Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Healthcare Industry

Qualityze Healthcare QMS bring every quality process into one connected system. Teams can manage quality records, compliance workflows, approvals, risks, and teams so organizations can standardize execution without creating another operational silo.

  • 21 CFR Part 11/EU GMP Annex 11 Ready
  • Risk Based Validation
  • Salesforce-Native Architecture
  • Salesforce
QMS for Healthcare Industry
  • LifeMD
  • Highridge
  • The Andersons
  • Prayon
  • Grynova Consulting Group
  • Cavin Care

Trusted by quality teams across regulated industries

Read their success stories

INDUSTRY-SPECIFIC CHALLENGES

Healthcare Quality Challenges, Solved

Qualityze QMS for Healthcare helps teams address quality, compliance, and operational challenges by connecting people, processes, and quality data.

The challenge

Reporting medication errors, healthcare-associated infections, patient identification failures, pressure injuries, and other safety events with consistency and accuracy. This further impacts investigation and resolution timelines.

How Qualityze solves it

Qualityze provides teams a closed-loop system to track entire incident lifecycle right from intake to root cause analysis (RCA), corrective actions, and effectiveness review. Our AI-Powered Healthcare Quality Management System automatically routes higher-risk events to the appropriate teams, ensuring timely action.

SYSTEM CAPABILITIES

How Qualityze Ensure Quality Care?

Qualityze connects quality across the healthcare enterprise to standardize execution, strengthen GMP compliance, and maintain product quality, safety, and effectiveness.

Connected, Closed-Loop Platform

Bring policies, incidents, complaints, risks, investigations, audits, training, and patient safety even in one closed-loop quality environment.

IdentifyTriageAssessInvestigateActVerifyLearn

The system maintains end-to-end traceability for informed decisions.

Connected Healthcare quality and supplier operations
Connected Healthcare quality and supplier operations

Healthcare Quality Management System

Link patient safety events, near misses, adverse events, investigations, CAPA, and follow up activities to ensure safety and reduce recurrences.

Connected Healthcare quality and supplier operations

Product Data Management System

Connect healthcare product data, specifications, regulatory data, validation data, and change data to assess impact before implementing any change.

Connected Healthcare quality and supplier operations

Asset Management System

Get visibility into med device calibration, qualification, service records, and maintenance status for safer healthcare operations.

Connected Healthcare quality and supplier operations

Environmental, Health and Safety System

Connect workplace incidents, permits, controlled environment exposure, and risk controls to proactively manage work-related risks.

Supplier Relationship Management System

Connect supplier qualifications, quality agreements, performance, SCARs to maintain complete oversight of critical suppliers.

QualifyApproveReceiveMonitorChangeCorrect
Connected Healthcare quality and supplier operations

Post-Market Surveillance Management System

Keep complaints, adverse events, regulatory reporting connected to manage risks and ensure product safety.

CaptureAssessInvestigateActTrendImprove
Connected Healthcare quality and supplier operations

Built-In Continuous Improvement Tools

Use 5 Whys, risk assessment, RCA, effectiveness checks, and connected quality records to reduce recurrence and ensure reliable outcomes.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected Healthcare quality and supplier operations

7

Quality, safety, product, asset, supplier, post-market vigilance and improvement management

1

Consistent information across connected records and workflows

100%

Linked actions, approvals, changes, and supporting evidence

Enterprise Visibility

Cross-site insights across teams, processes, and operations

THE SHIFT

From Reactive Quality to Proactive Control

See how Qualityze Healthcare Quality Management System replaces common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected healthcare quality operations

MANUAL · DISCONNECTED · REACTIVE

Clinical quality, safety, compliance records live in silos
Patient safety events, deviations, and complaints are handled through different processes
Policy updates take time to reach to right employees
Manual signatures delay regulatory submissions and approvals
Leadership lacks visibility on processes and risks
Controlled and proactive healthcare quality operations

VALIDATED · CONNECTED · INSPECTION-READY

One centralized sales-force native platform for all the records.
tructured workflows to manage entire process cycle
Document changes trigger notifications and training programs respectively
Compliant e-signatures accelerate approval workflows and demonstrate compliance with 21 CFR 11
Enterprise KPI dashboard gives real time visibility into ongoing processes and risk controls

Regulatory Frameworks Qualityze Supports

US · FDA

ISO · MEDICAL DEVICE & CLINICAL QUALITY

  • ISO 13485 · Medical Device QMS

    Establishes QMS requirements for medical device design, development, and production in a controlled environment.

  • ISO 14971 · Medical Device Risk Management

    Provides a framework to identify, control, and monitor risk controls that ensure effectiveness of medical devices.

