Quality System Improvement

QUALITY MANAGEMENT SYSTEM

From design, manufacturing and distribution to post-marketing activities, a well-established Quality Management System (QMS) is key to all stakeholders, especially in today’s Life Sciences Industry. We work with our clients to develop or improve their existing QMS to better meet their needs. Thus, by collaborating with us, the regulatory compliance and QMS efficiency for your organization will be managed in the best possible way. With our help, your organizations QMS will help coordinate and direct your activities to meet customer and regulatory requirements and improve the efficiency on a continuous basis. We provide consultancy in the implementation and improvement of quality management systems. This includes preparation of procedures, instructions and templates. 

The development, improvement and implementation are done in close cooperation and dialogue with our clients, to ensure that their QMS reflects their culture and way of working. An efficient and customised QMS system does not only provides a standardised way of working; it reduces cost and provides a faster time to market, does becoming value-adding to our clients. If there is a need for the implementation of a QMS software system, we can help assist in all phases from clarification, specification, implementation, integration, transfer to commissioning and validation. We provide our services to pharmaceutical and medical devices industry and their suppliers. 
Our areas of expertise lie within: 

  • ISO 9001
  • ISO 13485
  • ISO 17025 and 21 CFR 820
  • 21 CFR 210, 211 and EudraLex Volume 4.