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Engineering Change for FDA and ISO Compliance
A
Smarttech Consulting Services product story
Edited by the Manufacturingtalk editorial team
Aug 23, 2006
A white paper, prepared by MasterControl, discusses key functions of an ECM process, common concerns of manufacturers regarding the process, and the advantages of an automated ECM system
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.
A white paper, prepared by MasterControl, 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.
MasterControl's configurable, off-the-shelf products help companies effectively manage document and change control, training, audits,corrective/preventive action.
For a copy of the white paper visit the SmartTech website.
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