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Implementing Quality Management Systems for FDA Environment

BayBiotech.NET
A quality management system (QMS) is a collective term for a management framework comprising of policies, plans, practices, and the supporting infrastructure by which an organization aims to reduce, eliminate and maintain non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.
Quality management systems are relevant especially for healthcare/ Biotech/Pharmaceutical industry that are regulated by FDA. All organizations whether large or small, public or private, manufacturing or service oriented are benefited by implementing a quality management system. Although a small company may have an in-house developed QMS system to manage the compliance and meet the production specifications for internal as well as external regulatory requirements, eventually it becomes difficult to manage the same in larger companies or multinationals. As it is obvious that for best results QMS must be implemented globally in an organization rather than specifically working with few departments.
Many companies have developed industry specific Quality Management System softwares and few are listed here:
IBS: http://www.ibs-us.com/
CEBOS: http://www.cebos.com/
ETQ: http://www.etq.com/
BSi: http://www.bsigroup.com
Master Control: http://www.mastercontrol.com/
In order to get the best benefits out of QMS software, while evaluating, ensure that it is customizable, scalable as well as meets the most critical cirterias of your business. Best approach would be to gather the quality needs of all the departments to ensure that the software can be customized to meet and keep the quality criterias of the organization.

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