Computerized System Validation (CSV) Support Service

Overview

B-EN-G has the know-how of computerized system validation (hereinafter referred to as CSV) through extensive experience in building SAP ERP for the pharmaceutical industry, especially in the logistics field.
Utilizing this know-how, we support the pharmaceutical industry with system assessments, development work, maintenance of operational procedures, and verification work.

CSV Support Menu

System assessment support

• Policy/strategy review
• Initial risk assessment
• Functional risk assessment
• Supplier evaluation

Support for development work

• Support for creating development plans
• Support for creating URS, FS, DS
• Code review support
• Support for creating test plans and records

Support for maintenance of operational procedures

• Support for maintenance of operating procedures

• Support for maintenance of operating procedure manuals

  • Backup restore procedure manual, change control procedure manual, deviation management procedure manual, education and training procedure manual, self-inspection procedure manual, etc.

Verification work support

• VP (Validation Plan) creation
• Supplier auditing
• DQ (Design Qualification)
• IQ (Installation Qualification)
• OQ (Operating Qualification)
• PQ (Performance Qualification)
• VR (validation report) creation

Advantages of Contracting B-EN-G

System development compliant with CSV

• System construction know-how including pharmaceutical CSV
• Members who have taken GMP/CSV education
• System development for supplier audits 

CSV support for customer-centered projects

• Experienced CSV consultants support customers' CSV implementation
• Perform appropriate CSV according to customer requests, risks, and software
• Reduce the gap between systems department, QA department, manufacturing department and suppliers

Providing software to support manufacturing operations

• Providing various solutions to support manufacturing operations
• Supporting project execution and validation when introducing solutions
• Supports supplier audit as a solution development vendor

Also available for global projects

Related Solutions

Cloud Qualification Service
We provide qualification services when cloud services such as Microsoft Azure are adopted for infrastructure.

Microsoft Azure Qualification Practical Training for CSV Personnel
Instructors with extensive practical experience provide detailed instruction in small group settings.

CSV on AWS(Computerized System Validation on Amazon Web Service)
We provide two documents that need to be considered when applying CSV: "AWS CSV Compatibility Reference" and "AWS Supplier Checklist Reference".