Catalyst Quality Management System
A New way of managing and controlling quality
Catalyst Quality Management Systems (QMS)
A breakthrough AI-based eQMS platform , Catalyst QMS is designed to redefine quality management for pharmaceutical, medical devices, and biotech industries . Built using the latest plug-and-play technology , it offers unmatched flexibility and adaptability, ensuring seamless integration into your existing systems.
Catalyst QMS is completely configurable to suit your organization's unique needs, making it easy to implement and adopt. By leveraging advanced features and automation, it enables significant improvements in operational efficiency, compliance, and audit readiness.
What Makes Catalyst QMS Different
Fully configurable to your quality workflows, effortless to use, and fast to implement - built on advanced, modern technology so your teams adopt it from day one.
Key Benefits of Catalyst QMS:
- • Achieve up to 60% savings in the cost of Quality by streamlining quality management processes.
- • Enhance compliance with regulatory standards , including FDA 21 CFR Part 11 .
- • Optimize workflows and simplify approvals to reduce delays and human errors.
- • Improve audit readiness and compliance tracking with real-time insights and analytics.
- • Seamlessly manage and control quality processes through an integrated platform.
Catalyst QMS offers a dramatic increase in efficiency and productivity, making it an essential tool for highly regulated industries like pharma and biotech. Whether you're managing CAPA, deviations, change control, or other quality processes, Catalyst QMS ensures your organization stays ahead in compliance and quality excellence.
Complies to EU Annex 11, 21CFR Part 11, SFDA, etc.
Automates & Standardize all quality processes
Validated System
Automated Trend Analysis
Helps in tracking, improving & preventing defects
Paperless QMS flow
Frequently Asked Questions (FAQ's)
What is a Quality Management System (QMS) for pharma?
A Quality Management System is a structured framework of processes, procedures and records that ensures products and operations consistently meet regulatory and quality standards. In pharma, a QMS covers deviation management, CAPA, change control, complaints, audits, supplier quality and document control — providing a single, auditable system of record across the quality function.
Is Catalyst QMS compliant with FDA 21 CFR Part 11 and EU GMP Annex 11?
Yes. Catalyst QMS is designed for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance, with role-based access control, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls built into every quality workflow.
How configurable is Catalyst QMS to our existing quality processes?
Catalyst QMS is completely configurable — forms, workflows, approval hierarchies, templates, numbering schemes, notifications and reports can all be tailored to match your SOPs and site-specific requirements. You don't have to re-engineer your quality processes to fit the software; the software adapts to you.
How long does it take to implement and validate Catalyst QMS?
Implementation is fast and low-effort thanks to the configurable, out-of-the-box design. Most sites go live in weeks rather than months, with full CSV (Computer System Validation) documentation, IQ/OQ/PQ protocols and 21 CFR Part 11 compliance support provided as part of the rollout.
Does Catalyst QMS handle deviation, CAPA and change control workflows?
Yes. Catalyst QMS provides end-to-end deviation, CAPA, change control, OOS/OOT, complaint, audit and supplier quality workflows with automatic escalation, electronic approvals, effectiveness checks and full traceability to batch, product and site.
Does Catalyst QMS integrate with ERP, LIMS and other quality systems?
Yes. Catalyst QMS integrates with ERP and MES for master and batch data, and connects natively with the rest of the Catalyst platform — LIMS, eBMR, eLogBook, Calibration & Maintenance, Training and APQR — giving you a single source of truth for quality and manufacturing data across the enterprise.
How does Catalyst QMS improve data integrity and audit readiness?
Every action is validated against configured business rules, changes are captured in an immutable audit trail, and approvals are electronically signed — eliminating paper records, missing signatures and illegible entries. This makes inspections faster and audit-ready documentation available at the click of a button.
Ready to Transform Your Quality Management?
See how Catalyst QMS replaces paper and spreadsheets with configurable, audit-ready workflows for deviations, CAPA, change control and more — keeping every quality record inspection-ready, end to end.
Schedule a Free Demo