Quality Assurance Commitment
ACM Global Central Lab's 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. ACM is accredited with the College of American Pathologists (CAP).
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. ACM Laboratory technical staff successfully performs more than 15,000 proficiency test challenges annually.
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. Audits include:
- System audits
- Facilities audits
- Quality systems audits
- Data integrity audits
- For cause audits
- Study audits at request
- Supplier audits
ACM welcomes more than two dozen client QA auditors annually.
ACM Global has a business-wide process improvement program, led by a Lean/Six Sigma certified Black Belt. 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.
ACM Global Central Laboratory complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. ACM Global Central Laboratory has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view ACM Global Central Laboratory's certification, please visit http://www.export.gov/safeharbor/