Compliance with the regulated requirements (e.g. by EMA, FDA) is monitored via an implemented quality system, which is established to manage the company quality policies, procedures, and processes, as well as continuous improvement. The pharmaceutical quality system assures that the desired product quality is routinely met, and suitable process performance is achieved. The evidence of conformity is provided e.g. by procedures, protocols and linked documents for all operational processes from material acquisition, production, and testing to storage, import/export and market placement.