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Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories
Hardcover
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ISBN13: 9781788012812
Publisher: Royal Society of Chemistry
Published: Nov 9 2018
Pages: 598
Weight: 2.60
Height: 1.80 Width: 5.60 Depth: 8.20
Language: English
Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely.
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