New White Paper discusses critical role of engineering change for FDA and ISO compliance

August 9, 2006 — /MasterControl/ — SALT LAKE CITY, Utah — Every manufacturer needs an engineering change management (ECM) process for initiating and controlling 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, ECM is key to compliance in the FDA and ISO environments.

About the White Paper:

This white paper, prepared by MasterControl Inc., discusses key functions of an ECM process, common concerns of manufacturers regarding the process, and the advantages of an automated ECM system. It describes:
–Typical ECM process and its common functions
–Issues in controlling change
–Advantages of Web-based system
–Glossary of engineering terms and acronyms

Titled “Automating Electronic Engineering Change Management Systems: Reducing Compliance Risk and Improving Product Quality,” the white paper also describes core applications of the MasterControl quality management software solution.

About MasterControl
MasterControl Inc. has been at the forefront of providing quality 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, including product training, installation, implementation, and full-cycle validation services.


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