Intellect QMS $1.000

Intellect: Customizable Quality Management Software (QMS) for Regulated Industries

Intellect is a highly customizable Quality Management Software (QMS) platform designed to help businesses in regulated industries such as life sciences, manufacturing, automotive, aerospace, and pharmaceuticals streamline quality processes, ensure regulatory compliance, and improve overall efficiency. The platform offers a wide range of tools for managing document control, CAPA (Corrective and Preventive Actions), nonconformance, audit management, and supplier quality, all within a flexible, no-code environment that allows organizations to tailor the system to meet their unique needs.

Intellect’s platform is cloud-based and supports compliance with industry standards like FDA 21 CFR Part 11, ISO 9001, ISO 13485, ISO 14001, and ISO 45001. It helps organizations improve product quality, reduce risk, and accelerate time to market by automating and simplifying quality management processes.

Key features of Intellect include:

Customizable Quality Management System (QMS): Intellect allows businesses to tailor their QMS to fit specific operational needs using a no-code platform. This means users can configure workflows, forms, and reports without the need for programming skills, enabling greater flexibility and rapid deployment.
Document Control: Intellect’s Document Control module provides a centralized location to store, manage, and track all quality-related documents. The system ensures version control, audit trails, and secure access, making it easy to maintain compliance with regulatory standards.
CAPA Management: The platform automates the Corrective and Preventive Actions (CAPA) process, enabling teams to identify, investigate, and resolve quality issues efficiently. With full traceability and audit trails, the CAPA module helps ensure compliance with industry regulations like ISO 13485 and FDA 21 CFR Part 820.
Audit Management: Intellect streamlines the audit process by allowing organizations to plan, schedule, and execute audits across the enterprise. The system provides real-time visibility into audit findings and enables the creation of audit reports, ensuring that all nonconformities are properly documented and addressed.
Nonconformance Management: Intellect’s Nonconformance module helps organizations track and resolve product or process nonconformities in real time. The system ensures that all nonconformances are investigated, documented, and closed out according to regulatory requirements.
Risk Management: Intellect offers comprehensive risk management tools to assess, mitigate, and monitor risks throughout the product lifecycle. The platform helps organizations comply with ISO 14971 for medical device risk management by integrating risk assessments into quality processes.
Supplier Quality Management: The platform includes supplier quality management tools to track and evaluate supplier performance. Intellect allows users to manage supplier audits, qualifications, and corrective actions, ensuring that suppliers meet quality standards and regulatory requirements.
Training Management: Intellect offers a Training Management module that tracks employee training and certifications to ensure compliance with industry regulations. The system helps organizations document training activities, manage employee competencies, and maintain readiness for audits.
Change Management: The Change Management module enables companies to manage product and process changes in a controlled manner, ensuring that changes are reviewed, approved, and implemented in compliance with regulatory requirements. Full traceability and audit trails are provided to document every step of the change process.
Audit Trails and Compliance: Intellect ensures full traceability with detailed audit trails for all quality processes, including document changes, CAPA actions, and training records. The system is compliant with FDA 21 CFR Part 11, ensuring that all electronic records and signatures meet regulatory standards.
Mobile Access: Intellect offers mobile capabilities, allowing employees to access quality management processes from any device, ensuring real-time collaboration and faster decision-making, whether in the office or on the production floor.
Post-Market Surveillance: For industries like medical devices and pharmaceuticals, Intellect provides tools for tracking product performance after it has entered the market, ensuring continuous improvement and compliance with post-market regulatory requirements.
Analytics and Reporting: The platform provides robust reporting and analytics tools that enable organizations to generate custom reports, track key performance indicators (KPIs), and gain real-time insights into quality processes. This helps teams make data-driven decisions to improve quality and compliance.
Key Benefits:
- Highly customizable QMS with no-code configuration for tailored workflows.
- Comprehensive document control with versioning, audit trails, and secure access.
- Automated CAPA and nonconformance management for efficient issue resolution.
- Risk management tools that align with ISO 14971 for medical devices.
- Supplier quality management for tracking performance and ensuring compliance.
- Training management to track employee competencies and regulatory readiness.
- Change management with full traceability and regulatory compliance.
- Mobile access for real-time collaboration and quality process management.
- Full compliance with FDA 21 CFR Part 11, ISO 13485, ISO 9001, and more.