The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...

The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...

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 o...

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...

This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, an...

This Guide provides a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementa...