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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.
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Fact sheet Endorsement
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