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Quality Assurance and Compliance: Industrial Environmental Management Systems BayBiotech.NET

BayBiotech.NET AERS is a computerized information database designed to support FDA’s post marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post marketing safety reports submitted in form of reports by companies. FDA recently proposed to submit the reports in electronic format in order to achieve the following objectives: 1. Eliminate the time and costs associated with submitting paper reports. 2. Expedite the agency’s access to safety information 3. Enhance agency’s ability to rapidly communicate information about suspected problems to health care providers, consumers, applicants, and sponsors within the United States and internationally. The proposal is developed considering international standards guidelines (ICH) and was open for public comment between August- November, 2009. To read more about the proposed rules follow the link: http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf

BayBiotech.NET Environmental Management Systems (EMS) can be considered as a tool to manage the environmental quality policies and procedures as per Industry standards and regulatory guidelines. EMS provides a framework to efficiently operate organizational responsibilities and activities in most efficient ways keeping the risk to the environment at its minimum. EMS also provides scope to the organization to implement corrective and preventive plan in order to continuously improve the environmental performance. An effective management system ensures that adequate efforts are properly deployed in regard to training, monitoring and reporting. Three main environmental guidelines that fall within the scope of Biotech/ Life Sciences Industry and will need integration with EMS are: RC14001: Responsible Care® (RC) is a voluntary initiative of the worldwide chemical industry with a focus on an on-going efforts to improve the safety and the protection of health and the environment, applic