Last month, this column began exploring the following three fundamental options for when the commissioning professional prepares customized functional performance test procedures for a project. During ...

“All people involved must be impressed with the importance of the development project and the seriousness of the endeavor. They must be made to understand that violations of the procedures will have ...

The following guidelines should be used when setting up new programs or making changes to existing programs. These guidelines aim to better support schools and departments and to provide a seamless ...

This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...

ANSI/ISA-106.00.01, Procedure Automation for Continuous Process Operations, has been published by ISA. The standard sets forth mod­els, styles, strategies, philosophies, and life cycle for the ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...

See how BioDlink’s digital-intelligence platform is driving three major improvements in lyophilization workflows.

Early construction phase test procedure development provides plenty of time for project team members, in particular the contractors whose systems will be tested, to review, ask questions, and ...