Quality - internally

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).

The objectives of QAU are:

  • Internally: ensure a constant quality of PK/TK analysis and reporting
  • Externally: assist clients on questions regarding quality and quality systems

Internally 

  • Kinesis' quality system is based on the OECD GLP Guidelines (Kinesis is GLP-certified since January 2004)
  • Study-related audits are performed during all critical phases (GLP)
  • On request of the Sponsor audits can be performed on different phases of non-GLP studies
  • All procedures are described in SOPs, which are managed by the QAU
  • Facilities are audited according to a predefined plan
  • Audits of validated computerized systems are performed on a regular basis.
Quality

Fact sheet   Endorsement

factsheet

endorsement