Getting to the Nitty Gritty of GAMP Guidelines for Software Validation
Our Senior Regulatory Expert Paul Daniel has outlined 10 steps to validating system software according to a guidance publication from the International Society for Pharmaceutical Engineering (ISPE).
In this one-hour webinar, Paul will outline a ten-step method for applying the GAMP methodology to the validation of your monitoring system software. The key learning objective is to help you simplify the GAMP approach and identify any steps you can take to integrate your validation efforts into your existing quality management systems.
Paul will also show how the level of effort required in validation processes is dependent upon system complexity (referring to GAMP System Categories). Paul will show how a GAMP approach to validation is aimed at increasing the lifespan, usability, and compliance of your monitoring system software.
Join us at noon (EST) on November 12, 2015. In the meantime, please review this infographic (shown right) that outlines 10 steps to system validation...