AID quality management system – Supporting your drug studies

The pillars of our quality management system to support your drug studies are:

• GCLP*-compliance of all procedures carried out in our service laboratory
• Highly trained, skilled and experienced personnel
• Highest patient safety by consistent sample management and maximum data integrity
• Extensive assay validation and peer-review for all (experimental) procedures
• GxP compliant documentation from sample receipt via reporting and data transfer to archiving
• Application of validated computerized systems
• Internal quality assurance by regular monitoring of all laboratory procedures (SOPs) by QA personnel
• Implemented risk management
• Change and deviation management (CAPA)
• Open, efficient and solution-oriented communication with our customers

_{* European Medicines Agency “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.” EMA/INS/GCP/532137/2010, GCP Inspectors Working Group Adoption July 28, 2012.}