  • ISO 15189 · Medical Laboratory Quality

    Outlines the requirements for quality and competence management for medical labs with documentation.

  • ISO 19011 · Management System Auditing

    Provides structured guidance to plan, conduct, and monitor quality management-system audits.

  • ISO 10012 · Measurement Management Systems

    Defines a standard measurement process for controlled calibration and maintenance activities that ensure reliable finished products.

U.S. HEALTHCARE & LIFE SCIENCES

FDA · QMSR · GxP · ELECTRONIC RECORDS

  • FDA QMSR · 21 CFR Part 820

    Establishes FDA QMS requirements for medical devices and incorporates ISO 13485:2016 into the revised QMSR.

  • 21 CFR Part 11 · Electronic Records & Signatures

    Supports controlled electronic records, electronic signatures, system access, audit trails, and data integrity.

  • 21 CFR Parts 210 & 211 · Pharmaceutical cGMP

    Supports controlled pharmaceutical manufacturing and quality processes including records and lab controls.

  • 21 CFR Part 803 · Medical Device Reporting

    Supports controlled processes to capture, assess, document, and report qualifying device-related adverse events and product problems.

  • HIPAA · Privacy & Security Rules

    Supports governance of protected health information and electronic PHI through appropriate controls.

GLOBAL LIFE SCIENCES COMPLIANCE

EU · MDR · IVDR · ICH · GMP

  • EU MDR 2017/745 · Medical Devices

    Framework to establish quality, risk, traceability, vigilance, and post-market processes for medical devices selling in the EU market.

  • EU IVDR 2017/746 · In Vitro Diagnostics

    Guidance for industry best practices to produce and sell in vitro diagnostic medical devices.

  • ICH Q9(R1) · Quality Risk Management

    Provides a systematic framework to assess, control, and manage pharmaceutical quality risks.

  • ICH Q10 · Pharmaceutical Quality System

    Provides a lifecycle-based pharmaceutical quality framework connecting core quality systems and continual improvement.

  • EU GMP Annex 11 · Computerized Systems

    Establishes expectations for computerized systems used in GMP-regulated activities.

PROOF & RESOURCES

Proven Results. Connected Quality

See how enterprises use Qualityze Integrated Healthcare QMS Software to strengthen quality, safety, and compliance controls in one closed-loop system.

Data-Driven, Defensible Decisions

AI-powered insights grounded in your own data help make defensible decisions, faster.

Closed-Loop Quality Execution

One closed-loop system to manage reviews, approvals, investigations, and follow-up actions.

Giant Pharmaceutical Manufacturer logo

Giant Pharmaceutical Manufacturer

Life Sciences

Lower operational costs

Challenge

Manual investigations and email-based approvals delayed deviation closure across multiple manufacturing sites.

Result

Connected workflows improved ownership, accelerated reviews, and linked deviations directly with investigations, CAPA, and effectiveness checks.

Download the Case Study
Medical Device Manufacturer logo

Medical Device Manufacturer

ISO 13485 · FDA

Faster audit preparation

Challenge

Scattered documents and quality records made ISO 13485 and FDA inspection preparation time-consuming.

Result

Centralized records, controlled workflows, and traceable audit evidence helped teams maintain continuous inspection readiness.

Download the Case Study
Growing Biotechnology Company logo

Growing Biotechnology Company

Scaling operations

Lower quality process costs

Challenge

Rapid growth increased quality workloads, while manual processes struggled to scale across teams and programs.

Result

Configurable workflows standardized execution, improved visibility, and supported expansion without adding equivalent administrative overhead.

Download the Case Study

CUSTOMER SUCCESS STORIES

Healthcare Leaders Trust Qualityze

From clinical-stage biotech to global pharma and medical device manufacturers, quality teams use Qualityze to cut review cycles, close findings faster, and stay continuously inspection-ready.

FROM THE BLOG

Insights on
Modern Quality

Explore practical perspectives on connected quality, compliance, risk, and continuous improvement.

See Qualityze in Action

See how Qualityze connects operational processes and quality data to support better decisions and measurable improvement.

Qualityze
info@qualityze.com+1-877-207-8616

USA Corporate Headquarters

Qualityze Inc.3903 Northdale Blvd Suite: 100ETampa, FL 33624, USA

UK Regional Office

Qualityze Inc.450 Bath Rd, Longford, Heathrow,West Drayton UB7 0EB, United Kingdom

India Regional Office

Qualityze Solutions Pvt Ltd.No. 27, 1st floor, 80 Feet Ring Rd, 2nd Stage,KHB Colony, Basaveshwar Nagar, Bengaluru,Karnataka 560079, INDIAPhone: +91 96117 58187

2015 – 2026 Qualityze Inc