Quality Assurance Department
The Quality Assurance Department (QA) at Kinesis is responsible for the Quality System, which is based on the EU requirements of quality in a GxP operating environment and which will focus on the aspects that have to be in compliance in order to perform GxP compliant work (GLP/GCP) according to EU Directive 2004/10/EC; EU Directive 2001/20/EC and Directive 2001/83/EC, as amended, and if applicable Directive 2003/94/EC and ICH E6).
The Non-clinical department of Kinesis has been inspected several times by the Dutch GLP Inspectorate (IGZ) and, in September 2013, the endorsement of Good Laboratory Practice compliance was obtained for the fifth consecutive time. The involvement of the Kinesis QA department in studies is significant. All studies are performed according to standard operating procedures (SOPs) using validated software. For GLP studies all critical phases such as the study plan, study procedures, raw data and the final report are audited. On request of the Sponsor audits can be performed on different phases of non-GLP studies as well. Additionally, the QA inspection program includes periodic auditing of facilities, computerized systems, Trial Master Files and all procedures and processes.