Integrated EQMS for Biotechnology
Discover how a cloud-based EQMS can streamline compliance, accelerate production, and ensure the highest standards for gene therapies, and other groundbreaking innovations. Don’t let outdated systems hold back your scientific breakthroughs. From GMP to ICH guidelines, managing biotech quality has never been easier. Experience how a modern EQMS can simplify traceability, mitigate risks, and keep your lab, production, and compliance teams in sync—all while boosting efficiency.
Transforming Biotechnology Quality Management for a Smarter, Better, and Safer Tomorrow
Biotechnology is at the forefront of solving humanity’s greatest challenges, but with groundbreaking innovation comes unparalleled complexity. Managing sensitive biologic products, adhering to multifaceted regulatory requirements, and ensuring process integrity demand more than traditional systems can offer. Qualityze EQMS Solutions empowers you with intelligent, cloud-based solutions for quality, safety, and compliance. Our platform integrates seamlessly with your processes to optimize batch consistency, validate workflows, and navigate global regulatory demands—all while enabling real-time visibility and proactive decision-making. With Qualityze, you’ll harness the power of digital transformation to deliver safer, more effective products faster.
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The Qualityze Difference Empowers You To:
Navigate Complex Regulatory Landscapes
Streamline compliance with global regulatory requirements, including FDA, EMA, and PMDA standards. Our solution simplifies multi-regional compliance with configurable workflows, automated documentation, and real-time visibility into your regulatory obligations.
Maintain Full Traceability of Unique Raw Materials
Our EQMS ensures full traceability for biotech-specific raw materials such as cell lines and growth media. From procurement to production, gain a comprehensive view of your supply chain to meet compliance requirements and ensure material integrity.
Manage Complex Product Lifecycles Effectively
Track and control quality across the entire lifecycle of your products, from R&D to post-market surveillance. Our system integrates real-time data, robust reporting, and scalable workflows to support the unique lifecycle needs of biotech innovations.
Mitigate High Risks of Non-Compliance
Reduce the financial and reputational risks of non-compliance with proactive risk management capabilities. Our EQMS helps you identify and mitigate potential quality issues before they impact product safety or regulatory approval.
Conduct Robust Post-Market Surveillance for Advanced Therapies
Simplify post-market surveillance with real-time data integration and automated workflows for tracking adverse events, monitoring long-term safety, and maintaining compliance with regulatory requirements for gene therapies and biologics.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 9001 | General Quality Management System Requirements |
| ISO 13485 | Quality Management for Medical Devices (for biotech products used in medical applications) |
| ISO 14971 | Risk Management for Medical Devices |
| ISO 31000 | Risk Management Principles and Guidelines |
| ISO 22716 | Good Manufacturing Practices (GMP) for cosmetics (applicable to biotechnology-derived cosmetic ingredients) |
| FDA Regulations | |
| 21 CFR Part 11 | Electronic Records and Signatures |
| 21 CFR Part 58 | Good Laboratory Practice (GLP) |
| 21 CFR Part 210/211 | Current Good Manufacturing Practice (cGMP) for Drugs |
| 21 CFR Part 600 | Biological Product Standards |
| 21 CFR Part 820 | Quality System Regulation for Combination Products |
| GxP Guidelines | |
| Good Manufacturing Practices (GMP) | For manufacturing and production of biologics and other biotech products |
| Good Laboratory Practices (GLP) | For preclinical research and testing |
| EU Regulations | |
| EU GMP Annex 1 | Manufacture of Sterile Medicinal Products |
| EU MDR | Medical Device Regulation (for biotechnology products used in medical devices) |
| EU IVDR | In Vitro Diagnostic Regulation |
| ICH Guidelines | |
| ICH Q5 | Quality of Biotechnological Products |
| ICH Q6B | Specifications for Biotechnological/Biological Products |
| ICH Q9 | Quality Risk Management |
| ICH Q10 | Pharmaceutical Quality System |
| Pharmacovigilance and Safety Monitoring Standards | |
| ICH E2E | Pharmacovigilance Planning |
| EMA Good Pharmacovigilance Practices (GVP) | |
| WHO Guidelines | |
| WHO Guidelines on the Regulation of Biological Medicines | |
| WHO Laboratory Biosafety Manual | Biosafety and Biosecurity Guidelines |
| Environmental and Ethical Standards | |
| OECD Guidelines for Biotechnology | |
| ISO 14001 | Environmental Management Standards |
Reasons to choose Qualityze EQMS for Biotechnology Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Biotechnology 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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