The supervisory audit mandated compliance with standards and process management
On July 22, 2019, external supervisory audit of quality systems according to ČSN EN ISO 9001:2016 took place in the Clinical-Pharmacological Unit (CPU) of the The International Clinical Research Center of St. Anne’s University Hospital Brno and Blood bank. During the surveillance audit, no errors were found that would require withdrawal of the certificates, and in the final evaluation it was recommended to retain all the certificates for the above-mentioned quality systems. This certificate confirms compliance with standards related to process management, documentation and business organization.
“The quality system is an essential part of the operation of the CPU to ensure the highest standards when testing new drugs on patients or volunteers,” added MVDr. Ing. Václav Trojan Ph.D., Head of Clinical-Pharmacological Unit. “This is another step for our unit to be able to validate the basic research findings not only of the medical cannabis we are preparing, but also of other medicines.”