Quality Assurance Unit
The Quality Assurance Unit (QAU) at Kinesis is responsible for the Quality System, which is based on the OECD Guidelines of Good Laboratory Practice (GLP). In this respect, Kinesis has already been inspected several times by the Dutch GLP Inspectorate (Voedsel- en Waren Autoriteit) and, in September 2011, the endorsement of Good Laboratory Practice compliance was obtained for the fourth 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, facilities are audited according to a predefined plan and audits of validated computerized systems are performed on a regular basis.