{"product_id":"pharma-express-volume-2-laboratory-controls-data-integrity-9798243180054","title":"Pharma Express: Volume 2 Laboratory Controls \u0026 Data Integrity","description":"\u003cp\u003e • Author(s): Echoes Of Avicenna\u003cbr\u003e • Publisher: Independently Published\u003cbr\u003e • Publisher Imprint: Independently Published\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003cb\u003eLaboratory data is the foundation of regulatory trust.\u003c\/b\u003e\u003cbr\u003e\u003ci\u003ePharma Express - Volume 2: Laboratory Controls \u0026amp; Data Integrity\u003c\/i\u003e delivers a clear, inspection-ready guide to how pharmaceutical laboratories are expected to operate-and how regulatory confidence is built, tested, and lost through data.\u003cbr\u003eWritten in a modern, bullet-first format, this volume focuses on the laboratory as a \u003cb\u003econtrol system\u003c\/b\u003e, not just a testing function. It translates regulatory expectations into real-world laboratory behavior, covering how data is generated, reviewed, protected, investigated, and retained across its full lifecycle. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003eThis book avoids unnecessary theory and legal complexity. Instead, it concentrates on what inspectors actually assess: systems, patterns, controls, and decision-making under pressure. \u003cp\u003e\u003c\/p\u003e\u003cb\u003eInside this volume, readers will learn: \u003c\/b\u003e\u003cul\u003e\n\u003cli\u003eHow regulators evaluate \u003cb\u003elaboratory controls and data integrity\u003c\/b\u003e\n\u003c\/li\u003e\n\u003cli\u003eWhat \u003cb\u003eALCOA+\u003c\/b\u003e really means in daily laboratory operations\u003c\/li\u003e\n\u003cli\u003eHow to manage \u003cb\u003eOOS, OOT, invalidations, and retesting\u003c\/b\u003e without compromising integrity\u003c\/li\u003e\n\u003cli\u003eThe difference between \u003cb\u003eerror, fraud, and poor systems\u003c\/b\u003e\n\u003c\/li\u003e\n\u003cli\u003eWhy audit trails, access control, and validation matter more than policies\u003c\/li\u003e\n\u003cli\u003eHow warning letter patterns emerge-and how to avoid them\u003c\/li\u003e\n\u003c\/ul\u003eDesigned for professionals who must defend laboratory data during inspections, this book provides practical insight into \u003cb\u003ewhat works, what fails, and why enforcement happens\u003c\/b\u003e. \u003cp\u003e\u003c\/p\u003eIf laboratory data supports your product decisions, this book belongs on your desk. \u003cp\u003e\u003c\/p\u003eThis book is provided for educational and informational purposes only. The author and publisher do not guarantee that the content reflects all current regulatory requirements. Readers are responsible for verifying and complying with all applicable laws, regulations, and industry standards.","brand":"Independently Published","offers":[{"title":"Paperback","offer_id":47595117084823,"sku":"9798243180054","price":4967.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9798243180054.webp?v=1774988484","url":"https:\/\/atlanticbooks.com\/products\/pharma-express-volume-2-laboratory-controls-data-integrity-9798243180054","provider":"Atlantic Books","version":"1.0","type":"link"}