Our Dedication to Quality
At TruoX Laboratories, our systems, documentation, workflows, and culture are designed to ensure every result, record, and decision meets regulatory expectations.
Even as a small team, we have the knowledge and experience to function like a mature pharma company.
Quality Policy
We are committed to providing QC and software services that are:
- Scientifically sound
- Fully compliant with applicable GMP, GLP, and Health Canada requirements
- Executed through validated systems and traceable documentation
Our objective is to deliver data that are accurate, reliable, and defensible in any regulatory inspection.
Quality Management System (QMS)
TruoX operates under a structured Quality Management System designed around:
- ICH Q7–Q10 Quality and Risk Management principles
- ISO 9001 process-based management
- ALCOA+ data integrity requirements
- GAMP5 principles for GxP computerized systems
Continuous Improvement
Quality performance is monitored through:
- Management review meetings
- KPI dashboards for deviations, turnaround times, and CAPA closure rates
- Periodic requalification of systems and methods
- Lessons-learned integration from audits and inspections
These systems ensure continuous compliance, operational efficiency, and regulatory readiness.
Integration with CSV & GMP Operations
All computerized systems are validated under GAMP 5 (2nd Edition) principles and linked to the QMS for documentation control and data integrity.
Each analytical and digital workflow follows traceable validation, review, and approval paths under GMP requirements.
Commitment
Quality is the foundation of trust.
TruoX Laboratories maintains a zero-compromise approach to integrity, traceability, and reproducibility in all analytical and system activities.
Every team member shares responsibility for maintaining compliance and driving continuous improvement.