Skip to main content

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.

Comments

Popular posts from this blog

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...

Food Safety Bill: A major overhaul of the Food Safety System

BayBiotech.NET The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs. Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out. To read more about it follow the link