With Quality and Compliance, we help companies with the execution, interpretation and advice of regulatory and industry-driven processes. These processes can be found either in the rule book or in different standards. At Sigma, we work in cross-functional teams where we handle issues within a corporation’s various processes such as production, product development, research, testing and purchasing. We have a long and solid experience in Life Sciences.
Our quality consultants share their knowledge and experiences with customers and colleagues. They help and support each other in their respective assignments so that customers always have indirect access to more than one consultant's expertise and experience. At Sigma, we always take great responsibility to do our utmost to deliver the best possible solution. If needed, we have a whole organization that supports the skills and guidance required.
Quality & Compliance Strategy Services
- Planning and creating "QMS" structures based on regulatory requirements from, for example, the FDA, EMA, or standards such as ISO 9000, 13485 and 14000.
- Create models and overall structures.
Quality & Compliance Implementation Services
-Implementation of quality and management systems, models and / or strategies.
Quality & Compliance Performance Services
- Validation and qualification.
- Perform work in accordance with regulations and quality system.
Quality & Compliance Control Services
- Evaluate, optimize, verify, audit and improve models and strategies.