Test Facility

B'SYS is organized as GLP (Good Laboratory Practice) test facility and is thus in a position to provide ion channel services in compliance with GLP principles for regulatory submission of compliant data. All GLP studies are supported by method validation procedures providing solid evidence of method suitability for regulatory purposes. B'SYS has an independent QAU (Quality Assurance Unit) for inspection of GLP studies. Study related GLP records are stored in the GLP archive including training, calibration, and maintenance record sheets. Hallmark of GLP studies are the organized study accomplishment and precise execution.

• Generation of compliant data for regulatory submission

• B'SYS is a certified Swiss GLP test facility: Swiss GLP Test Facilities

• Archiving of GLP records for 10 years

• Only trained personnel is in charge of GLP study accomplishment

• Test facility inspections by regulatory authorities every 2 years

GLP (Good Laboratory Practice) serves as quality management system concerning the organizational conditions under which non-clinical safety studies are accomplished. The test results generated in accordance with GLP principles in an OECD member country are accepted in other member countries. In the OECD Principles on Good Laboratory Practice.