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Books > Science & Mathematics > Science: general issues > Scientific standards
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Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories (Hardcover)
Loot Price: R4,194
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Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories (Hardcover)
Expected to ship within 10 - 15 working days
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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. The aim of this book is to provide
practical and detailed help on how to implement data integrity and
data governance for regulated analytical laboratories working in or
for the pharmaceutical industry. It provides clarification of the
regulatory issues and trends, and gives practical methods for
meeting regulatory requirements and guidance. Using a data
integrity model as a basis, the principles of data integrity and
data governance are expanded into practical steps for regulated
laboratories to implement. The author uses case study examples to
illustrate his points and provides instructions for applying the
principles of data integrity and data governance to individual
laboratory needs. This book is a useful reference for analytical
chemists and scientists, management and senior management working
in regulated laboratories requiring either an understanding about
data integrity or help in implementing practical solutions.
Consultants will also benefit from the practical guidance provided.
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