Engineering Change


MasterControl Realizes the Critical Role of Engineering Change Systems in cGxP Environments

An ideal manufacturing system demands flawless integration of engineering change management (ECM) process that addresses the common concerns of manufacturers regarding the process, and ultimately provides various business benefits.

Manufacturers all over the globe face the issue of controlling changes in their business. A web-based engineering change system provides thorough change management in regulated environments.

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MasterControl Provides Flawless Engineering Change Management

As time passes by, changes in the existing set of procedures become inevitable. Every manufacturer understands the implication of changes in the existing processes which is why it is necessary to incorporate an engineering change management (ECM) process that initiates and controls any modifications in a drawing, part, process, or equipment. The ECM process is crucial in ensuring the quality and safety of products. For this reason, engineering change management is the key to compliance in the FDA and ISO environments. MasterControl engineering change management software is specifically designed to ensure compliance with regulatory policies so that the manufacturing process remains cost-effectively aligned with the best business practices.

The underlying idea behind ECM is to develop a scalable mechanism that starts off with the change request initiation. MasterControl engineering change management software comprises of advanced analytics that allow project managers and other personnel to evaluate the legitimacy and feasibility of the change request. If the change request is considered valid it is only then that the change is planned which means development, testing and verification of the change in the business. This is an important stage as it is helps to ensure that the engineering change is completely tested and verified without any safety hazards. Afterwards, the final stage is change implementation during which the changes are integrated in the existing business model infrastructure. MasterControl engineering change management process is entirely web-based that helps in easily broadcasting the changes pertaining to any process across the enterprise.

The reporting tool in MasterControl engineering change management provides continuous change monitoring. Various reports can be generated to view the change risks, drivers and areas of change. In addition, management can derive several business decisions that ultimately lead the company into a perpetual state of audit-readiness. MasterControl engineering change management can also be easily integrated with other processes to ensure smooth change implementation such as the CAPA, Training, Deviations, Non Conformance etc.

About MasterControl's Engineering Change Management

MasterControl Inc. has been at the forefront of providing quality engineering change management software systems since 1993. More than 400 companies worldwide use the MasterControl suite to consistently meet FDA regulatory requirements and industry quality standards, including ISO and QS/TS.

MasterControl's configurable, off-the-shelf products help companies effectively manage document and change control, training, audits, corrective/preventive action (CAPA), and other forms-based quality processes under a single Web-based platform. MasterControl offers comprehensive technical and customer support for engineering change including product training, installation, implementation, and full-cycle validation services.

Contact MasterControl About Engineering Change

To learn more about MasterControl's engineering change software, visit a MasterControl online. or call toll free at 1.800.825.9117 to speak with a representative.