Quality Management System (QMS)
A controlled quality operating model for reliable biosafety and CMC testing across biologics, vaccines, viral vectors, and cell and gene therapy programs
Controlled execution from sample receipt to final report
People
HyQure manages personnel qualification and role-based responsibilities to support reliable biosafety and CMC testing execution.
- Training & Personnel Qualification
- Competency Confirmation
- Role definition
- Access control
- Retraining when procedures, methods, or systems change
Equipment
HyQure controls equipment and computerized systems through qualification, maintenance, access governance, and lifecycle management.
- Calibration & Maintenance
- Qualification
- Computerized System Validation
- Account and Access Control
- Audit Trail in critical instruments
- Controlled retirement or replacement
Materials
HyQure applies controlled material handling from receipt to release, storage, traceability, and expiry monitoring.
- Receipt
- Risk assessment & Classification Management
- Testing, Release & CoA
- Storage Expiry Monitoring
- Traceability
Methods
HyQure supports method selection, validation, transfer, and fit-for-purpose suitability assessment for customer-specific testing programs.
- Method selection
- Comprehensive Method Validation Package
- Method Transfer
- Suitability assessment aligned with assay purpose and sample matrix
- Client-Customized Methods or Proprietary Methods
Environment
HyQure controls laboratory environment and biosafety workflows to reduce contamination risk and support reliable testing execution.
- Biosafety and contamination prevention
- Laboratory access control
- Cleaning and environmental monitoring where applicable
Documents & Records
HyQure's documentations and records system is designed to meet global GxP and ISO/IEC 17025 expectations, where applicable. Its key features include:
- A four-tier pyramid-style documentation and record architecture
- Controlled issuance and return of documents and records
- Full lifecycle management of documents and records
- Good Documentation Practices (GDP)
- Archiving and archive room management
Regulations Compliance
HyQure's quality system is aligned with the following international and local regulations and guidelines, including Global GxP Framework for Pharmaceuticals and others：
- Good Manufacturing Practices (GMP China)
- FDA 21 CFR Part 210-211 (cGMP)
- 21 CFR Part 58 (FDA GLP guideline)
- 21 CFR Part 11 eSignature
- EU GMP and Annex
- WHO GMP guidelines
- ISO/IEC 17025 (CNAS) and specific field requirements
Four-level document system
Policy → SMP → SOP/WI → Records.
Lifecycle quality controls
including but not limited to:Personnel training; equipment lifecycle,material control,method validation/verification,environmental control,deviation,CAPA,change control,internal audit,management review,data integrity and so on.
How this strengthens HyQure internationally
HyQure presents QMS capability as a practical customer-service advantage: controlled execution, traceable documentation, audit-ready reports, and clear regulatory-facing support for global biologics, vaccine, viral vector, and CGT programs.
Why customers can rely on this QMS
International sponsors need more than test results. They need controlled sample handling, qualified people, qualified equipment, validated or verified methods, traceable materials, controlled records, and documentation that can support supplier qualification and regulatory technical review.
Related HyQure services
Analytical Development & Validation
Plan a quality-driven testing package
Share product type, development phase, target market, sample type, method status, and expected report format. HyQure can help align scope, documentation, and timeline before project initiation.
Official regulatory reference links
- FDA 21 CFR Part 58
- FDA 21 CFR Part 210
- FDA 21 CFR Part 211
- FDA 21 CFR Part 11
- EU GMP Annex 11
- WHO GMP Guidelines
- ICH Quality Guidelines
- ICH Q9(R1) PDF
- ICH Q10 PDF
- ISO/IEC 17025:2017 Standard
- ISO 9001:2015 Standard