QA – Quality Assurance
Much is expected from Quality Assurance personnel. As guidelines and expectations from regulators continuously change, it can be challenging to stay up to date on developments. Also guidelines describe general requirements but implementation can be difficult in practice. And every quality system requires continuous maintenance and improvement by the Quality Assurance department. Progress-PME can support your Quality Assurance department in several ways.
We have experienced consultants on staff that can (help) set up and implement a GxP or ISO based quality management system, for the development, manufacture, testing and/or distribution of medicinal products and APIs. Also we offer interim management services as well as expertise on all quality systems, whether Change Control, Deviation Management, Documentation Management, Product Quality Review, Management Review, Quality Risk Management etc.
We believe Quality Assurance is not about creating more documentation or hiring more people, but about awareness, ownership and efficiency, throughout the company. With our knowledge and experience we can ensure – together with you – continued quality compliance of your product and processes during the entire life-cycle, while maintaining the focus on your core processes.