Noncompliance among medical device developers typically falls under two areas: design control and document management. These two critical elements intersect in one place: the design history file.
Uncontrolled changes to a pharmaceutical or medical device product have the potential to affect public health and safety.
This white paper shows how medical device developers can better manage all the documentation required for a product launch.
Whether expected or unexpected, minor or complex, change is a constant in any manufacturing environment.
In highly regulated environments, changes to equipment, materials, facilities, design, processes, packaging/labeling, computer systems, documentation, etc. pose a potential risk.
MasterControl Field-Based Solutions (FBS) Management of Change (MOC)™ offers a new kind of form-based process solution that simplifies the management of change – regardless of size, source or impact.
MasterControl Change Control™ automates every step of the change control process and keeps your quality system in a state of constant audit- and inspection-readiness.