QMS Software

QMS Software is an AI-powered solution designed to ensure seamless regulatory compliance within the pharmaceutical industry. It facilitates faster resolution of deviations by standardizing investigations and automating validation processes, ensuring that companies remain audit-ready at all times.

AI Investigator

The software leverages AI to standardize investigations through AI-driven root cause analysis (RCA), enabling the generation of science-backed Corrective and Preventive Actions (CAPAs). This approach helps reduce the recurrence of issues, thereby protecting product quality and lowering risks.

FDA Tracker

QMS Software provides proactive FDA readiness by analyzing FDA 483 trends, monitoring warning letters, and understanding investigator patterns. Users can download free audit checklists to ensure they are always prepared for inspections.

Cleaning Validation

The system automates cleaning validation by performing HBEL-based residue calculations, tracking residue data in real-time, and auto-generating validation reports to ensure 100% FDA compliance.

Key Features

• Consistent Investigations: AI ensures every investigation follows a standardized, science-based approach for reliable outcomes.
• Audit Readiness: Automated reports, digital records, and proactive monitoring ensure every site is inspection-ready.
• Effortless Validation: Automates residue calculations, risk assessments, and compliant reports for speed and accuracy.

The software accelerates investigations by streamlining data collection and enabling intelligent querying, allowing users to quickly identify root causes and resolve issues efficiently. This ensures compliance and operational excellence across pharmaceutical manufacturing sites.

Currently, over 300 pharmaceutical facilities worldwide, including sites in Canada, Mexico, the USA, China, and India, utilize this software to maintain compliance and enhance manufacturing processes.