Quality Considerations for Genotyping Studies at Epidauros

Epidauros conducts laboratory work for genotyping studies according to one common quality standard (All experimental procedures are conducted in compliance with GLP*).

With respect to documentation requirements, however, EPIDAUROS offers its genotyping services in two standards:

 

• Epidauros Basic Documentation
• GLP Documentation which complies fully with the quality requirements of Good Laboratory Practice (GLP)

 

Epidauros genotyping studies are typically used in clinical studies. Since the Good Clinical Practice (GCP) guidelines do not currently specify laboratory standards in great detail, the choice between Epidauros Basic Documentation or GLP Documentation must be based on the client’s guidelines for quality assurance activities in its clinical studies and those of associated outsourcing partners.

Epidauros recommends that the GLP Documentation be used for genotyping studies where the results will be included in official submissions to regulatory authorities and inspections by authorities can be expected.

 

For further information and assistance, please contact us. We would be pleased to supply you with more detailled information about the differences between the two documentation standards, including our ‘Quality Fact Sheet’ describing our quality systems and quality philosophy.