GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and…
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1° Guía de Buenas Prácticas en Español Las Baselines Guides de ISPE ofrecen sustento técnico para realizar, operar y mantener instalaciones acorde a normativas cGMP.
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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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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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The ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide a risk-based approach to validating diverse computerized GCP systems in compliance with applicable regulations. With the emergence of new technologies,…
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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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