Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Pharmaceutical Industry

Deliver high-quality medicines with greater control, consistency, and confidence. Qualityze Pharmaceutical Quality Management Software streamlines quality workflows, strengthens traceability, and helps pharmaceutical teams maintain ongoing regulatory and GxP compliance.

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

Trusted by quality teams across regulated industries

Read their success stories

INDUSTRY-SPECIFIC CHALLENGES

Pharmaceutical Quality Challenges, Solved

Qualityze Pharma QMS Software helps pharmaceutical manufacturers address quality, compliance, and operational challenges by connecting people, processes, and quality data.

The challenge

Maintaining compliance with evolving FDA, EMA, ICH, GxP, and electronic-record requirements. Disconnected, outdated systems and controls can increase documentation gaps, inspection findings, and regulatory risk.

How Qualityze solves it

Qualityze helps configure workflows and role-based controls to maintain data integrity, demonstrate compliance, and keep quality evidence organized and inspection-ready within a digital Pharmaceutical QMS.

SYSTEM CAPABILITIES

How Qualityze Ensure Pharma Compliance

Qualityze QMS Software helps pharmaceutical manufacturers maintain control from incoming materials and GMP manufacturing through testing, batch disposition, release, and post-market quality.

Connected, Closed-Loop Pharmaceutical Platform

Keep the records and decisions that determine pharmaceutical product quality, from approved materials to batch release, connected in a closed-loop system

QualifyManufactureTestReviewReleaseMonitorImprove

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

Connected Pharmaceutical quality
Connected Pharmaceutical quality

Pharma Quality Management System

Link quality events to affected batches, raw materials, inspection procedures, and suppliers for controlled GMP execution.

Connected Pharmaceutical quality

Product Data Management System

Connect supplier and material data with internal specifications, risks, batches, validations, and quality events so teams can assess the impact of data changes.

Connected Pharmaceutical quality

Asset Management System

Connect the event with affected batches, lab results, deviations, investigations, and CAPA to determine quality impact and restore the validated state.

Connected Pharmaceutical quality

Environmental, Health and Safety System

Connect EHS events with affected assets, areas, investigations, CAPA, and training to address operational risk before it affects people or production.

Supplier Relationship Management System

Connect supplier, CMO, CDMOs and material issues with specifications, incoming materials, deviations, and CAPA to determine impact and maintain ASL.

QualifyApproveReceiveMonitorChangeCorrect
Connected Pharmaceutical quality

Post-Market Surveillance Management System

Identify recurring events, assess their impact, and feed findings back into core manufacturing processes to deliver safe and effective medicines to customers.

CaptureAssessInvestigateActTrendImprove
Connected Pharmaceutical quality

Built-In Continuous Improvement Tools

Use RCA tools like 5Whys, FMEA , risk assessment, effectiveness checks, and connected quality data to reduce recurrence of quality events.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected Pharmaceutical quality

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 Pharmaceutical Quality Management Software replaces common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected Pharmaceutical quality operations

MANUAL · DISCONNECTED · REACTIVE

Outdated SOPs remain in GMP operations
Deviations sit apart from affected batches
OOS investigations move through disconnected records
Changes happen without full impact assessment
Calibration lapses put GMP equipment at risk
Supplier changes arrive without quality review
Audit evidence requires last-minute record hunts
Supplier issues remain separate from material quality
Batch records require manual QA reconciliation
Product quality trends require manual consolidation
Controlled and proactive Pharmaceutical quality operations

CONTROLLED · CONNECTED · PROACTIVE

Only approved SOPs reach trained personnel
Deviations link to batches, materials, and CAPA
OOS investigations follow one controlled workflow
Changes link to risk, validation, and training
Calibration status stays visible before equipment use
Supplier changes trigger documented impact assessment
Inspection evidence stays organized and ready
Supplier issues link to materials and batches
Batch quality records stay connected for review
Connected data supports Product Quality Reviews

Regulatory Frameworks Qualityze Supports

US · FDA

FDA · PHARMACEUTICAL CGMP

  • 21 CFR Parts 210 & 211 · Drug CGMP

    Support controlled processes for procedures, materials, manufacturing, and lab controls.

  • 21 CFR Part 11 · Electronic Records and Signatures

    Support electronic records, electronic signatures, access controls, audit trails, record retention, and system validation.

  • FDA Data Integrity · Drug CGMP

    Maintain controlled quality records with appropriate access, review, approvals, and audit history of cGMP data.

  • FDA Process Validation

    Connect validation activities with process changes, deviations, risk assessments, and CAPA with evidence.

  • 21 CFR Parts 600–680 · Biological Products

    Support Part 600 manufacturing quality processes for biologic operations where applicable.

EUROPEAN UNION

EU · GOOD MANUFACTURING PRACTICE

  • EudraLex Volume 4 · EU GMP

    Support core quality-system expectations for medicinal products for production, QC and inspection.

  • EU GMP Annex 1 · Sterile Medicinal Products

    Connect contamination-control actions with risk assessments and other quality processes for sterile medicinal-product manufacturing.

  • EU GMP Annex 11 · Computerized Systems

    Support validated computerized processes with controlled access, electronic records, and documented system oversight.

  • EU GMP Annex 15 · Qualification and Validation

    Connect qualification and validation records with equipment, processes, and changes in a closed-loop system.

  • EU GMP Annex 16 · QP Certification and Batch Release

    Keep batch deviations, investigations, changes, training and quality records connected to support controlled review and release.

  • EU Good Distribution Practice · GDP

    Support controlled distribution-quality records, supplier oversight, deviations, complaints.

INTERNATIONAL

ICH · PIC/S · GLOBAL GMP

  • ICH Q7 · GMP for Active Pharmaceutical Ingredients

    Manage API quality through controlled materials, suppliers, and manufacturing processes.

  • ICH Q9(R1) · Quality Risk Management

    Apply risk-based methods across deviations, CAPA, change control, suppliers, audits, assets, and manufacturing.

  • ICH Q10 · Pharmaceutical Quality System

    Connect process performance, product quality, CAPA, change management, management review, knowledge, and CI process.

  • ICH Q12 · Pharmaceutical Product Lifecycle Management

    Maintain controlled evaluation and traceability of post-approval changes across the pharmaceutical product lifecycle.

  • PIC/S GMP Guide · PE 009

    Standardize GMP quality processes, documentation, investigations, CAPA, training, supplier controls.

  • GAMP 5 · Computerized System Validation

    Apply a risk-based lifecycle approach to computerized system validation, intended use, testing, change control, and maintained validated state.

PROOF & RESOURCES

Proven Results. Connected Quality

See how regulated enterprises use Qualityze Pharma 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

Pharmaceuticals 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