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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 ...
This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of ...
During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to mainta...
This new GAMP Good Practice Guide is intended to provide a risk-based approach to implementing and supporting regulated mobile apps, and will be of...
The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturi...
The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) applies a structured approach, including risk managem...
This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, an...
The ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide ...
The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records provides practical and pragmatic advice on areas such as regulated r...
The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Key Concepts provides detailed practical guidance to support data integrity within a regul...
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