European Quality Assurance (QA) & Control Standards

Manufacturers face the burden of dealing with a separate drug agency in every country. They must contend with lingering protectionist tendencies of European governments wary of approving new drugs that compete with those produced locally. For those who want to either enter the European market or to further succeed in it or to achieve compliance with European regulatory bodies' quality control standards, a key question is: How can my pharmaceutical company obtain and maintain a marketing authorization (MA) cost-effectively and efficiently?

Breaking into a new market or exapanding within that market is never easy. In order to successfully break into or expand a business in Europe, US pharmaceutical companies must adhere to European quality assurance standards. This requires a high-level of compliance in regard to product design, manufacturing, labeling, etc. MasterControl’s quality assurance and control suite of applications empowers companies to control and maintain processes in accordance to the standards required by various international regulatory authorities.

Another reason to consider MasterControl's quality assurance suite of applications for help with complying with European quality control standards is the increased globalization and expanding businesses that many companies are experiencing across the globe. The possibility of miscommunication between different departments is too likely in global scenarios to risk nonconformance events and a high level of deviations. A cohesive and electronic platform is required to place different independent departments in a position in which they can communicate at any time and from virtually anywhere with each other. MasterControl's quality suite electronically streamlines communication, collaboration and provides a workspace for employees and management alike.

In order to provide better manageability to employees and to enhance the management of documentation, MasterControl Documents enables companies with a consolidated platform to store all documentation. This provides easy access to a centralized document archive and makes it easier to manage documentation procedures with exact accuracy. MasterControl Documents also helps eliminate any chance of non-conformity or deviance in business processes.