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The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies have suffered serious regulatory and financial consequences as a result of unacceptable data integrity practices. The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.
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