How do we build quality in at Agilex Biolabs?
Agilex Biolabs is committed to integrating our processes with quality principles to ensure quality outcomes.
Quality Management System
Agilex Biolab’s electronic quality management system (eQMS) provides a standardized approach to; control our documented procedures, identify and reduce risks, prevent recurrence of errors and ensure quality.
Our chosen eQMS platform is trusted by life sciences companies worldwide and provides us with a fully validated set of quality and compliance processes, and complies with standards such as ISO/IEC 17025, 21 CFR Part 11, and ISO/IEC 27001.
Quality Planning & Review
Annually, we evaluate the performance and effectiveness of our quality processes to; determine and set key quality indicators, and develop actions for continued quality process improvement. The key quality indicators and their set criteria, and the process improvement actions are reviewed, measured, reported and communicated at the operational management level quarterly to ensure our ongoing commitment to quality is being achieved.
Continuous Improvement
Continuous improvement is integral to Agilex Biolabs’s quality culture, and is facilitated through the quality unit by:
- Applying a risk based approach to quality processes
- Proactively and rapidly identifying, documenting, investigating and resolving quality issues
- Monitoring the effectiveness of corrective actions to ensure the root causes have been addressed
- Managing the customer audit program and actioning improvement opportunities from findings and recommendations
- Oversight of change control implementation
Audit Readiness
The quality assurance audit program is designed to assess how well our processes and procedures comply and conform with regulatory requirements. The audit program is an independent assessment of operational processes, ensuring compliance and identifying opportunities for improvement.
Agilex Biolab’s adopts a collaborative approach to meeting our customers assessment requirements. Contact us to schedule an on-site or remote audit, study monitoring, or questionnaire completion.
