Compliance-Ready EQMS for Nutraceuticals
Discover how our EQMS integrates AI-powered analytics, automated workflows, and real-time monitoring to simplify processes and maintain compliance with standards like FDA 21 CFR Part 117 and GMP. From managing multi-tier supply chains to validating clean labels and non-GMO certifications, our solution provides the tools you need to stay ahead in a competitive market. Experience the future of quality management, where safety, compliance, and innovation converge.
Meet Consumer Demands for Non-GMO, Allergen-free, And Organic Products Effortlessly
The modern-day consumers are more informed and discerning than ever, demanding products that align with their values and health priorities. So much so that meeting the growing demand for non-GMO, allergen-free, and organic nutraceuticals has become a competitive necessity. With our EQMS, you can effortlessly ensure product integrity, streamline certifications, and maintain transparent supply chains that inspire trust. Our next-generation solutions empower your brand to deliver safe, high-quality products that stand out in the market while staying compliant with stringent standards like USDA Organic, Non-GMO Project Verified, and allergen management protocols. Let us simplify the complexity, so you can focus on creating products your customers love.
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The Qualityze Difference Empowers You To:
Ensure Raw Material Quality, Consistency, and Supply Chain Transparency
Proactively manage raw material variability and ensure traceability across the supply chain. Our EQMS provides real-time supplier performance monitoring, risk assessments, and detailed traceability to maintain the consistency, quality, and safety of botanical and bioactive ingredients in compliance with standards like FDA cGMP and ISO 22000.
Streamline Complex Formulations and Stability Management
Simplify the management of complex nutraceutical formulations with configurable workflows for recipe creation, change management, validation, and stability testing. Our solution ensures accurate documentation, compliance with standards like ISO 9001 and 21 CFR Part 111, and product integrity throughout the shelf life.
Combat Adulteration, Contamination, and Cross-Contamination Risks
Leverage automated workflows and integrated quality checks to mitigate risks of adulteration, contamination, and cross-contamination. Our EQMS supports compliance with allergen management standards and ensures product safety, especially in shared manufacturing environments.
Manage Labeling, Health Claims, and Consumer Expectations
Avoid regulatory penalties and respond to consumer demands for clean labels, organic, non-GMO, and allergen-free products. Our centralized system facilitates evidence-backed claim management and compliance with regulations like FDA and Codex Alimentarius guidelines, while also supporting voluntary certifications like USDA Organic.
Enhance Testing, Efficacy Validation, and Certification Compliance
Standardize testing methods, validate product efficacy, and streamline compliance with multi-certification requirements. Our EQMS provides centralized management of testing protocols, clinical data, and certifications like GMP and NSF/ANSI 173, ensuring consistent quality and audit readiness.
Adapt to Evolving Regulatory Landscapes with Post-Market Surveillance
Stay ahead of changing regulations with pre-configured compliance workflows and integrated tools for post-market surveillance. Our EQMS supports adverse event tracking, root cause analysis, and proactive risk management to ensure safety, build consumer trust, and meet standards like ISO 22000 and FDA 21 CFR Part 117.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 9001 | General Quality Management System Requirements |
| ISO 22000 | Food Safety Management Systems |
| ISO/TS 22002-1 | Prerequisite Programs on Food Safety |
| ISO 31000 | Risk Management Principles and Guidelines |
| ISO 22716 | Good Manufacturing Practices (GMP) for Cosmetics (Applicable to Nutraceutical Supplements with Similar Processing Practices) |
| FDA Regulations | |
| 21 CFR Part 11 | Electronic Records and Signatures |
| 21 CFR Part 111 | Current Good Manufacturing Practice (cGMP) for Dietary Supplements |
| 21 CFR Part 117 | Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Applicable to Nutraceuticals Classified as Food) |
| 21 CFR Part 101 | Food Labeling Requirements |
| GxP Guidelines | |
| Good Manufacturing Practices (GMP) | Specific to Dietary Supplements and Nutraceuticals |
| Good Laboratory Practices (GLP) | For Testing and Validation Processes |
| EU Regulations | |
| Regulation (EC) No 178/2002 | General Principles and Requirements of Food Law |
| Regulation (EC) No 852/2004 | Hygiene of Foodstuffs |
| Regulation (EC) No 1924/2006 | Nutrition and Health Claims Made on Foods |
| ICH Guidelines | |
| ICH Q8 | Pharmaceutical Development (Relevant to Nutraceutical Formulations) |
| ICH Q9 | Quality Risk Management |
| ICH Q10 | Pharmaceutical Quality System |
| Pharmacovigilance Standards | |
| ICH E2E | Pharmacovigilance Planning (Applicable for Safety Monitoring of Nutraceutical Products with Health Claims) |
| WHO Guidelines | Monitoring Safety of Medicinal Products Derived from Natural Sources |
Reasons to choose Qualityze EQMS for Nutraceuticals Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Nutraceuticals industry because it has
User-Friendly Interface
Simplifies usability with an intuitive design, requiring no technical expertise.Seamless Integration
Fits perfectly with your existing systems to enhance operational efficiency.Cloud-Based Platform
Provides secure, flexible, and anywhere-accessible data management.Automated Upgrades
Keeps you up-to-date effortlessly with automatic version upgrades.Configurable workflows and Fields
Adapts to your unique business processes with configurable options.Low Implementation Costs
Delivers a cost-effective solution without compromising on performance.Minimal Maintenance Needs
Eliminates hardware dependencies, offering easy access from any location.Flexibility and Security
Combines robust security with cloud-based flexibility to meet dynamic needs.AI-Powered Assistant
Offers intelligent support for proactive decision-making and streamlined workflows.The Start of Something Amazing.
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