An independent auditing / self-inspection department audits all of our GCP, GPSP, and GVP services
The credibility of clinical trials is ensured through GCP audits conducted by an independent team in full compliance with GCP, protocols, SOPs and other regulations and guidelines. In addition, independent audits for post-marketing surveillance and pharmacovigilance improve reliability and confirm full compliance with GPSP, GVP and SOPs.
- Point 1.
- Highly-skilled reliability assurance staff well-versed in ISO 9001 and all stages of clinical trials
- Point 2.
- Extensive experience in auditing contracts for clinical trials and research, post-marketing surveillance, and self-inspection
Main Services and Details
We audit the following:
- Pharmaceutical products, medical devices, investigator-initiated clinical trials, clinical researches
- Clinical trial sites (medical institution)
- Institutional Review Board, Ethical Committee
- In-house clinical trial works
- Self-inspection of post-marketing surveillance
- Vendors including evaluation
- SOP for auditing, check list preparation
- Staff responsible for audit dispatch
Message from Self-inspection Staff
I have extensive experience in the medical field but my recent job responsibilities are focused on reliability assurance, especially for auditing and self-inspection. My fundamental policy in performing reliability assurance follows ISO9001. The “process approach” in ISO9001 was an eye-opener for me. I now clearly understand that any operation consists of processes and the interactions amongst the processes need to be optimized and my perspective of the operation reflects this knowledge. For instance, if we focus only on the event and the relevant parties when “nonconformity” is pointed out by auditing, we will fail to take adequate measures. Fundamentally, measures should only be taken after a thorough understanding of the interrelations of the processes, all parties’ thoughts and behaviors, and the entire scope of the issues faced. It does not always work out as planned because the process of communication between different positions and organizations or involving other stakeholders may be time-consuming. However, we are committed to follow this fundamental policy under all circumstances with the goals and perspectives in mind.
S.K. has 20 years of experience in reliability assurance
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