Information Technology (IT) Change Management

Without effective Information Technology (IT) Change Management, it is impossible for FDA-regulated and ISO environments to achieve compliance.

The reason is simple: a company needs to assure that the negative impact of change to their information technology change management system is minimized in order to avoid disruption to their development and production processes.

The only way to do this effectively is through a system for IT change management that is sanctioned by upper management and keeps all key players informed.

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Change Control - Continuous Quality Improvements in FDA and ISO Environments

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Multipurpose Tool v. Integrated Best-of-Breed Modules: What’s the Difference? Change Control - Continuous Quality Improvements in FDA and ISO Environments Automating Electronic Engineering Change Managing Change Control to Comply with FDA and EU Regulations SOP Management as a Compliance Tool in FDA and ISO Environments
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MasterControl Documents™ MasterControl Change Control™

IT change management must be able to effectively integrate with a company's other change processes. Given the number of ongoing processes for document change to formulations, design specs, SOPs, and specifications for raw materials, equipment, etc., this can be a big order.

MasterControl's Time-Tested Approach to Information Technology (IT) Change Management

MasterControl has over a decade of industry-specific experience in helping companies with IT Change Management. The MasterControl Change Control software application offers the following features and benefits:

Change form that conforms to best practice standards
IT change management software that provides form-to-form launching
Forms-based document approval process that expedites change management
Dependent routing for ensuring change control
Dynamic explorers
Powerful reporting and analytics tools

For More Information About Information Technology (IT) Change Management

For more information about IT Change Management and how MasterControl can help your company, please feel free to contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

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