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Computer System Validation (CSV) Consulting
in the GMP Field

A simple description of Computer System Validation is assurance through objective evidence that a computer system will consistently perform user functions as expected.

Specifically,documentation providing evidence concerning the following qualifications and verifications:

  • Does the completed system work as expected?
  • Is the system design process properly controlled?
  • Can the assured state be maintained?
  • Can the results and assessments of qualifications and verifications adequately assure functionality?
Yoshio Takeuchi

Areas of Guidance and Support


Step-by-step guidance and progress management for the MHLW (Ministry of Health, Labor and Welfare) ERES and FDA 21 CFR Part 11 policies, including creating compliance implementation plans.
2. Explanation and interpretation of MHLW ERES and FDA 21 CFR Part 11 policies for electronic information management.
3. Guidance on carrying out computer system validation and document management.
4. Support in the management of working teams.
5. Guidance on the creation and review of control standards and procedures.

Specialty Areas of Consulting:
1. GMP Compliance
Quality Assurance System for Pharmaceutical Products.
Quality Control at Pharmaceutical Manufacturing Sites.
Interpretation of related regulations and rules.
GMP Practices (GMP System Evaluation, Continuous Improvement, Management, Training Plans)
GMP System Restructuring (Organization Restructuring, Creation of Standards・SOPs)
2. Computer System Validation (Software Validation)

Related Training
Guidance on Computer System Validation Implementation
Guidance on Management of GMP-related Computer System (Software) Development

3. FDA 21 CFR Part 11 Compliance

Interpretation of FDA 21 CFR Part 11
FDA 21 CFR Part 11 Compliance Guidance

4. MHLW ERES (Electro-magnetic Records and Electronic Signatures) Compliance.

ERES (Electro-magnetic Records and Electronic Signatures) Interpretation
ERES (Electro-magnetic Records and Electronic Signatures) Compliance Guidance

Example of Implementing an Improvement Plan

This plan is implemented with the participation of Executives, Middle Management and all employees.
Each of the steps below are followed and implementation supported.

Preliminary Stage

GMP Evaluation
Determine Issues
Improvement Plan Outline

Stage 1 (Establish Plan for Inspection and Improvement)

Explanation the new GMP system to management
General GMP Inspection
Determine Issues
Establish Improvement Plan

Stage 2 (Improve the GMP System)

Provide detailed explanation of GMP and GMP trends to all employees
Confirm and modify the improvement plan based on GMP Self Inspections
Promote improvement plans for individual themes.
Implement the new GMP management system (Standards and SOPs)

Stage 3: Consolidation of the new GMP System

Regular Education and Training Plan
Repeat the improvement cycle using periodic self inspections
Document Management System

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