The market phase in the pharmaceutical and biotechnology industry, if well coordinated and properly executed, can provide the company with rapid product uptake and dramatically increased revenues. Public relations coordinated through sales and marketing, in collaboration with the regulatory team, is very important as is manufacturing (with manufacturing quality oversight). One day of plant shut down due to a compliance audit can significantly damage revenues and the company's ability to recover. The ability to quickly demonstrate best practice policies and procedures is critical both for maintaining smooth manufacturing operations and for FDA compliance. Effective communication among teams that may not be in the same facility is also critical. MasterControl Document control and management software can help by providing a centralized, web-based document repository that enables all team members, regardless of location, to access (or automatically receive) important documents and reports. MasterControl software for automating batch records, as well as the corrective and Preventative Action (CAPA) process, while integrating it with other quality processes such as change control, SOPs, and employee retraining, enhances efficiency and reduces man hours, while ensuring FDA cGxP compliance.
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