AI-Powered
Quality Management System
Close out deviations and CAPAs faster while simplifying your compliance needs. Our QMS provides a single source of truth for all your quality processes, from risk and audit management to change control and CAPAs.
One platform for Global Compliance
The intelligent, unified Quality Management System is designed to reduce compliance risks, support regulatory requirements (GxP, ISO, FDA 21 CFR Part 11) and enable data-driven decision-making.
Accelerate Quality Cycles
Ensure investigations are closed in days instead of weeks, and eliminate administrative bottlenecks that delay batch release. With our QMS software, you streamline workflows and reduce administrative burden.
Be Audit-Ready, Always
Embeds GxP and 21 CFR Part 11 compliance into every action, providing immutable, on-demand audit trails. Drastically reduce audit preparation time from weeks to hours and minimise the risk of regulatory observations
Gain Predictive Insights
Our AI-driven QMS unifies information from suppliers, complaints, and deviations to reveal hidden trends and predict risks, empowering you to prevent quality events before they occur.
A Comprehensive Suite of Features Delivered Through an Intuitive and Accessible Interface
Customizable Processes
Flexible Quality Workflows or Bespoke Process
Our flexible QMS workflows adapt to your unique needs, streamlining Non-Conformances, Quality Events, Investigations, CAPAs, Change Controls, and Audit Management, ensuring consistency and compliance. Configure process interlocks and ensure events are handled in a compliant way.
Easy Collaboration
Collaboration-First Approach for Visibility and Accountability
Our platform eliminates information silos with built-in conversations, making it your single source of truth. Drive accountability with clear task assignments and deadlines, ensuring everyone is on the same page.
21 CFR Part 11 Compliant Signatures
Audit Trails and E-Signatures for GxP Compliance
Our system provides a 21 CFR Part 11-compliant audit trail for every action. Secure e-signatures eliminate manual processes, accelerating cycle times and ensuring timely execution.
Smart Analytics
Rich Reporting and Custom Dashboards
Our powerful QMS reporting and analytics dashboards provide deep insights, helping you analyse frequent issues, overdue events, and uncover operational bottlenecks that were previously invisible.
Controlled Access
Fine-Grained Access Control Privileges
Our fine-grained access control privileges ensure that only authorised personnel can access sensitive information, maintaining data integrity and regulatory compliance.
When reviewing the platform, it's clear it was engineered with growth in mind. The unified solution is inherently more scalable than trying to bolt on different systems during a high-growth phase.
Jayanth Sridhar
CEO • Biologics, Dr. Reddy's
For brands that outsource manufacturing, this ability to extend GxP control and maintain a single source of truth with their CMOs is a significant leap forward in mitigating risk.
Varun Chandra
Vice President of R&D, Quality, and Regulatory • SeneGence
