Quality Assurance (QA), an independent group within Biosite, is responsible for ensuring the quality of the work provided by Biosite, and that all work is conducted in compliance with applicable GCP guidelines, relevant regulatory requirements and applicable Standard Operating Procedures (SOPs).
QA Team is also responsible for the Biosite quality management system and conducts internal system and project audits as well as vendor audits to ensure that vendors work to the same quality standards.
The Biosite auditors have many years of clinical development experience and routinely conduct GCP, Medical Device, GVP, GLP and GMP audits.
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