Quality Assurance (QA) is an independent function that reports to the top management. The goal of QA is to promote excellence by ensuring adherence to ICH – GCP and SOPs. The team ensures that the ethical conduct of the clinical study, documentation and reporting of the data is in compliance with ICH-GCP and regulatory guide lines.
The documentation is facilitated by use of checklists and forms for reporting observations and deviations. The QA team also prepares audit reports and compliance reports.
The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data generated. The verification process is specified and justified with the in-house systems, procedures and applicable regulatory guidelines.