ISPE announced the release of the latest guidance document ISPE GAMP® Guide: Records and Data Integrity. This guide provides an overview of principles and practical guidance on meeting current expectations for the management of GxP regulated records and data—ensuring they are complete, consistent, secure, accurate, and available throughout their life cycle.
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FDA Guidance Answers Questions Regarding Data Integrity by David Jensen, Marketing Communications Specialist, MasterControl An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to […]
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FDA published a guidance for Data Integrity and Compliance with CGMP, which answers data integrity questions in the hope of clarifying what FDA expects from manufacturers in order to reduce the amount of violations of data integrity.
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