Qualcy

Qualcy is an AI-based Quality and Regulatory Intelligence Platform designed specifically for biotech and pharmaceutical companies. The platform delivers comprehensive regulatory compliance solutions through a unified system that spans document control, FDA compliance, quality management, and AI-powered regulatory change monitoring. All products are built to meet ISO Standards and 21 CFR compliance requirements, and the entire platform is 21 CFR Part 11 compliant.

Qualcy offers customers the flexibility to start with a single module or deploy the full platform at once. The company emphasizes customized solutions tailored to each customer's unique needs, with a strong focus on user-friendly design that makes transactions easy to understand and execute.

Core Products and Modules

• Document Control: Ensures only current documents are available to users, supports review and approval of changes, enables efficient document search and access, and maintains compliance with ISO standards and FDA regulations including 21 CFR Part 820 for medical devices.
• Calibration Management: Manages calibration schedules and reports, provides notifications and monitoring for past-due calibrations, supports creation and assignment of work orders with status tracking, and retains calibration and maintenance records.
• Audit Management: Facilitates easy audit planning and simplified execution workflows, tracks and follows up on audit plans, automatically releases audit reports and non-conformances upon report approval, and sends reminders to reviewers and task owners.
• Training Records: Supports assignment of training on an as-needed basis or automatically through the change control system, documents training completion and records, ensures compliance with applicable regulations and standards, and provides reminders for overdue training items.
• Regulatory Intelligence (RI) Management: Qualcy RIM (Regulatory Intel Management) provides a simple interface for managing AI-powered regulatory intelligence for pharma and biotech companies, enabling organizations to stay ahead of regulatory changes and take proactive actions.
• Risk Management: Qualcy eQMS offers a straightforward interface for managing risk management processes in compliance with ISO 14971:2019 and other regulatory bodies including the FDA, EU MDR, and Health Canada.
• Design Control Management: Qualcy eQMS provides a simple interface for managing the design control process for medical device applications, supporting structured development and documentation workflows.

Compliance and Platform Highlights

• Full 21 CFR Part 11 compliance across all products.
• Designed to meet ISO standards and FDA regulatory requirements, including 21 CFR Part 820 for medical devices.
• Risk management module compliant with ISO 14971:2019, FDA, EU MDR, and Health Canada requirements.
• AI-powered regulatory change monitoring to support proactive compliance management.
• Unified platform allowing modular adoption or full deployment.
• Customized solutions offered to address each customer's unique compliance environment.

Qualcy's platform is purpose-built for life sciences organizations seeking a scalable, compliant, and intelligent quality management solution that reduces regulatory risk and streamlines operations across the product lifecycle.