ACM-Pivotal’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). ACM-Pivotal is accredited with the College of American Pathologists (CAP).

Detailed standard operating procedures (SOPs) governing all critical paths are in effect. All staff has documented training records demonstrating the training received, qualifications and education. Clear audit trails, both paper and electronic, are present, and our systems comply with the FDA’s 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 internal audits are conducted 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-Pivotal welcomes client QA audits.