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How to Address the Top 6 Pains in DHF Management
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.
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Managing Change Control to Comply with FDA and EU Regulations
Uncontrolled changes to a pharmaceutical or medical device product have the potential to affect public health and safety.
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Reducing the Documentation Burden in FDA Design Control
This white paper shows how medical device developers can better manage all the documentation required for a product launch.
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Automating Electronic Engineering Change
Whether expected or unexpected, minor or complex, change is a constant in any manufacturing environment.
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Change Control - Continuous Quality Improvement in FDA and ISO Environments
In highly regulated environments, changes to equipment, materials, facilities, design, processes, packaging/labeling, computer systems, documentation, etc. pose a potential risk.
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MasterControl Field-Based Solutions (FBS) Management of Change (MOC)™
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.
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Design Control Toolkit
The Design Control Templates offering is a suite of documents that allows the user to comprehensively establish an all-inclusive Product Development Program (PDP).
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MasterControl Change Control™
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.
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MasterControl Development Excellence™ Solution Overview
MasterControl has been providing software solutions to highly regulated industries for over 25 years.
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