We advise and support our clients in the development and improvement of compliance and quality management systems (business and IT) so that they can comply with the regulatory requirements applicable to their industry and at the same time develop innovative, cost-efficient and safe products.
Establishment and improvement of compliance and quality management systems in companies of the GxP-regulated industry – predefined, documented and reproducible.
Compliance, quality and traceability management help to increase confidence in processes, improve product safety and demonstrate compliance with industry laws and regulations at all times.
Compliance management interprets the legal requirements so that they can be implemented in the individual company, defines compliance goals and provides a framework that creates the required transparency in the relevant business areas.
Quality management serves as a tool for enforcing compliance requirements. As a formal construct, it defines and controls the qualitative specifications that are necessary for the manufacture and improvement of products, processes or services. In the pharmaceutical and medical technology industries, but also in health care or food production, a quality management system is required by law.
Traceability means the complete traceability of a product or system over the entire product life cycle. A functioning traceability cannot be set up after the fact, but must be planned prospectively into the processes, products, systems and services. The degree of cooperation between client and contractor (internal or external) is appropriately high.
We provide advice and support to our customers in establishing and improving compliance and quality management systems to enable them to comply with industry regulations (pre-defined, documented and reproducible) while developing innovative, cost-effective and safe products.