Qualityze

QUALITY MANAGEMENT FOR REGULATED INDUSTRIES

Quality Management Software for Nutraceuticals Industry

Consumers trust what’s on the label. Your quality system has to prove what’s behind it. Connect supplier quality, batch records, deviations, CAPA, risks, and approvals on Salesforce to keep nutraceutical quality consistent, traceable, and ready for audits.

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

Nutraceuticals Quality Challenges, Solved

Qualityze helps nutraceutical companies address quality, compliance, and operational challenges by connecting people, processes, and quality data.

The challenge

Verifying that incoming dietary ingredients meet established specifications for identity, purity, strength, and composition. With specialty ingredients coming from multiple sources, variability or incorrect materials can create quality problems before production even begins.

How Qualityze solves it

Qualityze QMS for Nutraceuticals helps teams manage incoming material inspections, supplier records, nonconformances, and CAPA within one closed-loop system. This provides traceable evidence of ingredient-quality decisions and investigation where materials fail inspections.

SYSTEM CAPABILITIES

How Qualityze Strengthen Nutraceutical Quality?

Qualityze QMS Software for nutraceutical helps team tighten quality controls across suppliers, incoming raw materials, specifications, ingredient approval, and batch release to ensure safer supplements.

Connected, Closed-Loop Platform

Bring ingredients approvals, labeling documentation, nutraceutical testing results, and more in one closed-loop quality environment.

IdentifyTriageAssessInvestigateActVerifyLearn

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

Connected nutraceutical quality and supplier operations
Connected nutraceutical quality and supplier operations

Nutraceutical Quality Management System

Manage quality events, nonconformances, batch failure, CAPAs affecting nutraceutical quality and patient safety.

Connected nutraceutical quality and supplier operations

Product Data Management System

Maintain all the nutraceutical formulation, ingredients, packaging, testing, and labeling data in one secure, validated platform.

Connected nutraceutical quality and supplier operations

Asset Management System

Keep a log of calibration and maintenance status of the equipment used for producing and testing nutraceuticals.

Connected nutraceutical quality and supplier operations

Environmental, Health and Safety System

Manage workplace safety events, environmental and temperature conditions, and nutraceutical handling to ensure product quality and worker safety.

Supplier Relationship Management System

Establish stronger quality controls over ingredient, excipient, packaging, and contract manufacturing suppliers.

QualifyApproveReceiveMonitorChangeCorrect
Connected nutraceutical quality and supplier operations

Post-Market Surveillance Management System

Manage product quality complaints, adverse events information, recall and other risks that may arise after nutraceutical distribution.

CaptureAssessInvestigateActTrendImprove
Connected nutraceutical quality and supplier operations

Built-In Continuous Improvement Tools

Use built-in, structured root cause analysis tools like 5Whys, Six Sigma, FMEA and effectiveness reviews to tighten quality controls.

DetectAnalyzePrioritizeCorrectVerifyStandardize
Connected nutraceutical 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 Nutraceutical QMS Software replaces common compliance bottlenecks with connected, traceable workflows.

Manual and disconnected Nutraceutical quality operations

Manual · Disconnected · Reactive

Supplier, ingredient, batch quality records are spread across disconnected systems
Different people follow different processes to handle quality events
Specification, SOP, and formulation changes take time to reach the right teams
Manual approvals take time that delays investigation and product release
Leadership lacks real-time visibility into quality data for effective management reviews
Controlled and proactive Nutraceutical quality operations

Validated · Connected · Inspection-Ready

One centralized, Salesforce-native platform for all your nutraceutical quality records
Structured closed-loop workflows to manage entire event lifecycle
Automated notifications are sent to involved team members to ensure timely actions
Support 21 CFR Part 11 with eSignature validation for every approval and guided workflows
Enterprise dashboards provide real-time visibility into quality KPIs, open actions, trends, and risk controls

FDA · cGMP · LABELING · SUPPLIER CONTROLS

FDA · cGMP · LABELING · SUPPLIER CONTROLS

FDA · cGMP · LABELING · SUPPLIER CONTROLS

  • 21 CFR Part 111 · Dietary Supplement cGMP

    Supports industry proven best practices for component acceptance, specifications, manufacturing, packaging, labeling, and more.

  • DSHEA · Dietary Supplement Oversight

    Helps maintain the quality and compliance records needed to manage dietary supplements and ingredients within the U.S.

  • 21 CFR Part 101 · Supplement Labeling

    Helps align with dietary supplement labeling requirements to avoid any compliance risks.

  • FSMA · Foreign Supplier Verification Program (FSVP)

    Provides guidance to maintain supplier quality and oversight for imported dietary supplements and ingredients.

  • 21 CFR Part 11 · Electronic Records & Signatures

    Provides a foundation for controlled electronic quality records, user access, audit trails, and electronic signatures.

FOOD SAFETY & SUPPLEMENT QUALITY STANDARDS

ISO · HACCP · NSF

  • ISO 22000 · Food Safety Management Systems

    Provides guidance on managing food-safety hazards, operational controls, documentation, and corrective actions.

  • Codex HACCP · Hazard Control

    Supports documentation for hazard assessment, preventive controls, monitoring, corrective action, and verification activities.

  • NSF/ANSI 455-2 · Dietary Supplement GMP

    Guidance for managing the quality processes, records, CAPA, and supplier controls used to support dietary supplement GMP programs.

  • NSF/ANSI 173 · Dietary Supplement Quality

    Guides through maintaining nutraceutical quality documentation around dietary-supplement certification programs.

GLOBAL NUTRACEUTICAL & FOOD COMPLIANCE

EU · FOOD SUPPLEMENTS · TRACEABILITY · HYGIENE

  • EU Directive 2002/46/EC · Food Supplements

    Supports quality and compliance documentation controls for dietary and food supplement marketed in European regions.

  • Regulation (EC) No 178/2002 · General Food Law

    Focuses on the traceability of supplier, ingredient, product, distribution, and quality records across the food supply chain.

  • Regulation (EC) No 852/2004 · Food Hygiene

    Guidance for having documented controls for maintaining hygiene, hazard evaluation and mitigation, and verification.

PROOF & RESOURCES

Proven Results. Connected Quality

See how Qualityze QMS for nutraceuticals helps 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

Nutraceuticals 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

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