Computerized System Validation Practices 2026

Description

This is a request, not an immediate purchase. Delivery takes about one week. Your card is authorized but not charged until the English PDF is ready.

Product ID: 1165

Publisher: Johokiko

Publication Date: 2026-02-24

English Summary

The 2026 edition provides comprehensive explanations of the latest regulations, fully compliant with domestic CSV guidelines, covering PIC/S, FDA, EU GMP, CSA, and Annex 11/22 (AI). It is aimed at professionals involved in Computerized System Validation (CSV), quality assurance, quality control, regulatory affairs, IT system implementation, and compliance.

Contents / Coverage

• Chapter 1: CSV Regulations in Our Country and Their Key Points
• Chapter 2: Latest Regulatory Trends and Guidance Overseas
• Chapter 3: Data Integrity and CSV
• Chapter 4: Overview of Electronic Records and Electronic Signatures (ERES) Regulations in Pharmaceuticals and Management Concepts, Including AI Utilization
• Chapter 5: CSV Compliance in Cloud Computing
• Chapter 6: Concepts of Computerized System Validation in Pharmaceutical Distribution
• Chapter 7: Overview of Handling Electronic Data in Clinical Trials and Basic Concepts of CSV
• Chapter 8: Considerations for Data Integrity and Computerized System Validation in GLP Facilities
• Chapter 9: Concepts of Computerized System Validation in Medical Devices
• Chapter 10: Supplier Audit Compliance in CSV

Why This May Matter Internationally

This publication addresses global regulatory trends and practices in computerized system validation, making it relevant for professionals in the pharmaceutical and healthcare industries worldwide.

Keywords: Japan,technical book,Johokiko,CSV,regulations,pharmaceuticals,healthcare