{"product_id":"data-integrity-and-compliance-jos-rodrguez-prez-9780873899871","title":"Data Integrity and Compliance: A Primer for Medical Product Manufacturers","description":"Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e José Rodríguez-Pérez\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0873899873\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780873899871\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e ASQ Quality Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/08\/2019\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 274\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.18lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.63d","brand":"José Rodríguez-Pérez","offers":[{"title":"Hardcover","offer_id":45180509290751,"sku":"9780873899871","price":60.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_53b5ca54-97f3-4ab4-bcac-d97c6186c1c4.jpg?v=1712898089","url":"https:\/\/www.whiterainbookhouse.com\/products\/data-integrity-and-compliance-jos-rodrguez-prez-9780873899871","provider":"WR Book House","version":"1.0","type":"link"}