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 ...

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 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...

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...

The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration manage...

The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not m...

The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not m...

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