Integrated EQMS for Biologics
Explore how a next-generation, AI powered EQMS transforms biologics manufacturing with automated workflows, real-time monitoring, and seamless regulatory compliance for standards like FDA 21 CFR Part 1271 and ICH Q10. It empowers your team to tackle contamination risks, cold chain complexities, and batch variability effectively and efficiently. See for yourself how EQMS makes biologics quality challenges a thing of the past.
Biologics Without Boundaries: Redefine Quality, Safety, and Compliance with EQMS
Biologics manufacturing operates at the cutting edge of science and technology, where even minor deviations can lead to significant quality risks. Our platform equips biologics companies with the tools they need to overcome these challenges, ensuring consistent product quality and regulatory compliance throughout the product lifecycle. From risk-proofing supply chains to ensuring aseptic conditions and batch-specific traceability, we help you meet the highest standards of safety and efficiency. Compliant with ISO 9001, GMP, and biosimilar regulations, our solutions streamline critical processes like quality control, post-market surveillance, and training management to enable operational excellence.
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The Qualityze Difference Empowers You To:
Streamline Personalized Biologics Workflows
Optimize processes for patient-specific therapies like CAR-T with configurable workflows for small-batch production. Our EQMS simplifies tracking, documentation, and compliance for personalized biologic products.
Improve Workforce Training for Biologic Expertise
Empower your workforce with tailored training programs for biologic sciences and bioprocessing. Qualityze Training Management integrates role-based training, certifications, and competency tracking to ensure regulatory compliance and operational excellence.
Optimize Post-Market Surveillance for Biologics
Enhance post-market surveillance with real-time adverse event monitoring, proactive risk management, and automated regulatory reporting. Our solution supports compliance with pharmacovigilance standards and long-term safety monitoring requirements.
Ensure Cold Chain Integrity
Centralize cold chain logistics management to safeguard temperature-sensitive biologics during transportation and storage. Our EQMS integrates real-time tracking and alert systems to prevent quality loss and ensure compliance with Good Distribution Practices (GDP).
Simplify Supplier Qualification for Specialized Materials
Streamline supplier qualification with automated risk assessments, performance reviews, and pre-defined workflows. Our system ensures reliable sourcing for rare and high-cost raw materials while maintaining compliance with stringent quality standards.
Mitigate Contamination Risks in Biologic Manufacturing
Implement stringent contamination controls with pre-configured workflows for aseptic processing, environmental monitoring, and microbial testing. Our EQMS helps you maintain compliance with global GMP standards while reducing the risk of microbial and viral contamination.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 13485 | Quality Management for Medical Devices, Applicable to Biologics Used in Combination Products |
| ISO 9001 | General Quality Management System Requirements to Ensure Operational Excellence |
| ISO 31000 | Risk Management Principles and Guidelines for Managing Risks Across Biologics Processes |
| ISO 14644 | Cleanrooms and Associated Controlled Environments Standards for Sterile Manufacturing |
| ISO 10993 | Biological Evaluation of Medical Devices, Relevant for Combination Biologics |
| FDA Regulations | |
| 21 CFR Part 11 | Electronic Records and Electronic Signatures Compliance for Biologics Documentation |
| 21 CFR Part 58 | Good Laboratory Practice (GLP) for Biologics Testing |
| 21 CFR Part 210/211 | Current Good Manufacturing Practices (cGMP) for Biologic Drug Products |
| 21 CFR Part 600-680 | Biological Products Regulations, Including Licensing, Reporting, and Testing |
| 21 CFR Part 1271 | Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| GxP Guidelines | |
| GMP | Good Manufacturing Practices: Applicable to the Production, Control, and Distribution of Biologics |
| GLP | Good Laboratory Practices: For Testing and Validation in Biologics Research |
| GCP | Good Clinical Practices: For Biologics Undergoing Clinical Trials |
| GDP | Good Distribution Practices: For Managing Biologics Cold Chain Logistics |
| EU Regulations | |
| EU GMP Annex 1 | Guidelines for the Manufacture of Sterile Medicinal Products, Critical for Biologics |
| Advanced Therapy Medicinal Products (ATMPs) | Regulations for Gene Therapy and Cell-Based Biologics |
| ICH Guidelines | |
| ICH Q5A-E | Guidelines Specific to the Quality of Biotechnological Products, Including Viral Safety and Stability |
| ICH Q6B | Specifications for Biologics, Including Testing Methods |
| ICH Q8 | Pharmaceutical Development for Biologics |
| ICH Q9 | Quality Risk Management Tailored to Biologic Products |
| ICH Q10 | Pharmaceutical Quality System to Ensure Quality Across Biologics Lifecycle |
| ICH E6 | Good Clinical Practices (GCP) for Biologics Clinical Trials |
| Pharmacovigilance Standards | |
| ICH E2E | Pharmacovigilance Planning for Biologics Safety Monitoring |
| EMA Good Pharmacovigilance Practices (GVP) | Specific Modules for Biologics, Including Risk Management Plans (RMPs) |
| WHO Guidelines on Safety Monitoring | Post-Market Surveillance for Biologics |
| Global Safety and Healthcare Guidelines | |
| USP <1046> | Cell and Gene Therapy Products |
| USP <787> | Subvisible Particulate Matter in Therapeutic Protein Injections |
| USP <800> | Hazardous Drug Handling in Biologics Production |
| Biosimilar Guidelines | FDA and EMA Pathways for Biosimilar Development and Approval |
| Ph. Eur. Monographs | European Pharmacopoeia Standards for Biologic Substances |
Reasons to choose Qualityze EQMS for Biologics Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Biologics 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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