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Next-Gen Quality Management. Built for Compliance. Powered by AI.
Built for Lifesciences and Manufacturing Operational Excellence
Trusted by Fortune 500 companies, Qualityze suite unifies quality, safety, suppliers, products, and asset management processes in one intelligent system to accelerate decision making, achieve enterprise objectives and global compliance.
Select a suite to explore the solution stack, capabilities, and connected workflows that power modern quality, safety, asset, product, post-market and supplier quality management processes.
All-in-one closed-loop system for enterprise quality management.
Built natively on Salesforce, Qualityze embeds agentic AI across every quality process so you can manage quality events before they become bigger and more expensive. Transform your reactive QMS into a proactive and predictive engine for operational excellence.
Inheriting enterprise-grade AI, security, and global scale directly from the world's #1 CRM platform.
Two-Way Interaction Engine. Click a solution stack to view its details — or select an NPI Phase to highlight every platform pillar supporting that stage.
Define design inputs, build the Design History File, and lock baseline specifications before anything moves to the floor.
This phase drives the primary business processes that connect Qualityze platform capabilities into a continuous closed-loop quality ecosystem.
Voice of the Customer
Join the league of innovation leaders in the world of quality, safety, and compliance with Qualityze
Qualityze offers AI-Powered quality management software solutions that are designed with industry best practices in mind, catering to the requirements defined by regulatory bodies such as the FDA, ISO, and industry-specific standards.
One configurable, connected QMS platform that scales across sectors, sites, and standards, adapting to the quality and compliance demands of every sector from life sciences to regulated manufacturing.

FDA 21 CFR Part 11

ISO 13485

GMP

ISO 9001

HIPAA-Aware

FSMA

AS9100

IATF 16949

ISO 14001

API Q1

FDA 21 CFR Part 11

ISO 13485

GMP

ISO 9001

HIPAA-Aware

FSMA

AS9100

IATF 16949

ISO 14001

API Q1
Stay aligned with industry-specific regulatory frameworks that define quality, safety, compliance, and operational excellence across life sciences and regulated manufacturing industries.
Qualityze helps enterprises support Part 11 expectations for managing secure electronic records, controlled workflows, audit trails, role-based access controls, and electronic signature validation.
Go beyond capturing details and reacting to quality events. Qualityze embeds industry-proven problem-solving frameworks across every quality process to drive lasting resolutions for every issue logged.
Guide cross-functional teams through a systematic 8-Disciplines methodology to investigate complex issues, identify root causes, and drive permanent corrective actions.
Map process, product, and system risks, evaluate severity, occurrence, and detection scores, and prioritize preventive controls to avoid bigger failures.
Asking the right questions helps you drill down to the true root causes and define structured remediation actions to prevent repetitive quality events.
Run the Plan, Do, Check, and Act cycle to test changes, measure outcomes, and standardize what works as repeatable best practices for continuous quality improvement.
Use a data-driven continuous improvement methodology—Define, Measure, Analyze, Improve, and Control—to reduce variation, eliminate defects, and sustain measurable process gains.
Evaluate Risk Priority Numbers by analyzing severity, likelihood, and impact to prioritize high-risk issues and focus resources where they matter most.
Leverage structured A3 problem-solving templates to define issues, identify root causes, implement corrective actions, track outcomes, and drive Kaizen-based continuous improvement.
Guide cross-functional teams through a systematic 8-Disciplines methodology to investigate complex issues, identify root causes, and drive permanent corrective actions.
Map process, product, and system risks, evaluate severity, occurrence, and detection scores, and prioritize preventive controls to avoid bigger failures.
Asking the right questions helps you drill down to the true root causes and define structured remediation actions to prevent repetitive quality events.
Run the Plan, Do, Check, and Act cycle to test changes, measure outcomes, and standardize what works as repeatable best practices for continuous quality improvement.
Use a data-driven continuous improvement methodology—Define, Measure, Analyze, Improve, and Control—to reduce variation, eliminate defects, and sustain measurable process gains.
Evaluate Risk Priority Numbers by analyzing severity, likelihood, and impact to prioritize high-risk issues and focus resources where they matter most.
Leverage structured A3 problem-solving templates to define issues, identify root causes, implement corrective actions, track outcomes, and drive Kaizen-based continuous improvement.
Answer 5 focused questions to understand your existing state of quality maturity.
Built on a Salesforce-native platform, Qualityze empowers quality leaders with the control, clarity, and visibility needed to improve quality performance across systems, sites, and suppliers.
Built for regulated, quality-critical enterprises