Grand Avenue Software
A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.
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SimplerQMS
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.
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Ideagen Qadex
Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met.
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ARMATURE Fabric
With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities.
Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders.
Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends.
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