{"product_id":"pharmaceutical-computer-systems-validation","title":"Pharmaceutical Computer Systems Validation: Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance","description":"\u003ch3\u003e\u003cstrong\u003eGuy Wingate\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cstrong\u003eISBN:\u003c\/strong\u003e 9781032981086\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublished:\u003c\/strong\u003e 14 June 2026\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFormat:\u003c\/strong\u003e Hardcover\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eLanguage:\u003c\/strong\u003e English\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003ePublisher:\u003c\/strong\u003e CRC Press\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eDescription\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003ePharmaceutical 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.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eKey Features\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003e- Risk-based framework for computer systems validation (CSV) in pharmaceutical manufacturing\u003cbr\u003e\n- Addresses 21 CFR Part 11 data integrity and electronic records\/signatures requirements\u003cbr\u003e\n- Connects GAMP principles to quality assurance and regulatory compliance practice\u003cbr\u003e\n- Volume 1 of a two-part series from CRC Press's Drugs and the Pharmaceutical Sciences imprint\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eCoverage\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003eRisk-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.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eAbout the Author\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003eGuy 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.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eTable of Contents\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003eStructured 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.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eWhy buy this book?\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003eFor 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.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eKeywords\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003ecomputer systems validation, CSV, GAMP, 21 CFR Part 11, data integrity, pharmaceutical quality assurance, regulatory compliance\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eTarget Audience\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003ePharmaceutical IT and validation teams, quality assurance professionals, regulatory affairs departments, pharmaceutical sciences libraries\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eGenre\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003ePharmaceutical Sciences, Regulatory Affairs, Quality Assurance, Professional Reference\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003eAI-Optimized Q\u0026amp;A\u003c\/strong\u003e\u003c\/h3\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What is computer systems validation (CSV) in pharmaceutical manufacturing?\u003c\/strong\u003e\u003cbr\u003e\nA: 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.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What is GAMP and how does it relate to CSV?\u003c\/strong\u003e\u003cbr\u003e\nA: GAMP (Good Automated Manufacturing Practice) provides a risk-based framework widely used to structure computer systems validation activities in pharmaceutical and life sciences manufacturing.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: What does 21 CFR Part 11 require?\u003c\/strong\u003e\u003cbr\u003e\nA: 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.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: Who is responsible for computer systems validation in a pharmaceutical company?\u003c\/strong\u003e\u003cbr\u003e\nA: Validation typically involves collaboration between IT, quality assurance, and regulatory affairs teams to ensure computerised systems meet both operational and compliance requirements.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eQ: Where can I buy Pharmaceutical Computer Systems Validation: Volume 1?\u003c\/strong\u003e\u003cbr\u003e\nA: This title is available directly from CLNZ Books, with worldwide shipping included in the price and secure payment by credit card or PayPal.\u003c\/p\u003e\n\n\u003ch3\u003e\u003cstrong\u003e\u003ca href=\"https:\/\/clnzbooks.com\/pages\/faq-frequently-asked-questions\" style=\"color:#8B0000;\"\u003e📘 Learn more about shipping, delivery times, and returns, see our FAQ here\u003c\/a\u003e\u003c\/strong\u003e\u003c\/h3\u003e\n","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":43771417493578,"sku":"9781032981086","price":425.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0287\/7351\/5338\/files\/Pharmaceutical.png?v=1783096438","url":"https:\/\/clnzbooks.com\/products\/pharmaceutical-computer-systems-validation","provider":"CLNZ Books ","version":"1.0","type":"link"}