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 consultant, Kenichi Nakano, is a Certified Information System Auditor (CISA) and a System Auditor certified by Japan Information-Technology Promotion Agency (IPA). He has been providing consulting service including Computerized System Validation and supplier audits since 2002. He is also Asia Pacific Facilitator of eClinical Forum.
CSV consultation
Bunzen provides pragmatic advice and support to our customers with computerized-systems-related regulatory compliance such as computerized systems validation (CSV), development of CSV policies, standards and SOPs, supplier audits, and internal training. Bunzen always tries its best to understand the customers and the situation in order to provide the optimal deliverables.
Audit reports
Bunzen conducts an independent system audit service for suppliers of regulated systems, and shares the audit report with interested parties. The report covers all standard audit questions including those listed in the GAMP 5 checklist. Regulated companies will be able to save their audit cost significantly by utilizing it.
The following audit reports are available now.
- Audit Report on Viedoc V3/V4 (English edition)
- Audit Report on Viedoc V3/V4 (Japanese edition)