Visual Sample Tracking and Management Software Visual Sample Tracking and Management Software
GAMP

GAMP 4 is the most widely used, internationally accepted, guideline for validation of computer systems.processes. More than 70 healthcare professionals, from the Americas and Europe, participated in the production of GAMP 4 by contributing to groups producing new and revising existing material.

GAMP 4 is intended for suppliers and users in pharmaceutical manufacturing and related healthcare industries such as biotechnology and medical device. The Guide draws together key principles and practices and describes how they can be applied to determine the extent and scope of validation for different types of automated systems.   One of the key areas is suppliers and their quality systems.

 

The supplier must build quality into their software in the form of robustness and quality documentation, and should be assessed to determine the adequacy of their development and support processes.  GAMP4 details four stages in the audit cycle as follows: - Preliminary Assessment, Detailed Audit, Follow-up Audit and Surveillance Audit.

Our validation specialists can assist or carry out all of the above elements with engineering experts who are used to working with suppliers.