SpinoS commitment to quality is paramount, and is built into all of our activities. Our Quality Assurance System is founded on the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP), the MHRA guidance for Good Clinical Practices Laboratories, and FDA principles for quality systems.
Detailed standard operating procedures (SOPs) governing all critical paths are in effect. All staff have documented training records demonstrating the training received, qualifications and education. Our record-keeping practices, both paper and electronic are fully compliant with GCP, and our electronic systems comply with the FDA 21 CFR Part 11.
Precision and reproducibility of analytical data are ensured by regular monitoring of internal Quality Control results as well as by participation in a number of national and international External Quality Assessment Schemes.
Quality control procedures are in place to ensure continuous accurate data recording. In addition, comprehensive internal audits of all departments are conducted annually by our independent Quality Assurance Group.
- System audits
- Facility audits
- Quality systems audits
- Data integrity audits
- For cause audits
- Study audits at request
- Supplier audits
SpinoS welcomes client QA auditors anytime.
The entire management team shares a commitment to continuous process improvement and seeks to partner with our clients to measure and execute quality vendor services.