Good Documents are essential for Regulatory Compliance.
Bunzen helps regulated companies and organizations in the healthcare industry with computerized system validation. Our services include creation of CSV documents, training, supplier audits.
About Us
Bunzen was established in August 2018.
Bunzen’s principal consultant, Kenichi Nakano, is a System Auditor certified by the Information-Technology Promotion Agency (IPA) of Japan. He has been providing consulting services, including Computerized System Validation and supplier audits, since 2002. He is also an active member of the eClinical Forum.
CSV consultation
Bunzen provides practical and client-focused support for regulatory compliance related to computerized systems. Our services include Computerized System Validation (CSV), incorporating risk-based approaches aligned with evolving regulatory expectations, as well as the development of policies, standards, and SOPs, supplier audits, and internal training programs.
We are committed to understanding each client’s unique environment and challenges, enabling us to deliver effective and tailored solutions.
Audit reports
Bunzen provides compliance assessment reports on leading EDC suppliers. These reports cover standard audit questions, including those outlined in the GAMP 5 guidelines, enabling regulated companies to significantly reduce the time and cost associated with supplier audits.
For more details, please refer to the brochures below:
- Viedoc Technologies AB (English / Japanese)
- CRScube, Inc. (English / Japanese)