Enterprise Quality Management Systems for Pharmaceutical Quality Assurance

Quality assurance is a vital division of manufacturing companies throughout the pharmaceutical industry. It’s the department that is responsible assuring that all procedures, methods and specifications have been properly followed and documented. Contemporary software options in management and documentation of quality results, issues and errors are believed to improve the total quality assurance effort.

Within the pharmaceutical quality assurance arena, is a vast array of concepts that that independently or collectively have an effect on the caliber of a drug substance or drug product. Quality assurance is frequently categorized into almost 4 main sections: the production process, supervision of the process, evaluation and risk analysis. Each one of these fundamental concepts are closely monitored and managed by concerned organizations. The requirement to improve quality while reducing costs has risen dramatically as the pharmaceutical industry has become more globally oriented. A corresponding improvement in enterprise quality management systems has been vital in helping this industry to become more efficient with better quality assurance tools.

Enterprise quality management systems now available to optimize quality, ensure compliance and manage all quality processes in a centralized database. These capture information from the time of detection to the corrective action is completed. They identify high-risk events, then mitigate or prevent them through integration, automation and collaboration, and then allow trend analyses to be conducted. Many of these systems provide seamless workflows for tasks such as review, approval and release of documents, managing Corrective and Preventive Actions (CAPA) issues from corrective actions and managing customer complaints and/or non-conformance. They help organizations integrate the entire quality process and generate periodic reports on quality status to management.

It’s important for each firm to have some sort of Quality System that can reduce risk and maintain or improve compliance. To learn more about Quality Systems by checking out our solutions.

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