Publicaciones

GAMP Guide: Records & Data Integrity

Publicaciones

The importance of ensuring 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 pharmaceutical data integrity practices. The…

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GAMP Good Practice Guide: Electronic Data Archiving

Publicaciones

This Guide provides a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of such a strategy should assist organizations to achieve and maintain regulatory compliance, and to more effectively manage electronic…

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GAMP Good Practice Guide: Calibration Management

Publicaciones

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance.…

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