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

Post a Comment

Popular posts from this blog

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...
Post a Comment
Read more

Available Total Quality Management Tools

BayBiotech.NET Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment. Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams. Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice...
Post a Comment
Read more

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more