Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Manufacturing Industry

Keep quality and manufacturing onto the same page and pace with Enterprise Manufacturing QMS. Bring documents, quality events, approvals, and teams together to standardize operations, act faster, and maintain excellence in delivered quality. Zero silos take teams closer to zero-defect manufacturing.

  • 21 CFR Part 11/EU GMP Annex 11 Ready
  • Risk Based Validation
  • Salesforce-Native Architecture
  • Salesforce
QMS Software for Manufacturing 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

Manufacturing Quality Challenges, Solved

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

The challenge

Managing evolving ISO, industry, customer, and applicable regulatory requirements while maintaining controlled quality records. Disconnected systems, processes, and outdated documentation increase audit findings and compliance risk.

How Qualityze solves it

Qualityze helps configure cGMP-aligned workflows, approvals, role-based access, and quality records so manufacturers can maintain data integrity, compliance, and quality evidence organized in an audit-ready format within a digital Manufacturing QMS.

SYSTEM CAPABILITIES

How Qualityze Ensure Total Quality Control?

Qualityze connects quality across the manufacturing lifecycle, from suppliers and incoming inspection to production, issue resolution, change management, and finished-product quality.

Connected, Closed-Loop Platform

Keep a log of all the records, processes, and decisions that determine finished product quality, from supplier quality to final release, connected in a closed-loop system.

QualifyManufactureTestReviewReleaseMonitorImprove

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

Connected life sciences quality, safety, product, asset, and supplier operations
Connected life sciences quality, safety, product, asset, and supplier operations

Manufacturing Quality Management System

Link defects and nonconformances to raw material inspections, suppliers, and audits for controlled quality.

Connected life sciences quality, safety, product, asset, and supplier operations

Product Data Management System

Link supplier data with regulatory requirements, validation controls, and internal specifications so teams can manage the impact of supplier changes effectively.

Connected life sciences quality, safety, product, asset, and supplier operations

Asset Management System

Maintain visibility of equipment calibration and maintenance status so teams can anticipate downtime and implement preventive controls in time.

Connected life sciences quality, safety, product, asset, and supplier operations

Environmental, Health and Safety System

Connect workplace safety controls, permit, safety training, and risk assessment so teams can contain or prevent safety risks before their impact spreads.

Supplier Relationship Management System

Connect supplier qualifications, incoming quality issues, audits, performance, risks and SCAR so teams can address supplier issues before they impact production.

QualifyApproveReceiveMonitorChangeCorrect
Connected life sciences quality, safety, product, asset, and supplier operations

Post-Market Surveillance Management System

Identify production failure and defect ratio trends to feed insights back into Manufacturing QMS to ensure consistent quality outcomes.

CaptureAssessInvestigateActTrendImprove
Connected life sciences quality, safety, product, asset, and supplier operations

Built-In Continuous Improvement Tools

Use 8D, 5 Whys, risk assessment, RCA, effectiveness checks, and connected quality records to reduce recurrence and make sustainable improvements.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected life sciences quality, safety, product, asset, 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 Quality Management Software for Manufacturing replaces common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected Manufacturing quality operations without Qualityze

SILOED · INCONSISTENT · REACTIVE

Sites manage same processes with different quality controls
Quality records live in silos
No clear accountability in nonconformances reports
Issues recur before previous CAPAs are fully understood
Supplier issues remain hidden in reviews and CAPA data
Inconsistent impact assessments are conducted before implementing change
Employees continue to work as per outdated procedures or training
Audit findings are tracked separately from corrective actions
Quality actions become overdue across sites without clear visibility
Enterprise quality trends require manual consolidation across locations
Controlled and proactive Manufacturing quality operations with Qualityze

CONNECTED · STANDARDIZED · PROACTIVE

Standardized workflows to maintain consistent quality controls and execution
Quality records stay connected in a closed-loop system
NCRs follow defined ownership, investigation, and closure process
CAPA history helps teams identify and prevent recurring issues
Supplier quality records stay connected from issue to resolution
Change controls connect risk, approvals, actions, and training
Approved documents and training stay aligned for every job function
Audit findings flow directly into accountable corrective actions
Centralized tracking highlights overdue actions and escalation needs
Cross-site quality data reveals recurring risks and performance gaps

Regulatory Frameworks Qualityze Supports

UNITED STATES

ISO · QUALITY MANAGEMENT

  • ISO 9001 · Quality Management Systems

    Outlines a framework for controlled quality management processes to deliver consistent quality outcomes.

  • ISO 19011 · Management System Auditing

    Provides a structured framework for planning, conducting, and managing audits and their follow-ups.

  • ISO 10012 · Measurement Management Systems

    Specifies a framework for measurement management systems including calibration and equipment measurement records.

  • ISO 10013 · QMS Documented Information

    Provides guidance for maintaining controlled documents like SOPs and their revisions.

  • ISO 10002 · Customer Complaint Management

    Guides organizations about designing and establishing a controlled complaints management system.

INDUSTRY-SPECIFIC MANUFACTURING

AUTOMOTIVE · AEROSPACE · INDUSTRIAL

  • IATF 16949 · Automotive Quality Management Systems

    Combines ISO 9001 requirements with strict automotive-specific rules to prevent defects and waste.

  • AS9100 · Aerospace Quality Management Systems

    Builds on ISO 9001 with strict rules for product safety, risk management, and traceability in the aerospace supply chain.

  • APQP · Advanced Product Quality Planning

    Provides a structured framework for cross-functional teams to design and build quality components and products.

  • PPAP · Production Part Approval Process

    Maintain controlled approval records, supporting quality documentation, changes, supplier inputs, and required review activities.

  • FMEA · Failure Mode and Effects Analysis

    Connect identified manufacturing risks with controls, corrective actions, process changes, inspections, and supporting quality records.

  • SPC · Statistical Process Control

    Support documented review of manufacturing quality trends, identified issues, investigations, and resulting corrective actions.

INTERNATIONAL

ISO · RISK · SUPPLIER · CONTINUAL IMPROVEMENT

  • ISO 31000 · Risk Management

    Apply a risk-based framework to manage uncertainty, protect assets, and improve decision-making.

  • ISO 10005 · Quality Plans

    Provides guidelines to create, review, accept, apply, and update quality plans.

  • ISO 10015 · Competence Management

    Provides a framework to align employee training and skills development with strategic quality goals.

  • ISO 10017 · Statistical Techniques for ISO 9001

    Support structured use of quality data and statistical methods to imprve the existing quality systems.

  • ISO 9004 · Quality of an Organization

    Focuses on organizational learning, stakeholder needs, and continual improvements.

  • Lean Manufacturing · Continuous Improvement

    Focuses on maximizing customer value while minimizing waste with small, ongoing changes.

PROOF & RESOURCES

Proven Results. Connected Quality

See how quality teams use Qualityze Digital Manufacturing QMS to strengthen quality, safety, and compliance controls in one connected ecosystem.

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

Manufacturing 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.

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