by nuna.digital

Qualcy

Offers AI-enhanced regulatory compliance solutions for biotech and pharma, focusing on document control and FDA compliance with user-friendly software.

Overview

Qualcy specializes in providing comprehensive regulatory compliance solutions for biotech and pharmaceutical companies. Their platform is enhanced with AI-powered regulatory change monitoring, offering a unified solution for document control and FDA compliance. The products are designed to meet ISO Standards and 21 CFR Compliance, ensuring that all offerings are 21 CFR Part 11 Compliant.

Qualcy is committed to delivering customized solutions to meet the unique needs of each customer, aiming for 100% customer satisfaction. Their software is user-friendly, featuring simple and easy-to-use interfaces that facilitate transactions.

Unlimited Access
Simple 3 Tiered Pricing Options
No annual maintenance fees
No hardware purchase required
Secured and backed up on Amazon AWS platform

Qualcy provides both online and offline training to support customers who may not have a strong knowledge base regarding standards and regulations. Advanced machine learning algorithms are employed to monitor global regulatory landscapes, delivering actionable insights for pharmaceutical compliance teams.

Tools

Calibration Management Software System

Comprehensive solution for managing asset quality, including calibration, maintenance, and qualification, with features for tracking, notifications, and compliance.

A comprehensive solution for managing corrective and preventative actions (CAPA) processes, ensuring compliance with standards like ISO9000 and 21CFR part 820.

Comprehensive asset and calibration management solution for quality management of assets, including maintenance, calibration, and work order tracking.

Design Control Management

A platform for managing design control processes in medical device applications, covering planning, documentation, reviews, verification, validation, change management, and risk management.

A platform for managing design control processes in medical device applications, covering planning, documentation, reviews, verification, validation, change management, and risk management.

A system for managing risk processes in compliance with ISO14971:2019 and other regulations, including risk analysis, evaluation, and control documentation.

QMS Audit Management System

A comprehensive solution for managing internal, supplier, and third-party audits with features for planning, execution, tracking, and reporting.

QMS CAPA Software Solution

Comprehensive solution for managing CAPA processes with user-friendly interface, error-proof mechanisms, and secure role-based access.

QMS Document Management System

A system for managing, controlling, and accessing documents efficiently, ensuring compliance with ISO and FDA standards.

QMS NC Management

A comprehensive solution for managing process and product non-conformances with features like role-based access, workflow inbox, and customizable reporting.

QMS Training Management Software

A comprehensive system for managing training assignments, documentation, compliance, and reporting with automated reminders and secure access.

Regulatory Intelligence Management

AI-driven system for managing regulatory intelligence in pharma and biotech, aiding compliance and strategic decision-making.

Risk Management

A system for managing risk processes in compliance with ISO14971:2019 and other regulations, covering risk analysis, evaluation, control, and reporting.

Supplier Quality Management

End-to-end solution for managing supplier quality, including qualification, approval, and ongoing assessments with integrated audit capabilities.

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