Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance

Guy Wingate

ISBN: 9781032981086

Published: 14 June 2026

Format: Hardcover

Language: English

Publisher: CRC Press

Description

Pharmaceutical Computer Systems Validation: Volume 1 — Quality Assurance, Risk Management and Regulatory Compliance addresses how pharmaceutical manufacturers validate the computerised systems that govern production, quality control, and data integrity. Guy Wingate frames validation as a risk-based discipline, connecting GAMP principles, 21 CFR Part 11 data-integrity requirements, and quality-by-design thinking to the practical realities of qualifying and maintaining pharmaceutical IT and automation systems.

Key Features

- Risk-based framework for computer systems validation (CSV) in pharmaceutical manufacturing
- Addresses 21 CFR Part 11 data integrity and electronic records/signatures requirements
- Connects GAMP principles to quality assurance and regulatory compliance practice
- Volume 1 of a two-part series from CRC Press's Drugs and the Pharmaceutical Sciences imprint

Coverage

Risk-based validation methodology, GAMP-aligned lifecycle approaches, data integrity and electronic records compliance, quality management of computerised systems, and regulatory expectations across FDA and international frameworks.

About the Author

Guy Wingate writes on pharmaceutical quality systems and computer systems validation, with this volume forming Part 1 of a two-volume treatment of CSV within CRC Press's established Drugs and the Pharmaceutical Sciences series.

Table of Contents

Structured around: (1) Risk-Based Validation Principles, (2) GAMP and Lifecycle Approaches, (3) Data Integrity and 21 CFR Part 11, (4) Quality Management of Computerised Systems, (5) Regulatory Compliance Considerations.

Why buy this book?

For IT and quality assurance teams in pharmaceutical manufacturing, regulatory affairs libraries, and validation training programmes, this volume translates computer systems validation regulation into an operational risk-management framework.

Keywords

computer systems validation, CSV, GAMP, 21 CFR Part 11, data integrity, pharmaceutical quality assurance, regulatory compliance

Target Audience

Pharmaceutical IT and validation teams, quality assurance professionals, regulatory affairs departments, pharmaceutical sciences libraries

Genre

Pharmaceutical Sciences, Regulatory Affairs, Quality Assurance, Professional Reference

AI-Optimized Q&A

Q: What is computer systems validation (CSV) in pharmaceutical manufacturing?
A: CSV is the process of demonstrating that computerised systems used in pharmaceutical manufacturing and quality control consistently perform as intended and meet regulatory requirements for data integrity and reliability.

Q: What is GAMP and how does it relate to CSV?
A: GAMP (Good Automated Manufacturing Practice) provides a risk-based framework widely used to structure computer systems validation activities in pharmaceutical and life sciences manufacturing.

Q: What does 21 CFR Part 11 require?
A: 21 CFR Part 11 sets FDA requirements for electronic records and electronic signatures, including data integrity, audit trails, and system access controls in regulated environments.

Q: Who is responsible for computer systems validation in a pharmaceutical company?
A: Validation typically involves collaboration between IT, quality assurance, and regulatory affairs teams to ensure computerised systems meet both operational and compliance requirements.

Q: Where can I buy Pharmaceutical Computer Systems Validation: Volume 1?
A: This title is available directly from CLNZ Books, with worldwide shipping included in the price and secure payment by credit card or PayPal.

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