QMS

Qualcy eQMS is an AI-based Quality and Regulatory Intelligence Platform designed specifically for biotech and pharmaceutical companies. It delivers comprehensive regulatory compliance solutions through a unified platform that spans document control, risk management, audit management, training records, calibration management, design control, and AI-powered regulatory change monitoring. The platform is built to comply with ISO standards and 21 CFR regulations, and all modules are 21 CFR Part 11 compliant.

Qualcy eQMS is built with flexibility in mind, allowing organizations to start with a single module and expand over time. It is particularly well-suited for small to mid-sized life sciences companies that need to manage quality systems without a large internal compliance team, offering an intuitive, user-friendly interface with automated workflows throughout.

Core Modules and Capabilities

• Regulatory Intelligence (RI) Management: Qualcy RIM provides an AI-powered interface for monitoring global regulatory landscapes. Advanced machine learning algorithms track regulatory changes and deliver actionable insights, enabling pharmaceutical and biotech companies to stay ahead of regulatory updates and take proactive compliance actions.
• Risk Management: Supports risk management processes compliant with ISO 14971:2019 and requirements from multiple regulatory bodies including FDA, EU MDR, and Health Canada.
• Design Control Management: Provides a structured interface for managing the design control process for medical device applications, ensuring compliance with applicable regulations.
• Calibration Management: Enables management of calibration schedules and reports, with notifications and monitoring for past-due calibrations. Users can create and assign work orders, track their status, and retain calibration and maintenance records.
• Document Control: Ensures only current documents are available to users. Supports review and approval workflows for document changes, efficient search and access, and compliance with ISO standards and FDA regulations including 21 CFR Part 820 for medical devices.
• Audit Management: Simplifies audit planning and execution with automated tracking and follow-up for audit plans. Audit reports and non-conformances are released automatically upon report approval, and the system provides reminders for reviewers and task owners.
• Training Records: Supports assignment of training on an as-needed basis or automatically through the change control system. Tracks training completion, documents training records, ensures compliance with regulations and standards, and sends reminders for overdue training items.

Platform Design and Pricing

• Simple, user-friendly interface designed for ease of use with minimal training required.
• Modular architecture — customers can purchase only the modules they need and pay for additional training and support as required.
• Simple three-tiered pricing options with no annual maintenance fees and no hardware to purchase.
• Unlimited access with data secured and backed up on the Amazon AWS platform.
• Customized solutions available to address each customer's unique compliance needs.

Training and Support

• Qualcy provides both online and offline training for customers, including those with limited prior knowledge of regulatory standards.
• Implementation support is available and described by customers as timely and thorough.
• The support team is noted for being responsive, knowledgeable, and willing to tailor assistance to individual customer needs.

Qualcy eQMS is deployed as a cloud-based solution hosted on Amazon AWS, requiring no on-premise hardware. The platform is validated for GxP requirements and supports regulatory compliance for pharmaceutical, biotech, and medical device organizations. Customers have reported reductions in customer complaints and audit findings of over 60% within one year of adoption.