Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Life Sciences Industry

Qualityze helps lifesciences organizations standardize quality processes across pharmaceutical, biotech, medical-device, and laboratory operations.

  • 21 CFR Part 11/EU GMP Annex 11 Ready
  • Risk Based Validation
  • Salesforce-Native Architecture
  • Salesforce
Quality Management Software for Life Sciences 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

Life Sciences Challenges, Solved

Qualityze QMS Software for life sciences helps organizations resolve quality, safety, and compliance challenges by connecting people, processes, and data.

The challenge

Disconnected paper and digital records make it difficult to preserve complete, consistent, accurate data or retrieve reliable evidence across laboratories, manufacturing, and quality operations.

How Qualityze solves it

Qualityze Enterprise QMS for Life Sciences provides a secure, centralized database to store all controlled documents and quality records with version control, eSignature validation, audit trails, role-based access, and traceability.

SYSTEM CAPABILITIES

How Qualityze Empowers Connected Life Sciences Operations

Unify quality, safety, product data, assets, suppliers, and improvement initiatives within one controlled, traceable platform.

Connected, Closed-Loop Platform

Configure closed-loop workflows to connect regulated processes, records, risks, assets, and teams in one place, ensuring enterprise-wide visibility.

DesignDevelopQualifyOperateMonitorImprove

The system maintains record traceability for informed decisions.

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

Life Sciences Quality Management System

Control documents, deviations, CAPA, changes, audits, complaints, risks, and training across the complete life sciences quality lifecycle.

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

Environment, Health and Safety System

Manage incidents, hazards, chemicals, environmental and safety obligations, training, and risks in life sciences establishments through connected EHS workflows.

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

Product Data Management System

Control specifications, formulations, design records, labeling, configurations, and product changes from development through commercialization.

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

Asset Management System

Track equipment qualification, calibration, maintenance, cleaning, work orders, and complete asset histories across life sciences facilities.

Supplier Relationship Management System

Qualify suppliers, monitor performance, conduct audits, manage supplier changes, and connect agreements, scorecards, SCARs, and CAPAs.

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

Post-Market Surveillance Management

Trace complaints, adverse events, safety signals, and field issues back to products, batches or lots, suppliers, manufacturing processes, and related quality events.

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

Built-In Continuous Improvement Tools

Transform quality and operational data into measurable improvements through trend analysis, root-cause investigation, structured projects, actions, and effectiveness checks.

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

7

Connected systems across quality, safety, product, asset, supplier, post-market, and improvement management

1

Shared data model across connected records and workflows

100%

Traceability across 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 Cloud-Based QMS for Lifesciences replace common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected life sciences quality operations without Qualityze

MANUAL · DELAYED · DISCONNECTED

Outdated SOPs remain in circulation
CAPA actions lose clear ownership
Training trails document revisions
Calibration records hide in binders
Complaint trends surface too late
Supplier changes arrive too late
Deviations wait for manual routing
Approvals depend on repeated follow-ups
Audit evidence requires frantic searching
Effectiveness checks are easily missed
Controlled and proactive life sciences quality operations with Qualityze

CONTROLLED · VISIBLE · PROACTIVE

Current procedures reach every user
Owners, deadlines, and escalations stay visible
Retraining starts when content changes
Asset status stays inspection-ready
Emerging signals trigger early action
Changes are assessed before product impact
Investigations begin with assigned owners
Workflows route approvals automatically
Records remain continuously inspection-ready
Verification completes every CAPA cycle

Regulatory Frameworks Qualityze Supports

UNITED STATES

US · FDA

  • 21 CFR Part 11

    Electronic records, electronic signatures, access security, and audit trails.

  • 21 CFR Parts 210 and 211

    Controlled documentation for procedures, production records, investigations, and quality-unit oversight.

  • FDA QMSR · 21 CFR Part 820

    Align medical-device quality processes with ISO 13485:2016, Part 820, and QMSR.

  • FDA Data Integrity Guidance

    ALCOA and ALCOA+ principles for regulated records and workflows.

EUROPEAN UNION

EU · European Union

  • EU GMP Annex 11

    Computerized-system validation, data integrity, security, audit trails, and electronic signatures.

  • EU MDR 2017/745

    Risk controls, technical documentation, CAPA, complaints, and post-market surveillance for medical devices.

  • EU IVDR 2017/746

    Quality, performance, vigilance, risk, corrective action, and post-market processes.

  • EudraLex Volume 4

    Pharmaceutical quality systems, GMP documentation, outsourced activities, complaints, recalls, and self-inspection.

INTERNATIONAL

ISO · ICH · Global

  • ISO 13485:2016

    Quality management requirements for the medical-device lifecycle and supply chain.

  • ISO 14971:2019

    Lifecycle identification, evaluation, control, and monitoring of risks associated with medical devices.

  • ICH Q10

    Pharmaceutical quality including development, technology transfer, commercial manufacturing, and product discontinuation.

  • GAMP 5 · Second Edition

    Risk-based lifecycle guidance for GxP computerized systems that are compliant and fit for intended use.

PROOF & RESOURCES

Proven Results. Connected Quality

See how regulated enterprises use Qualityze AI-Powered QMS for Lifesciences 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

Life Sciences 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

Explore how Qualityze connects quality, safety, product, asset, supplier, and improvement processes within one controlled and traceable platform.

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