Good Documents are Essentials for Regulatory Compliance.
Bunzen helps regulated companies and organizations in the healthcare industry create documents which are required or expected for regulatory compliance; including policies, standards, Standard Operation Procedures, Manuals, and Computerized Systems Validation documents.
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.
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.
PCG Solutions, the developer of Viedoc, an Electronic Data Capture (EDC) system, asked us in 2019 to audit their software. The report covers all audit questions listed in the de-facto standard GAMP 5. Regulated companies will be able to save on auditing cost significantly by assessing it.
The assessment report (English Edition) is available now. Click here to see the summary of the assessment report.
You can contact us using the details provided.
Bunzen Co., Ltd.
Minami-dai 3-3-7-201, Minamiku
Sagamihara-shi, Japan, 252-0314