Management, Audit Management, and many others are provided in one complete QMS solution.
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SimplerQMS Introduction
What is SimplerQMS?
SimplerQMS is a cloud-based Quality Management System (QMS) software designed to help Life Sciences organizations streamline their quality processes, enhance regulatory compliance, and improve operational efficiency. SimplerQMS solution is particularly suited for small to medium-sized businesses in highly regulated industries, such as pharmaceuticals, biotechnology, medical devices, MedTech, in-vitro diagnostics (IVD), and contract research organizations (CROs). By automating key quality management functions, SimplerQMS enables companies to handle document control, change management, training, many other processes, and compliance more effectively. Main Features and Benefits: - Regulatory Compliance: SimplerQMS supports compliance with essential Life Science requirements, such as GxP, ISO 13485:2016, FDA 21 CFR Parts 210, 211, and 820, ICH Q10, EU MDR, IVDR, ISO 9001:2015, and many others, helping companies meet stringent requirements. - Automated Document Management: Streamlines document creation, review, and approval processes to improve efficiency and reduce time spent on administrative tasks, including workflows for controlled documents like SOPs and validation reports. - Comprehensive QMS Processes: Integrates various quality processes essential to Life Sciences, including Non-conformance/Deviation Management, CAPA (Corrective and Preventive Action) Management, Complaint Management, Risk Management, and Supplier Management, among others. This ensures a unified approach to quality and compliance. - Secure Cloud Infrastructure: Built on Microsoft Azure and M-Files technology, SimplerQMS offers enterprise-grade data security with encryption during storage and transmission, regular data backups, and global data storage options to safeguard data integrity. - Seamless Integrations: The software supports integrations with Microsoft Office 365, enabling users to work directly in familiar applications like Word and Excel. Additionally, SimplerQMS can be integrated with ERP, PLM, CRM, and other business systems, enhancing operational cohesion and data flow across departments. SimplerQMS is designed for regulated industries needing a robust and compliant QMS solution that adapts to a variety of quality and operational workflows while supporting secure data handling and regulatory alignment.
How to use SimplerQMS?
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Why Choose SimplerQMS?
You should pick this if you’re in the Life Sciences field and need a cloud-based QMS that helps you stay compliant with tough regulations while simplifying your quality management processes.
