What is Quality Assurance (QA)?

In Japan, I feel that QA is misunderstood as Quality Audit.
In many Japanese pharmaceutical companies, it is common for approved deliverables to be audited retrospectively by sampling.
In this way, you are repeating the Checks performed by the non-audit department.
Overseas, some people ridicule the fact that in Japan, the QA department performs QC.
Ironically, the data that Japanese pharmaceutical companies use to file new drug applications is considered the most accurate because of repeated Checks.
However, it is pointed out that there is no quality assurance of business processes.
Naturally, QA stands for Quality Assurance.
What is important in QA is to review the system from a third-party perspective against regulatory requirements, your company’s policies and procedures during the planning, design, development and operation phases of the system.
It is important for the QA department to cooperate with the audited department to provide quality assurance of the process at every stage of the work.


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